Catalyst check off:
X 1. Cash Flow Positive Status - 5 years
X 2. Purchase building housing their cGMP registered facility for research, development, manufacturing and packaging of pharmaceutical products.
X 3. Adderall IR $335 Million Approved and Launched
X 4. Adderall XR $1.56 Billion Approved and Launched
X 5. Double digit quarterly revenues in millions
X 6. In house marketing and distribution: Kirko Kirkov, Doug Plassche and their teams
X 7. Prasco/Burel Adderall agreement starting January 1st 2024
X 8. First shipment Adderall XR to PRASCO Dec 2023
X 9. DEA increases manufacturing quotas for Adderall & Vyvance
X 10. Generic Vyvanse - $5.1 BILLION - FDA submission Dec 2023
X 11. FDA Acceptance of Generic OxyContin Sept 2023
__12. Dopamine Agonist (probably Requip XL or Mirapex ER). $12 Million
X 13. Vigabatrin Approval $233 Million
__14. Pyros Settle Vigabatrin -VigPoder trade mark challenge then Launch
__15. Generic Methotrexate Approval- Antimetabolite $42 Million
__16. $50 million in yearly revenues
X 17. Lease additional manufacturing space and storage vault for new Needle Mover ANDAs - Jan 2024
__18. Generate revenues over $20 million/quarter
__19. Generic OxyContin Approval - FIRST TO FILE Aug 17, 2023 $720 Million
__20. Prevail over Purdue in Generic OxyContin infringement suit - 6 month stay
__21. European distribution - Dexcel partnership approval by Israeli Health
__22. Full ownership of Adderall IR $ 335 Million
__23. Full ownership of Adderall XR $ 1.56 Billion
__24. Generic Concerta- $1.2 BILLION FDA submission
__25. $100 million in yearly revenue
__26. Generic Vyvanse Approval and Launch
__27. $200 million in yearly revenue
__28. Deep pocket partner for SequestOx
__29. Patented Unique ADF (w/o naltrexone)-- NDA
__30. Mikah ANDA (s)
__31. Undisclosed ANDAs/NDAs
__32. DollarLand PPS
__33. Uplist to the NASDAQ Exchange
__34. ELTP Elite Pharmaceutical Buyout - less than 2 1/2 years from Feb 2024
__35. Vegas Baby !!!!!!!
X 36. PE below 8

Ive never seen anything like this on the OTC

X 1. Cash Flow Positive Status - 4+ years
X 2. Purchase building which houses their cGMP registered facility for research, development, manufacturing and packaging of pharmaceutical products.
X 3. Adderall IR $335 Million approved and launched
X 4. Adderall XR $1.56 BILLION approved and launched
X 5. In house marketing and distribution: Kirkov
__6. Generic OxyContin- FIRST TO FILE Aug 17, 2023 $720 Million
__7. Prevail over Purdue in Generic OxyContin infringement suit
X 8. DEA increases manufacturing quotas of Adderall & Vyvance
X 9. Double digit quarterly revenues in millions.
__10. Full ownership of Adderall IR $ 335 Million
__11. Full ownership of Adderall XR $ 1.56 BILLION
__12. Generic Concerta- $1.2 BILLION submission
X 13. Generic Vyvanse- $5.1 BILLION - submitted to FDA Dec 2023
__14. Vigabatrin - VigPoder approved Pyros $233 Million trade mark challenge
__15. Dopamine Agonist (probably Requip XL or Mirapex ER). $12 Million
__16. Patented Unique ADF (w/o naltrexone)-- NDA
__17. Mikah ANDA (s)
__18. Undisclosed (s)
__19. Antimetabolite ANDA- Methotrexate -$600 Million
__20. Undisclosed Antimetabolite ANDA- $42 Million
X 21. Prasco/Burel Adderall agreement January 1st 2024
X 22. First shipment Adderal XR to PRASCO Dec 2023
__23. Generic Vyvanse Approval
__24. Triple digit yearly revenues in millions.
__25. European distribution Dexcel partnership approval by Israeli Health
__26. Purchase or rent additional manufacturing and storage space for new ANDAs
__27. DollarLand PPS
__28. Uplist to the NASDAQ Exchange
__29. THE Buy Out !
__30. Vegas Baby !!!!!!!

The Gem of the OTC:
Ive never seen anything like this on the OTC

X 1. Cash Flow Positive Status - 4+ years
X 2. Purchase building which houses their cGMP registered facility for research, development, manufacturing and packaging of pharmaceutical products.
X 3. Adderall IR $335 Million approved and launched
X 4. Adderall XR $1.56 BILLION approved and launched
X 5. In house marketing and distribution: Kirkov
__6. Generic OxyContin- FIRST TO FILE Aug 17, 2023 $720 Million
__7. Prevail over Purdue in Generic OxyContin infringement suit
X 8. DEA increases manufacturing quotas of Adderall & Vyvance
X 9. Double digit quarterly revenues in millions.
__10. Full ownership of Adderall IR $ 335 Million
__11. Full ownership of Adderall XR $ 1.56 BILLION
__12. Generic Concerta- $1.2 BILLION submission
X 13. Generic Vyvanse- $5.1 BILLION - submitted to FDA Dec 2023
__14. Vigabatrin - VigPoder approved Pyros $233 Million trade mark challenge
__15. Dopamine Agonist (probably Requip XL or Mirapex ER). $12 Million
__16. Patented Unique ADF (w/o naltrexone)-- NDA
__17. Mikah ANDA (s)
__18. Undisclosed (s)
__19. Antimetabolite ANDA- Methotrexate -$600 Million
__20. Undisclosed Antimetabolite ANDA- $42 Million
X 21. Prasco/Burel Adderall agreement January 1st 2024
X 22. First shipment Adderal XR to PRASCO Dec 2023
__23. Generic Vyvanse Approval
__24. Triple digit yearly revenues in millions.
__25. European distribution Dexcel partnership approval by Israeli Health
__26. Purchase or rent additional manufacturing and storage space for new ANDAs
__27. DollarLand PPS
__28. Uplist to the NASDAQ Exchange
__29. THE Buy Out !
__30. Vegas Baby !!!!!!!

October 25, 2023
$ELTP Elite Pharmaceuticals. This is a Pharma Company that has all the Validation, Products now , Pipeline Products on the way .
--
what makes them different than the other OTC companies, validation there, verified Fin's audited, SEC Reporting , Brick and Mortar office Bld
a. Real Revenue : https://www.otcmarkets.com/stock/ELTP/financials (Audited)
b. Real Products: https://elitepharma.com/products/
c. Real Profits : https://elitepharma.com/products/
d. New product on PR and 8-k enters into a 720 Million dollar market
https://www.otcmarkets.com/filing/html?id=16947106&guid=hb5-kFxzfus2dth
e. OTCQB Certified and SEC Reporting : https://www.otcmarkets.com/stock/ELTP/profile
f. Proprietary Technology and Trademark: https://elitepharma.com/technology-overview/
g. Superbowl R and D , Medical Research Team (click on Bios) : https://elitepharma.com/management-key-employees/
h. Has their own Large building, Labs, R and D Facility , Production, Packaging , employees under one roof. : https://elitepharma.com/our-facility/
i. Full Investor Relations link to all SEC, Reports, Quality and Validations: https://elite.irpass.com/investor_relations
j. Is the Real DEAL: https://elitepharma.com/

Pharmacy Chain Stores
X Walgreens Company 9,323
X CVS Health 9,600
X Walmart 4,865
—Rite Aid 2,721
—Kroger 1,956
—Albertsons 1,713
—AmerisourceBergen 1,961
—Publix 1,084
—McKesson 1,556
—Costco Wholesale 550
—Cardinal 518
—Ahold Delhaize Usa 521
—H E B Grocery 270
—Meijer Great Lakes 238
—Southeastern Grocers 327
—Hy Vee Inc 249
—Kaiser Permanente 131
—Giant Eagle. 204
—Ahold Delhaize 170
—Wegmans 88

X

X 1. Full ownership of Adderall IR $335 Million
X 2. In house marketing and distribution: Kirkov
X 3. Generic OxyContin- FIRST TO FILE Aug 17, 2023 $720 Million
—4. Full ownership of Adderall XR $ 1.56 Billion
—5. Generic Concerta- $1.2 BILLION
—6. Generic Vyvanse- $5.3 BILLION
—7. Vigabatrin
—8. Dopamine Agonist (probably Requip XL or Mirapex ER). $12 Million
—9. Patented Unique ADF (w/o naltrexone)-- NDA
—10. Mikah ANDA
—11. Undisclosed
—12. Antimetabolite ANDA- Methotrexate -$600 Million
—13. Undisclosed Antimetabolite ANDA- $42 Million
—14. Prasco/Burel Adderall agreement
—15. Dexcel partnership approval by Israeli health for European distribution

jour_trader

Re: WeeZuhl post# 388396

Tuesday, September 26, 2023 11:30:39 AM

Post#
388401
of 388413
Here is wording from Q4 cc on PDUFA date that kicked off for Oxy at time of partial filing or we are so led to believe:

“Once we did the insufflation study, we are resourced because the results were positive and we wanted to make an announcement. But then we learned that there are three other companies that are doing the same thing and we did not want them to beat us to the punch by knowing that we just made an announcement that we're going to file. So we had to be quiet, wait till we file a partial application to get the PDUFA date going, okay? And now I can tell you about it. The full application should be filed by August 1st and hopefully the FDA would accept it. That usually takes 45 to 60 days and once they do, we'll make an announcement. “

X 1. In house marketing and distribution: Kirkov
X 2. Generic OxyContin- FIRST TO FILE Aug 17, 2023 $720 Million
X 3. Full ownership of Adderall IR $335 Million
—4. Full ownership of Adderall XR $ 1.56 Billion
—5. Generic Concerta- $1.2 BILLION
—6. Generic Vyvanse- $5.3 BILLION
—7. Vigabatrin
—8. Dopamine Agonist (probably Requip XL or Mirapex ER). $12 Million
—9. Patented Unique ADF (w/o naltrexone)-- NDA
—10. Mikah ANDA
—11. Undisclosed
—12. Antimetabolite ANDA- Methotrexate -$600 Million
—13. Undisclosed Antimetabolite ANDA- $42 Million
—14. Prasco/Burel Adderall agreement
—15. Dexcel partnership approval by Israeli health for European distribution

X 1. In house marketing and distribution: Kirkov
X 2. Generic OxyContin- FIRST TO FILE Sept 25, 2023- $720 Million
—3. Generic Concerta- $1.2 BILLION
—4. Generic Vyvanse- $5.1 BILLION
—5. Vigabatrin
—6. Dopamine Agonist (probably Requip XL or Mirapex ER). $12 Million
—7.Patented Unique ADF (w/o naltrexone)-- NDA
—8. Mikah monster
—9. Undisclosed
—10.:Antimetabolite ANDA- Methotrexate -$600 Million
—11. Undisclosed Antimetabolite ANDA- $42 Million
—12. Full ownership of Adderall XR
—13. Prasco/Burel Adderall agreement
—14. Dexcel partnership approval by Israeli health for European distribution

$1.38
1. Generic OxyContin
2. Generic Concerta
3. Generic Vyvanse
4. Vigabatrin
5. NDA Unique ADF (w/o naltrexone)
6. Mikah monster
7. Undisclosed
8. Extended release generic dopamine agonists.
9. Antimetabolite ANDA
10. Full ownership of Adderall XR

Sorry you got caught ?

You were right to leave when you did we are up 40 % +
Last shorts are getting burned
desperation is setting in for the ones you left.

$$$$$$$$$$$$$$$4

Don't forget to tell Ihub to renew your subscription.

Its about To Get Real !!!!!!!!!!!!!!!!!!!

HammerTime !!!!!!

HammerTime !!!!!!!!!!!!!

Elite's Monster Unique second generation IR ADF is 90% cheaper to produce compared to ADFs containing Naltrexone. It can also be used with CNS stimulants to make them abuse deterrent.
The holy grail of IR ADFs trials resume in 2022
Making others obsolete.

Hammer locking the IR ADF market in 2022

Patent Pending

Quote Nasrat:

Secret MIKAH Program

signed back on December 3, 2018:


NOTE 20. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA LLC

-- On December 3, 2018, the Company executed a development agreement with Mikah, pursuant to which Mikah and the Company will collaborate to develop and commercialize generic products including formulation development, analytical method development, bioequivalence studies and manufacture of development batches of generic products.

-- The Company received a total of $480,000 from Mikah as an advance payment for the purchase of pharmaceutical materials relating to future product development conducted pursuant to this agreement. This amount was recorded as a deposit and contained within the customer deposits financial statement line item on the consolidated balance sheet.

-- As of the date of this report, the Company has purchased raw materials with an aggregate cost of $542,214 pursuant to this agreement. As of March 31, 2020, the balance due from Mikah was $62,214 and was included in the financial statement line of prepaid expenses and other current assets on the accompanying consolidated balance sheet.

again, nothing to do with surgilight

nothing to do with surgilight

i think this company is not operational any longer

yes this is delisted

Elite Pharmaceuticals Reports Positive Topline Results from SequestOx™ Pilot Study
PRESS RELEASE GlobeNewswire
Jan. 30, 2018, 02:35 PM
NORTHVALE, N.J., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today reported positive topline results from a pilot study conducted for SequestOx™, Elite’s immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology. An objective of the study was to assess whether the reformulated SequestOx could achieve a Tmax (the mean or median time to the maximum drug concentration in subjects) comparable to the reference drug, Roxicodone, when dosed with the standard high fat meal specified by the FDA. As opposed to the earlier formulation, based on these pilot results, the modified SequestOx™ is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions. Elite intends to review with the FDA the study results and discuss the pharmacokinetic study requirements for a re-submission of the NDA.

IMS reports approximately $400 million annually in revenue for the immediate release oxycodone generic market. There is currently one other approved, but not yet commercialized, abuse-deterrent product and many non-abuse deterrent generic products in this market. Immediate release oxycodone is one of the most highly abused opioids in the U.S.

SequestOx is Elite’s investigational abuse-deterrent immediate-release oxycodone product with sequestered naltrexone for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The study was a Phase 1 pilot, randomized, single-dose, single period, pharmacokinetic study in healthy male and female volunteers in the fed state. The test products included two formulation modifications of SequestOx, a unique abuse-deterrent formulation without sequestered naltrexone, and a reference product. The following table summarizes the Tmax results for the pilot study.

Parameter Treatment N* median min max
Tmax Reference 12 2.25 1.28 5.00
Test-A 12 2.50 1.25 5.00
Test-B 11 3.00 1.00 4.00
Test-C 11 2.50 0.50 3.00
* N=number of subjects

“The reformulated SequestOx™ performed well in this pilot study and should provide a path forward for overcoming prior Tmax issues under fed conditions,” commented Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “I’m excited about these outstanding results and look forward to reviewing them with the FDA.”

Company name: XenoPort, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=XNPT+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=XNPT+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=XNPT+Industry

## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/XNPT/news - http://finance.yahoo.com/q/h?s=XNPT+Headlines

## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/XNPT/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/XNPT/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=XNPT+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/XNPT
DTCC (dtcc.com): http://search2.dtcc.com/?q=XenoPort%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=XenoPort%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=XenoPort%2C+Inc.&x=0&y=0

## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/XNPT
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001130591&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/XNPT/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/XNPT/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=XNPT&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=XNPT
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/XNPT/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=XNPT+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=XNPT+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=XNPT
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=XNPT
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=XNPT+Cash+Flow&annual

## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/XNPT/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=XNPT+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/XNPT.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=XNPT
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/XNPT/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/XNPT/insider-transactions

## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/XNPT
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/XNPT
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/XNPT:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=XNPT
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=XNPT

Questions for CC.

Questions for CC.

How does the DEA allocate the quotas for Adderall ?
How is the percentage determined for each Pharma and what time of year is it released?

“Can you provide any more details on the Development Agreement between Elite and Mikah that was signed in December 2018?"

Is Epic out of the picture..

Is it time to have the company valuation done again ?

Pharmacies *************# of stores

1. CVS 9700 —————check
2. Walgreens 9277 ——check
3. Walmart 3646
4. Rite Aid. 4608
5. Kroger 1156 ————-check
6. Target 1672
7. Kaiser 290
8. Sears 1002
9. Safeway 900
10. Medicine Shoppe 564
11. Dominic’s 719
12. Publix 710
13. Costco 323
14. Hy-Vee 202
15. Winn-Dixie 390
16. Giant Eagle 187
17. Meijer 167
18. Cardinal 131
19. Wegmans 102

STEADY-PD III RESULTS Isradipine Trial for Parkinson's Disease PD

STEADY-PD III trials results will be released at the 2019 American Academy of Neurology meeting in Philadephia on the 4th-10th May, 2019.

https://scienceofparkinsons.com/2019/02/28/february-2019/#more-52900

steady PD results
steady-PD III

steady-pd

STEADY-PD III

https://steadypd3.com

Israpipine Parkinson's Disease

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147410827

[

SLGTQ FINRA deleted symbol:

http://www.otcbb.com/asp/dailylist_detail.asp?d=10/31/2014&mkt_ctg=NON-OTCBB

Reasons to invest in AMMX - has potential to hit dollarland

- No dilution. Management taking restricted shares as salary. shows belief of Management in stock price
- 30 year old company in Chico, CA. got hit during the recent recession. diversified operations to international countries, and is now making a comeback. generating contracts in latin america, across US, and potentially huge projects in Africa. AMMX generated $20 to $30 million pre-recession though with less profit margins.
- low float - 230 million. OS - 520.1 million. restricted - 288 million. (out of the restricted shares, management holds 180 million)
- positive cash flow of $817K per 2013 Annual financials released today. Inventory is $955K, Accounts Receivable is $748K
- No note receivables
- In 2013, revenue increased by 79 percent & net income increased by 362 percent compared to 2012 financials.
- During the first 3 months of 2014, company has already announced contracts worth $2.727 million. compare it to 2013 annual revenues of $6.1 million.
- huge pending projects(projects in the range of $270 million, $500 million, $40 million etc) in Africa. even if AMMX can secure one of these projects, we are looking at a huge increase in PPS.
- high probability of securing the $270 million Niger project. during the recent conference call, Lee Hamre(CEO) mentioned that Niger PM visited AMMX facilities in Chico, CA. Lee made 30+ trips to Africa establishing relationships, and building the ground work during the past 5 years. IMO, it's not a matter of 'if', but it's about 'when' we hear the news of AMMX securing this $270 million contract.
- CEO is highly confident of securing the $270 million Niger deal. should get more details during next week.
- stock is trending up, and is establishing support at key levels.
- company is issuing PRs on a regular basis. A very transparent company in terms of communications with share holders - conference calls, regular PRs etc.
- As MarqueeGemFinder pointed out, with the new EPA 2015 changes, AMMX is rightly situated to take advantage of the huge demand for US domestic core operations for handlers and equipment upgrades.
- strong possibility that AMMX will hit dollar land in 2014. Once AMMX secures one big project, AMMX would have huge cash flow, and I think the barrage of other huge contracts would follow.

-----------------------------------------------------------------------------------------

Total Number of Shares Issued and Outstanding: 520.1 million
Float : 230 million, Restricted : 280 million (out of the restricted shares, management holds 180 million shares)

-----------------------------------------------------------------------------------------
true valuation of AMMX based on 2013 financials released today. (http://finance.yahoo.com/news/ameramex-international-reports-end-financials-140000619.html )

The company reported revenue of approximately $6.1 million with gross profit of $2.6 million compared to revenue of approximately $3.4 million with gross profit of $2.4 million for the year ended December 31, 2012.

Borrowing from stervc's post - With AMMX, it is already known where such Sector/Industry that AMMX would trade. This particular Industry already has a growth rate (P/E Ratio) for the stocks that exists within such Industry. Logically, AMMX would be classified to exist and trade within the Industrial Equipment & Components Industry within the Industrial Goods Sector of which already has a 31.00 for its P/E Ratio as indicated below:
http://biz.yahoo.com/p/621conameu.html

$2,600,000 Net Profit Margin ÷ 520,100,00 Shares (OS) = .0049 EPS
0.0049 EPS x 31.00 P/E Ratio = $0.15 AMMX Per Share Valuation

Conservatively, even if we apply a P/E ratio of 10, share price should be 0.0049 EPS x 10.00 P/E Ratio = $0.49 AMMX Per Share Valuation (4.9 cents)

As of today AMMX is trading around 3 cents, which is still a bargain when compared to valuation based on 2013 financials.

-----------------------------------------------------------------------------------------

During the first 3 months of 2014, AMMX announced contracts that are worth $2.727 million. If AMMX goes at the same pace, we are looking at revenues > $10 million at end of year 2014.

In 2013, AMMX had $2.6 million profit on a $6.1 million revenue - which is a 42.6% margin. Assuming we have similar margins in 2014, for a $10million revenue, we are looking at a profit of $4.26 million.

For a $4.26 profit margin, valuation of AMMX would be
$4,260,000 Net Profit Margin ÷ 520,100,00 Shares (OS) = .0081 EPS
0.0081 EPS x 31.00 P/E Ratio = $0.25 AMMX Per Share Valuation

Conservatively, even if we apply a P/E ratio of 10, share price should be 0.0081 EPS x 10.00 P/E Ratio = $0.08 AMMX Per Share Valuation

These are very extreme conservative valuations.

-----------------------------------------------------------------------------------------

When we get the $270 million Niger contract, refer to stervc's valuations of hitting $1.41 per share (conservative) to $4.20 per share.

** NTEK's 4K Studios, has entered into a global distribution agreement with Red Bull Media House, FACT!!
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** NanoTech is partnering with Ittiam Systems, a world leader in highly-optimized HEVC and VP9 software decoder solutions, to provide NanoTech’s Nuvola NP-1™ and NP-C™ 4K Ultra HD streaming media players with HEVC (H.265) and VP9 support ... NanoTech will join Ittiam in providing demonstrations of the newly enhanced players at Ittiam’s NAB 2014 Booth SU11021 (Upper South Hall), FACT!!
** NanoTech and Akamai will demonstrate how 4K content can be uploaded to Akamai’s global content delivery network (CDN) and streamed to a consumer’s Ultra HD TV using NanoTech’s Nuvola NP-1 4K streaming media player at the Akamai NAB Booth SL4525 in Las Vegas April 7-10, FACT!!
** That is HUGE, FACT!!
** Akamai's network is one of the world's largest distributed-computing platforms, responsible for serving 30 percent of all web traffic, FACT!!
** Akamai trades on the NASDAQ, FACT!!
** This Nanotech Entertainment & 11 Giraffes Nuvola NP-C 4K Streaming Digital Signage Webinar was masterful, FACT!!
http://www.youtube.com/watch?v=ard_noiiB7w
** NanoTech is partnering with Skymedia and has integrated the Nuvola NP-1™ Streaming 4K Media Player into their TVs, FACT!!
** Just more Revenue for this juggernaut, FACT!!
** It's all about Revenue and Profits and NanoTech is already PROFITABLE, FACT!!
** NanoTech is now expanding 4K Studios and adding yet another 4K Ultra HD scanner to their 24/7 operations is indicative of a thriving business in Beast Mode, FACT!!
** NanoTech is partnering with SonicPool who has done post-production work on Academy Award nominated films and the soon-to-be-released movie “Left Behind” starring Nicholas Cage, FACT!!
** This NanoTech Entertainment Shareholder Letter is absolutely MONUMENTAL, FACT!!
http://www.otcmarkets.com/otciq/ajax/showNewsReleaseDocumentById.pdf?id=594147093

** NTEK just posted another stellar quarter with OVER $5 Million in Revenue, FACT!!
** NTEK’s financials are ROBUST, FACT!!
** NanoTech Entertainment Announced a New Research and Development Facility in Las Vegas which will concentrate on the xext Generation of Gaming & Display Technology, FACT!!
** This is another major development that will expand NanoTech's business footprint and enhance NanoTech's ability to attract emerging and top talent, FACT!!
** The appointing of Industry Heavyweight Mitch Lowe, Co-founder of NETFLIX and Former President and Chief Operating Officer of REDBOX, to head up NanoTech's Content Advisory Board and cultivate major studio relationships along with expanding the 4K Ultra HD library is absolutely Mind Blowing, FACT!!
** Mitch Lowe's industry connections are absolutely ENORMOUS, FACT!!
** NanoTech has a technology/platform partnership involving NanoTech’s commercial grade Nuvola NP-C™ 4K media player and 11Giraffes digital signage system, FACT!!
** 11Giraffes places their products in a wide range of industries including retail, hospitality, restaurant, assisted living, automotive, financial institutions, medical and dental offices, country clubs, and c-stores, FACT!!
** UltraFlix has launched with key retailers and distributors in anticipation of the full NP-1 debut, FACT!!
** That is just the beginning, FACT!!
** The photo of the Hollywood warehouse tour for content is an eye opener, FACT!!
** The price hike for the basic 4K rendering service of a 2 hour film to $29,999 signals that the Market has spoken, FACT!!
** That bodes well for ongoing Massive Revenue for 4K Studios, FACT!!
** The picture of those Foxconn boxes is a clue that even the low IQ crowd can decipher, FACT!!
** NanoTech has the great Alan Stone (Legendary Co-Founder of Nintendo of America and Former Sega Enterprises President and CEO) serving as Chief Operating Officer, FACT!!
** So now, JVC, a renowned Japanese international consumer and professional electronics corporation based in Yokohama, Japan with over 19,000 employees is using the Nuvola NP-1 as the reference platform for their 4K UHD projectors, FACT!!
** Basically, all JVC 4K UHD projector demonstrations are given using the Nuvola hardware, FACT!!
** That's a clue that NanoTech is the REAL DEAL, FACT!!
** NanoTech unveiled their NEW corporate website ntek.com, FACT!!
** The list of NanoTech Media Partners are sensational, FACT!!
** NanoTech has entered into a global distribution agreement with Global New Age Media (GNAM®), the largest content provider in Dubai, for distribution of "Mantera" with UltraFlix™, NanoTech’s streaming 4K Ultra HD service, FACT!!
** There is HUGE money in Dubai, FACT!!
** The testimonial by Ms. Fit of her visit to the NTEK Booth at the 2014 CES was simply Sensational, FACT!!
** NanoTech has and are in the process of completing many contracts with distributors and filmmakers who have content in native 4K including Feature Films, Documentaries and TV series, FACT!!
** This Outstanding David Foley Interview at the 2014 CES done by Blorgalakt introduces the AWARD WINNING Nuvola NP-1 and is appreciated by ALL, FACT!!
** Ted Schilowitz, Co-founder of Red Camera Company is a HUGE advocate of the AWARD WINNING Nuvola NP-1 and is plainly demonstrated in this Ted Schilowitz Video interview from the 2014 CES, FACT!!
** Ted Schilowitz sure was animated and excited about the AWARD WINNING Nuvola NP-1 as he was filming for his 4K Experiment online blog, FACT!!
** Ted Schilowitz, currently a consultant for FOX, stated that the Nuvola NP-1 "streaming was impressive!", FACT!!
** This HUGE BIG video of NanoTech at the 2014 CES REALLY captures the action around the Booth, FACT!!
** There is incredible information in that BIG video such as the functionality and capabilities of the Nuvola NP-1 and a glimpse at the Business Model for 4K content, FACT!!
** BIG is HUGE and NanoTech is a MONSTER, FACT!!
** NanoTech Entertainment's Nuvola NP-1 WON Ultra HDTV Magazine’s 2014 Best of CES Ultra HD Media Player Award, FACT!!
** NanoTech Entertainment's Nuvola NP-1™ 4K Ultra HD streaming video player WON the Storage Visions® 2014 Visionary Product Award in the Home Entertainment category, FACT!!
** So the Nuvola NP-1 will be called "The Award Winning Nuvola NP-1" from now on, FACT!!
** That means the Nuvola NP-1 is Really Truly REAL, FACT!!
** Lumaforge CEO Neil Smith's interview with NTEK's VP of Business Services Jim Rossi at the 2014 CES was more confirmation that NTEK is the REAL DEAL, FACT!!
** This David Foley interview on Radio show "Into Tomorrow" at the 2014 CES was Convincing and Masterful, FACT!!
** NanoTech will be attending Major Trade Shows in 2014 such as the NAB, NAPTE, SXSW and more in 2014, FACT!!
** This NanoTech Entertainment 2014 Forecast and Budget is a Jaw Dropper, FACT!!
** This is one AMAZING growing company with 2014 projected Revenue of OVER $33mm, upcoming Audited Financials, Uplisting to OTCQB in 2014, Quarterly Cash Dividends starting in April and Share Buyback starting in July, FACT!!
** NanoTech is creating REAL Legitimate American Jobs as the company has already grown to approximately 45 employees, FACT!!
** This does not even include other ancillary jobs (partners, manufacturing, distribution, etc.) that NanoTech is helping to support, FACT!!

** Everyone is excited for the imminent announcement of the Brick and Mortar stores where the Nuvola NP-1 will be available, FACT!!
** These pictures of the Nuvola NP-1 look tremendous, FACT!!
** The NanoTech Booth design for the 2014 CES was simply awesome, FACT!!
** NanoTech was actually at the CES "South Hall" in Las Vegas, FACT!!
** All those "Epic Fail" accusations that NTEK was NOT going to have a major presence at the 2014 CES was just silly, FACT!!
** Everyone is excited for the imminent release of the Revolutionary Nuvola NP-1, FACT!!
** NanoTech's UltraFlix IPTV/OTT 4K Channel will be debuting on Super Bowl Sunday, February 2, 2014, FACT!!
** The David Foley Tweaktown interview at the 2014 Storage Visions Conference was another Eye-Popper, FACT!!
** NanoTech’s UltraFlix IPTV/OTT 4K Channel was granted the License for Worldwide Distribution of 4K Moving Murals, FACT!!
** NanoTech is teaming with Ingram Micro (the world’s largest wholesale technology distributor) for U.S. Distribution of Nuvola NP-1 4K Ultra HD Streaming Video Player, FACT!!
** Ingram Micro is a Fortune 100 Company that is traded on the NYSE, FACT!!
** The Press Release was heralded on the Ingram Micro Financial pages too, FACT!!
** NanoTech is Global, FACT!!
** NanoTech wrestled away former Roku executive Aaron Taylor to oversee Sales and Marketing activities for two industry firsts: NanoTech’s Nuvola NP-1™ 4K streaming media player and UltraFlix™ 4K streaming video distribution service, FACT!!
** Nuvola products are being manufactured by Foxconn (who also builds the iPhone and PlayStation), the world-leader in consumer electronics manufacturing, FACT!!
** There appears to be a MASSIVE Fear of the Nuvola, FACT!!
** There just aren't enough superlatives to describe NanoTech, FACT!!
** NanoTech Entertainment Opening a 4K Studios Office in Hollywood is simply Brilliant, FACT!!
** NanoTech's New TV-U1 TV Tuner option for Nuvola NP-1 4K Ultra HD Streaming Media Player which gives users the ability to watch Broadcast TV upscaled to 4K is Magnificent, FACT!!

** UltraFlix™, NanoTech’s streaming 4K Ultra HD service, has been granted exclusive 4K rights to distribute the "The History of Video Games" documentary named "World 1-1", FACT!!
** The Legendary Alan Stone (NTEK COO) would fit nicely in that documentary, FACT!!
** I have forwarded each of NanoTech's Press Releases to Barrons, FACT!!
** Everyone LOVES NanoTech, FACT!!
** NanoTech is ALREADY Profitable, FACT!!
** PROFITS are what business is all about, FACT!!
** NanoTech has already made a 200% PROFIT on the Sammy Davis, Jr. collection, FACT!!
** NanoTech will be delivering Rare & Unique Sammy Davis, Jr. content on Streaming Channels, FACT!!
** Sweet DEAL with Graphin Co to sell NanoTech products in the Asia market, FACT!!
** The "Nuvola NP-H1 4K UltraHD Media Player" showcased original 4K content at the 2013 International Technical Exhibition on Image Technology and Equipment in Yokohama, Japan, FACT!!
** Abraham Joffe, an award-winning cinematographer and regarded as one of Australia’s top DSLR film makers is using the Nuvola NP-H1, FACT!!
** NanoTech employs over 50 people, FACT!!
** NanoTech is the most transparent penny stock company around, FACT!!
** The bottom line is REVENUE and PROFITS, FACT!!
** There seems to be a Fear of 4K Studios too, FACT!!
** Containers for CIAO Telecom have been sent to Brazil, FACT!!
** The visit by Lonnie Dillard to the San Jose, California facility was a tremendous and impressive testimonial, FACT!!
** The visit by Antcoster to NanoTech's East Coast operations located in East Bridgewater, Massachusetts was a tremendous and impressive testimonial, FACT!!
** The visit by Twobits and the Late Great mikeski to NanoTech's East Coast operations located in East Bridgewater, Massachusetts resulted in a tremendous and impressive testimonial, FACT!!
** It is amazing how Every Shareholder who has visited NanoTech at their facilities or at Trade Shows have come away Super Impressed, FACT!!
** We should all honor and remember mikeski ... Go mikeski!! ... Go mikeski!! , FACT!!

** NanoNation is unbelievably strong, FACT!!
** NanoTech sponsored Care Packages for American troops stationed in Afghanistan during the Holidays, FACT!!
** ALL attempts to destroy a Real American Business with Real American Jobs and hard working people's livelihoods is Reprehensible and NOT COOL, FACT!!
** Everyone now knows that ENORMOUS PRs are imminent, FACT!!
** NanoTech is ALREADY Profitable, FACT!!
** This David Foley interview by IntelligentPMC from the Createasphere 2013 ETE is Sensational, FACT!!
** This Incredible 4K Studios video by BIG is an absolute "Eye Opener", FACT!!
** The knowledge that NTEK is already in deep discussions with 4 very well known production companies makes everyone Giddy, FACT!!
** NanoTech will be including the 4K remastered titles on the UltraFlix Channel which is another significant Revenue Stream, FACT!!
** NanoTech has a contract to re-master 80 Polish films to 4K, FACT!!
** Everything comes right back to REVENUE, FACT!!
** Last January, at the 2013 CES, NanoTech Entertainment (NTEK) negotiated a Partnership with EB2 Global Manufacturing, FACT!!
** The David Foley DEATHSQUAD Interview is a Classic, FACT!!
** NanoTech's products featured at the 2013 SMPTE Conference as shown in Peterminator's VIDEO was Outstanding, FACT!!
** NanoTech CEO and Board of Directors have been buying NTEK shares on the Open Market as high as .17, FACT!!
** New VP of Gaming Technology, Aaron Hightower has been buying NTEK shares on the Open Market too, FACT!!
** All NanoTech employees are fully engaged and know where this Stock going soon, FACT!!
** NanoTech has started the process of Audited Financials and Uplisting to the OTCQB - That is ENORMOUS, FACT!!

** NanoTech (David Foley) was interviewed by NBC News Radio (Live with Aaron and Kelly), FACT!!
** NanoTech's pre-orders for the Nuvola NP-1 is through the roof, FACT!!
** BIG had a very successful visit to the NanoTech San Jose Office and San Francisco 4K Studios, FACT!!
** NanoTech is piling up Revenue out the Wazoo, FACT!!
** NanoTech is expanding their Casino Gaming Business, FACT!!
** David Foley's DeathSquad interview was sensational, FACT!!
** NanoTech can be reached by their Investors Relations email address ir@nanotechent.com or via Phone at (408) 414-7355, FACT!!
** NanoTech's 4K Studios has a REAL SAN FRANCISCO Address now, FACT!!
** Claims that 4K Studios does Not exist or that there is No "4K Studios Address" is just plain silly, FACT!!
** It is now understood by everyone that construction was performed on the NanoTech's 4K Studios facility and it has 3700 Square Feet, FACT!!
** San Francisco has a great talent pool in the Media space, and NanoTech already has highly skilled people joining the 4K Studios staff, FACT!!
** NTEK is always in the Top 5 of the "Most Read" list, FACT!!
** NanoTech does NOT work willy-nilly ... The first impression is important, FACT!!
** NanoTech amazingly always seems to pay attention to detail in order to get things Right, FACT!!
** Now is a great time to assume a position with this Beast of company, FACT!!

** NanoTech is running the business with the Highest Integrity, FACT!!
** NanoTech is building a business properly, FACT!!
** NanoTech has reduced the Share Structure in 2013, FACT!!
** Nanotech is ALREADY Profitable, FACT!!
** NanoTech had over $3 Million in Revenue in Q3, blowing away projections, FACT!!
** NanoTech had over $5 Million in Revenue in Q4, blowing away projections, FACT!!
** NanoTech is on pace to Obliterate 2014 Revenue projections, FACT!!
** NanoTech has Multiple Revenue Streams, FACT!!
** NanoTech is selling products on Amazon, FACT!!
** NanoTech is selling the Nuvola, FACT!!
** NanoTech is selling the nanoSign, FACT!!
** NanoTech shipped pallets of the nanoSign to Spain and the Ukraine, FACT!!
** Comedian, Radio/TV personality and actor Adam Corolla really likes the nanoSign, FACT!!
** The nanoCharge is Sweet, FACT!!
** NanoTech's selection of the nVidia Tegra-4 to power the Nuvola NP-1 was brilliant, FACT!!
** NanoTech's deal with CIAO Telecom will be yielding Massive Revenue, FACT!!

** NanoTech is producing Real 4K Content, FACT!!
** NanoTech has Hollywood Represention (Sufrin and Fried) now for Hollywood Studios Content Licensing, FACT!!
** Sufrin and Fried have prior affiliations at Paramount Pictures and Metro-Goldwyn-Mayer, FACT!!
** NanoTech has an A+ Rating from the Better Business Bureau, FACT!!
** NanoTech is a juggernaut, FACT!!
** NanoTech's partnership with SEIKI is HUGE, FACT!!
** NanoTech's bundle deals are a Super Value, FACT!!
** NanoTech Gaming Division is a super underrated part of the business, FACT!!
** NanoTech debuted their 4K Studios Content at the American Film Market from November 6-13 in Santa Monica, FACT!!
** The American Film Market is where almost One Billion Dollars of deals are sealed every year, FACT!!
** The 2013 AFM has already paid tremendous dividends for NanoTech, FACT!!
** NanoTech showcased 4K Content with their revolutionary Nuvola NP-H1 4K Player with partner Lumaforge at Createasphere's Entertainment Technology Exposition (ETE) 2013 in Burbank, California, FACT!!
** EB2 also has a distribution and sales network that covers all of Asia, FACT!!
** EB2 is manufacturing NanoTech's consumer electronics and gaming products including the Mot-Ion Pinball Kit and MultiPin Digital Pinball Machine, FACT!!

** NanoTech is represented in the UK and throughout Europe with Gaming partner Electrocoin, FACT!!
** NanoTech raked in over $440,000 in Q3 Revenue on Gaming alone, FACT!!
** NanoTech opened an R&D facility on the East Coast, FACT!!
** NanoTech hired 15 new employees that are working 3 shifts at the R&D facility, FACT!!
** NanoTech's stock will be attracting more and more Deep Pockets and Institutional investors, FACT!!
** NanoTech has been selling the Nuvola NP-H1 to companies (like JVC) to power their 4K Demos at Trade Shows, FACT!!
** LumaForge will be selling NanoTech products, FACT!!
** NanoTech Tripled its Network Operations Equipment and Video Storage with Hurricane Electric, FACT!!
** NanoTech is the most transparent company around and consistently Under Promises and Over Delivers, FACT!!
** NanoTech is getting nice exposure to the followers of Michael "MAYDAY" McDonald, David Huckaba, Matthew Baker and other UFC fans, FACT!!
** NanoTech's live streaming of the Legendary Band Metallica Interview was incredible, FACT!!
** NanoTech has an online store, FACT!!
** NanoGear is going to be flying out of the NanoTech store, FACT!!
** The Foley's are Geniuses, FACT!!

** NanoTech has a new Instagram account (nanotechentertainment) now, FACT!!
** Everyone wants a NanoTech T-Shirt, FACT!!
** My NanoTech (NTEK) License Plate frames are sensational, FACT!!
** NanoTech's Major Revenue will be coming from 4K Content, FACT!!
** NanoTech's Transfer Agent is ungagged, FACT!!
** NanoTech's Board Marks just keep on growing, FACT!!
** NanoTech's progress since the Shareholders Meeting in June has been astounding, FACT!!
** NanoTech has been a Growing Freak of a Company in the last year, FACT!!
** NanoTech is going to be an Absolute MONSTER in 2014, FACT!!
** The 2014 Shareholders Meeting is going to be Mind Blowing, FACT!!
** The 2014 Shareholders Meeting will be drawing a big crowd, FACT!!
** NanoTech will need to get a much larger venue for the 2014 Shareholders Meeting, FACT!!
** NanoTech is one of the few OTC companies to hold a Real Live In-Person Annual Shareholders Meeting, FACT!!
** NanoTech is a Life Changer, FACT!!
** The compilation of NanoTech DD by Nikodemos is the most massive and impressive anyone has ever seen on IHUB, FACT!!
** TRANSLATION: ANYONE can easily see that NanoTech is the REAL DEAL now, FACT!!
** NanoTech is a Once in a Lifetime Opportunity, FACT!!
** There just are NOT enough superlatives to characterize this Growing Gem, FACT!!

***** THE NEW ELITE PHARMACEUTICALS, INC (ELTP) *****

--Specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, microcapsules, granules and powders for pain, allergy, cardiovascular and infection. The Company’s primary focus has become the accelerated development of Abuse Resistant opiods

--The Company’s primary focus has become the accelerated development of Abuse Resistant opiods
-- the development of the abuse resistant technology has become their primary focus, development greatly accelerated, aggressive schedule with clinical trials

--"We have set in motion several initiatives that will have significant impact on Elite's future" CEO
-- SUCCESSFUL pilot bioequivalence study completed on 64 healthy volunteers for ELI-201, the Company's twice daily abuse deterrent oxycodone/naltrexone product.
--approaching 2 million + in revenues per quarter
--Generic Business Cash Flow Positive minus R&D costs two quarters in a row
--R&D cost have quadrupled
--Revenues Increase by 150%
--cheaper sources of API obtained
--large milestones totaling $600,000 from EPIC paid
--no over due orders all placed on time
--Poison Pill 8-A12G filed and a staggerd Board of Directors helps protect shareholders from a hostle take over, independent analyst determined the value of Elite was undervalued and its true value was between $2.10 and $2.75 in 2013
--Moving forward with ELI-154 (once a day Oxy) for Large European Market scale up
--8 launched drugs continue to gain market share
--Nasrat Hakim, Elite's President and Chief Executive Officer has agreed to provide to Elite an unsecured line of credit not to exceed $1,000,000. Proceeds will be used to support Elite's acceleration of ART product development activities.
--Board member Jerry Trepple took $600,000 repayment of his loan in preferred I shares
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development, temporary working capital, pilot studies and trials *ONLY* half used so far
--Billion dollar pipeline-33+ DRUGS including a complete line of 15 NDA and ANDA abuse resistant (ART) opiods plus multiple generics
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg ' Elite has signed a Manufacturing and License Agreement with Epic Pharma
which will have the right to manufacture, market and sell the 12 approved generics recently obtained from MIKAH. This will allow Elite to maximize their profit potential for their generic business while devoting their resources to the development of their abuse resistant products utilizing their patented proprietary technology. 2-3 of the best transferred ANDAs with minimal competion will be launched first
--first MIKAH ANDA Isradipine will be manufactured by Elite and only has 1 competitor in a 6 million dollar market, will be filed with FDA in Mar 2014
--second MIKAH ANDA Dantrolene will be made by EPIC and also has one competitor in a 12 million dollar market to be filed by June 2014
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--Partnered with CAMARGO for assistance with 505(b)(2)opportunities for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--Mega pilot trial #1 completed SUCCESSFUL 12 hr Oxy/Nal ELI-201 completed in 2013 4 way cross over on 64 voluteers. Elite going it alone so far without partner on 12 hr oxy
trial #2 A pivotal first bioequivalence(BE) study for a *second* undisclosed abuse deterrent product on going results due March 2014
trial #3 Early March 2014 3 tier study 1. snorting 2. oral abuse 3. IV abuse
trial #4 Mar/April 2014 ====$$ *Third* ART Product $$ for "once" a day (24hr)Oxy====
after BE study 3 tier study to obtain * FDA ADT LABELING *
a) snorting trial
b) oral abuse
c) IV abuse
--will be working *5-6 ART opiods* concurrently in 2014
1) Oxy/Nal twice daily ELI-216
2) Oxy/Nal once daily ELI-201
3) Mor/Nal ....(a better Embeda) new patent related
4) Undisclosed ART ( from Jan 2014 trials)

--CEO owns 23% of co. and has challenged team to get the First ART Oxycodone filed with the FDA in 2014
The 12 hr product is for a
*******2.7 Billion dollar market*******, this will pave the way for the 24 hr NDA ELI-216 Oxy/Nal which may only have to demonstrate bioequivalence to the twice a day formula or may require a Phase 3 trial, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 has 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He bought 11 million shares on the open market and takes ELTP stock as compensation. The CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued ***10X*** higher

--ELI-216 is a controlled release 24hr NDA abuse resistant oxycodone/naltrexone
--Multiple potential partners are approaching ELTP and are waiting on results of trials. CEO wants to license ART "after studies and trials completed" making it worth much more due to the steep accretion curve in the pharma field ie. the value goes up exponentially as studies are completed
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--FDA likes the pharmalogical approach to abuse resistance
--CEO, the ART is rock solid, innovative, superior and he has not seen a better ART
--1st patent for 2 bead ART 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for 2 bead ART 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection: formulation to make an existing drug abuse resistant
--3rd patent 13/863,764 is allowed for superior Embeda-like ART:
An opioid-antagonist oral dosage form which does not release a therapeutically effective amount of the opioid antagonist when the oral dosage form is orally administered to a human being, but whereby a physical alteration of the oral dosage form results in a release of the therapeutically effective amount of the opioid antagonist. An embodiment of the oral dosage form includes an opioid-antagonist layer coated onto a biologically inert pellet, and a non-releasing membrane coated onto the opioid-antagonist layer. Optionally, the oral dosage form can also include an opioid agonist, such that a method of preventing the abuse of an oral dosage form of an opioid agonist is provided by forming the oral dosage form including an opioid agonist and an opioid antagonist.
--Elites ART is modular, it can be used on ALL opiods just add a different opiod bead to the naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Woodcock & Baker strategize to add more claims

***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA and later the US Congress
--2-bead abuse resistant opiods could gradually replace some of the inferior abuse deterrent opiods now on the market

--Elite owns approx 10% of Novel Labs (Gavis Wintac): Novel and Elite have an ongoing dialog for monetization
--Novel Labs adds to Elite's value estimates for Novel's value range from 10 to 30 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--CEO and officers being paid with stock
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational
--32 employees double of two years ago
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development on the back burner
--HITK's intermediate for a generic of a branded 100 million dollar market= drug Lots produced
--Naltrexone 50mg launched Sept 2013
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of 15 abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Once the pilot and pivotal studies completed in March 2014 CEO to go on the road to present the results to viable partners
http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story?source=yahoo
http://seekingalpha.com/article/1905051-elite-pharmaceuticals-swing for-the-fences

--500 series I convertible stocks created (02/07/14) with a value of 50 million dollars. 105 were used to pay off CEO's drug transfer and Trepple's unsecured loans, 395 available IF NEEDED at a to be determined share conversion price, these can also be used for financing and leverage for a favorable deal for shareholers

--Partner Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission

Six quarters in a row of increasing revenues:

Compare Q2'13 vs Q2'12 Revenue increased +131%
Compare Q3'13 vs Q3'12 Revenue increased +30%
Compare Q4'13 vs Q4'12 Revenue increased +134%
Compare Q1'14 vs Q1'13 Revenue increased +27%
Compare Q2'14 vs Q2'13 Revenue increased +83%
Compare Q3'14 vs Q3'13 Revenue increased +154%




ELTP

WORL MIDDLE MAN
http://otcbb.com/asp/tradeact_mv.asp?SearchBy=mp&Issue=WORL&SortBy=volume&Month=1-1-2014&IMAGE1.x=18&IMAGE1.y=6

Robza73

WAFR .058 book value and Intel, Seagate and IBM are among its clients

Total assets = 15,336,296
Total liabilites = 8,361,133
O/S count = 118,639,000
book value of WAFR = .058

COREwafer Industries, Inc., through its subsidiaries, provides proprietary solutions for testing and data mining of hard drives, memory, magnetics, and other advanced semiconductor and nanotechnology devices.

WAFR acquired North East Expedite Logistics in 2011 and Core Wafer Systems, Inc. in 2012 and looks to make further strategic acquisitions if opportunity arises. In 2012 the company acquired a $10 million dollar credit line to use for growth following the filling of a S-1.

Northeast Expedite and Logistics (NEEL):
NEEL is a provider of global logistics services operating which includes a domestic service center and exclusive and non-exclusive agents.



The Company’s customers include retail and wholesale, electronics, and manufacturing companies around the world. In addition we are running trucks for the Newark Star Ledger, Washington Post, and the U.S. Postal Service.



With industrial production increasing year-over-year, the shortage of qualified drivers and trusted shipping partners is apparent in mid-markets for local deliveries. There are currently not enough trucks on the road in the North East US to service all need.



NEEL provides foundational shipping and coordination services between suppliers and destination businesses and warehouses, and we operate efficiently through cloud based tracking and E-logistics. The company is migrating into providing a fully online integrated platform as well as focusing on strategic customers for print magazines as we see a large localized need for services in this area.


Core Wafer Systems (CWS):



CWS was founded in 2001 and builds advanced test solutions for engineering and manufacturing to verify devices are being made correctly.



CWS revenue is expected to skyrocket over the next 4 years due to increased for faster testing equipment as fabrication facilities upgrading aging and damaged hardware. The entire semiconductor testing market is expected to exceed $10 billion in 2012!



Its customers include powerhouses like Western Digital, Seagate, Intel, TI, TSMC, Fujitsu, IBM, ON Semiconductor, HP, SEMATECH, and Toshiba.



“WAFR has two profitable subsidiaries and estimates $14M revenue for 2012 with additional LOI from Western Digital and Seagate for $50M upon delivery of a new product currently in initial testing phase. With a $10 million dollar line of credit in-place the company is positioned for growth beyond 2012,” stated Lt. General Thomas Stafford (NASA), Chairman of the Board.

WAFR provides foundational shipping and services between suppliers and destination businesses and warehouse throughout the North East USA and Canada. The company operates efficiently through E-logistics.

WAFR builds proprietary software that monitors and analyzes data generated during the testing semiconductor components such as computer chips, memory, and miniature electronic components. The company can enable manufacturers to conduct tests up to 60 times faster than its competitor. WAFR solution is installed within 95% of the fabrication facilities throughout the world.

The major purpose of Patent Application 13/863,764 "Abuse-Resistant Oral Dosage Forms And Method Of Use Thereof" puts a complete lock on the co-polymer Eudragit equivalent composition and wt% range, which thereby provides superior duration of its antagonist sequestering acrylic polymer against leakage for normal intake. While 24 Hrs is the prime time duration to measure the sequestering polymer leak rate, there is no doubt IMO, although not mentioned except as 24Hrs and beyond, that the pH Independent sequestering polymer with its 15 to 80% wt range is designed to minimize leakage across 3 days or 72 hrs which would best cover OIC (opioid-induced constipation).

References provided as follows:

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20130230596.PGNR.&OS=DN/20130230596&RS=DN/20130230596


Quote:
1. A pellet comprising: a biologically inert pellet; an opioid-antagonist layer coated on the biologically inert pellet, wherein the opioid-antagonist layer comprises a therapeutically effective amount of an opioid antagonist; and a non-releasing membrane coated on the opioid-antagonist layer, wherein the non-releasing membrane comprises a water-retardant polymer that is a EUDRAGIT.RTM. NE 30D or NE 40D non-ionic poly(ethyl acrylate-co-methyl methacrylate), wherein the at least one water-retardant polymer constitutes about 42% to about 50% by weight of the solids content of the oral dosage form.

[0029] The non-releasing membrane of the invention comprises a water-retardant polymer, such as, for example, an alkyl cellulose, an acrylic acid polymer, an acrylic acid copolymer, a methacrylic acid polymer, a methacrylic acid copolymer, shellac, zein, or hydrogenated vegetable oil. The water-retardant polymer is physiologically acceptable, and it substantially prevents the release of the opioid antagonist. In addition, the water-retardant polymer could optionally be water insoluble. A preferred water-retardant polymer is a poly(meth)acrylate polymer, such as Eudragit NE 30 D or Eudragit NE 40 D, or a combination thereof Most preferably, the water-retardant polymer comprises the poly(meth)acrylate polymer, Eudragit NE 30 D. Eudragit NE 30 D and Eudragit NE 40 D polymers are available from Rhom Pharma, D-6108 Weiterstadt 1, Dr. Otto-Rohm-Str. 2-4, Germany. Eudragit NE 30 D and Eudragit NE 40 D are pH independent polymers available as 30% or 40% aqueous dispersions, respectively. Furthermore, Eudragit RS 30 D, Eudragit RL 30 D, Eudragit S and Eudragit L 30 D are further examples of suitable water-retardant polymers. When employing Eudragit NE 30 D as the water-retardant polymer, the NE3OD solids in the non-releasing membrane generally constitute about 15% to about 80% of the total weight of the solids content of the final oral dosage form, preferably about 25% to about 60%, and most preferably about 30% to about 50% of the total weight of the solids content of the final oral dosage form.

[0021] The invention provides an oral dosage form which does not release a therapeutically effective amount of an opioid antagonist when the oral dosage form is orally administered to a human being. That is, the oral dosage form of the invention is designed such that when orally administered to a human being, it would not provide effective blood levels of the opioid antagonist for up to about twenty-four (24) hours and beyond, at which time the opioid agonist would have previously been released and would have had its intended analgesic effect on the human being.

eli-201
ELI-201
eli201
ELI201

***** THE NEW ELITE PHARMACEUTICALS, INC (ELTP) *****

--Specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, microcapsules, granules and powders for pain, allergy, cardiovascular and infection. The Company’s primary focus has become the accelerated development of Abuse Resistant opiods

-- the development of our abuse resistant technology has been greatly accelerated, aggressive schedule with clinical trials startd Dec 5, 2013.
--"We have set in motion several initiatives that will have significant impact on Elite's future" NH
-- pilot bioequivalence study initiated in healthy volunteers for ELI-201, the Company's twice daily abuse deterrent oxycodone/naltrexone product.
--averaging 1 million + in revenues per quarter
--Generic Business Cash Flow Positive minus R&D costs for ART opiods
--R&D cost have quadrupled
--Revenues Increase by 83%
--large milestone payment from EPIC paid Nov 15, 2013
--no over due orders
--inventory $ 1.7 million
--Poison Pill 8-A12G filled to protect shareholders from a hostle take over of Elite
--Moving forward with ELI-154 (once a day Oxy) for Large European Market scale up
--8 launched drugs continue to gain market share
--Nasrat Hakim, Elite's President and Chief Executive Officer. Pursuant to this agreement, Mr. Hakim has agreed to provide to Elite a line of credit not to exceed $1,000,000. Proceeds will be used to support Elite's acceleration of product development activities.
--Board member Jerry Trepple loaned the co. 1 million dollars unsecured $600k used so far may take stock as repayment of loan
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development, temporary working capital, pilot studies and trials *ONLY*

--Billion dollar pipeline-33 DRUGS plus a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg ' Elite has signed a Manufacturing and License Agreement with Epic Pharma
which will have the right to manufacture, market and sell the 12 approved generics recently obtained from MIKAH. This will allow Elite to maximize their profit potential for their generic business while devoting their resources to the development of their abuse resistant products utilizing their patented proprietary technology. 2-3 of the best transferred ANDAs with minimal competion will be launched in 2014

$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--CAMARGO helping with 505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--12 hr oxycodone/naltrexone ELI-201 with 2 bead ART trials initiated
--Clinical trial #1 12 hr ELI-201 Dec 05, 2013 4 way cross over Elite going it alone without partner on 12 hr oxy
trial #2 A pivotal bioequivalence study for a *second* abuse deterrent product begins Jan 10, 2014
trial #3 Early March 2014
trial #4 Mar/April 2014 ====$$ *Third* ART Product $$ for "once" a day (24hr)Oxy====
--will be working *3-4 ART opiods* concurrently in 2014 possibly more undisclosed
==CEO has challenged team to get the First ART Oxycodone filed with the FDA in 2014
The 12 hr product is for a
*******2.7-3.0 Billion dollar market*******, this will pave the way for the 24 hr NDA ELI-216 Oxy/Nal which will only have to demonstrate bioequivalence to the twice a day formula, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 has 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He bought 11 million shares on the open market and takes ELTP stock as compensation. The CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued ***10X*** higher

--ELI-216 is a controlled release 12 and 24hr NDA abuse resistant oxycodone/naltrexone 24 hr version requires Phase III clinical trials
--Multiple potential partners are approaching ELTP and are waiting for human data gathered (multiple short studies required) then discuss results with FDA. CEO wants to license ART "after studies and trials completed" making it worth much more due to the steep accretion curve in the pharma field ie. the value goes up exponentially as studies are completed
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--FDA likes the pharmalogical approach to abuse resistance JT
--Hakim, the ART is rock solid, innovative, superior and he has not seen a better ART
--1st patent for 2 bead ART 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for 2 bead ART 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection pending
--Elites ART is modular, not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies Nov/Dec
2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 2013
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn & Woodcock strategize to add more claims

***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA and later the US Congress
--2-bead abuse resistant opiods could gradually replace some of the inferior abuse deterrent opiods now on the market

--Elite owns approx 10% of Novel Labs (Gavis Wintac): Novel and Elite have an ongoing dialog for monetization
--Novel Labs adds to Elite's value estimates for Novel's value range from 10 to 30 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--CEO and officers being paid with stock
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational
--30 employees double of two years ago
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development on the back burner
--HITK's intermediate for a generic of a branded 100 million dollar market= drug Lots produced
--first of 8 Epic drugs(Stategic Epic Alliance) ISRAPIDINE has been filed with the FDA ONLY ONE COMPETITOR
--Naltrexone 50mg launched Sept 2013
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Rodman Renshaw GLOBAL Investing Conference presentation http://www.earningsimpact.com/Transcript/83582/ELTP/Elite-Pharmaceuticals---Rodman-and-Renshaw-Annual-Global-Investment-Conference/Page/1#sthash.QxtYt3CJ.dpbs and several Seeking Alpha articles
http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story?source=yahoo

--Right Place at the Right Time with the Right Products Jerry Treppel
--On September 10, 2012, Epic Investments exercised the remaining Series E Convertible Preferred Stock. Pursuant to the terms of the Series E Convertible Preferred Stock, 65,843,621 shares of common stock were issued to Epic Investments upon the conversion.

--Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission

Compare Q2'13 vs Q2'12 Revenue increased +131%
Compare Q3'13 vs Q3'12 Revenue increased +30%
Compare Q4'13 vs Q4'12 Revenue increased +134%
Compare Q1'14 vs Q1'13 Revenue increased +27%
Compare Q2'14 vs Q2'13 Revenue increased +83%

Revenues from Manufacturing: Q2 '14 $921k!!!


ELTP

http://illiweb.com/fa/i/smiles/lol.gif

***** THE NEW ELITE PHARMACEUTICALS, INC (ELTP) *****

--Specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, microcapsules, granules and powders for pain, allergy, cardiovascular and infection. The Company’s primary focus has become Abuse Resistant opiods

--Billion dollar pipeline-33 DRUGS plus a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg ' Elite has signed a Manufacturing and License Agreement with Epic Pharma
which will have the right to manufacture, market and sell the 12 approved generics recently obtained from MIKAH. This will allow Elite to maximize their profit potential for their generic business while devoting their resources to the development of their abuse resistant products utilizing their patented proprietary technology.

--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 has 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He bought 11 million shares on the open market and takes ELTP stock as compensation. The CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued ***10X*** higher

--Doug Plassche appointed Vice President of operations to run manufacturing and to lead the operational initiatives of the Company as it expands its product pipeline. Mr. Plassche has a proven track record in all critical areas including quality, compliance, process, operations, planning and personnel development. He oversaw 450 employees previously at Activas

--cash flow positive an ELTP goal for this fiscal year(ending Mar 31, 2014)
--8 launched drugs continue to gain market share
--Nasrat Hakim, Elite's President and Chief Executive Officer. Pursuant to this agreement, Mr. Hakim has agreed to provide to Elite a line of credit not to exceed $1,000,000. Proceeds will be used to support Elite's acceleration of product development activities.
--Board member Jerry Trepple loaned the co. 1 million dollars unsecured $600k used so far may take stock as repayment of loan
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development, temporary working capital, pilot studies and trials *ONLY*
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--12 hr oxycodone/naltrexone with 2 bead ART beginning a 6 month long 38 person trial Nov/Dec 2013 for a
*******2.7-3.0 Billion dollar market*******, this will pave the way for the 24 hr NDA ELI-216 Oxy/Nal which will only have to demonstrate bioequivalence to the twice a day formula, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

--ART Oxy/Nal is a priority with Elite and further along than most people think, JT
--ELI-216 is a controlled release 24 hr NDA abuse resistant oxycodone/naltrexone requiring Phase III clinical trials
--Multiple potential partners are approaching ELTP and are waiting for human data gathered (multiple short studies required) then discuss results with FDA. CEO wants to license ART after studies and trials completed making it worth much more due to the steep accretion curve in the pharma field ie. the value goes up exponentially as studies are completed
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--FDA likes the pharmalogical approach to abuse resistance JT
--Hakim, the ART is rock solid, innovative, superior and he has not seen a better ART
--1st patent for 2 bead ART 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for 2 bead ART 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection pending
--Elites ART is modular, not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies Nov/Dec
2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 2013
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn & Woodcock strategize to add more claims

***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA and later the US Congress
--2-bead abuse resistant opiods could gradually replace some of the inferior abuse deterrent opiods now on the market

--Elite owns approx 10% of Novel Labs (Gavis Wintac): Novel and Elite have an ongoing dialog for monetization
--Novel Labs adds to Elite's value estimates for Novel's value range from 10 to 30 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--CEO and officers being paid with stock
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational
--30 employees double of two years ago
--Nasarat brings 13 new ANDA drugs many requiring only CBE 30 review for transfer
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development
--HITK's intermediate for a generic of a branded 100 million dollar drug
--first of 8 Epic drugs due out anytime(from the Stategic Epic Alliance)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--Naltrexone 50mg launched Sept 2013
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Rodman Renshaw GLOBAL Investing Conference presentation http://www.earningsimpact.com/Transcript/83582/ELTP/Elite-Pharmaceuticals---Rodman-and-Renshaw-Annual-Global-Investment-Conference/Page/1#sthash.QxtYt3CJ.dpbs and several Seeking Alpha articles
http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story?source=yahoo

--Right Place at the Right Time with the Right Products Jerry Treppel
--On September 10, 2012, Epic Investments exercised the remaining Series E Convertible Preferred Stock. Pursuant to the terms of the Series E Convertible Preferred Stock, 65,843,621 shares of common stock were issued to Epic Investments upon the conversion.

Camargo

ELTP

http://www.garagedoorremotesandpartsusa.com/products/search/index/page:2/industry:1/product_category:5/manufacturer:17

ABUSE DETERRENT OXYCODONE ELITE PHARMACEUTICALS ELTP

--Specializes in the development of oral controlled release products, such as delayed, sustained, targeted and pulsatile release tablets, pellets, capsules, microcapsules, granules and powders for pain, allergy, cardiovascular and infection. The Company’s primary focus has become Abuse Resistant opiods

--Billion dollar pipeline-33 DRUGS plus a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--20 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg including 12 new ones from MIKAH many only needing CBE30 review for quick transfer with some having markets with very limited competition. They will concentrate on the best 3-4 MIKAH ANDA's with the largest potential markets

--Nasarat Hakim former VP of Activas appointed president and CEO of Elite 08-05-13 has 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He brings with him proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He is making ART priority one. He bought 11 million shares on the open market and takes ELTP stock as compensation. The CEO noted, we are trading on our financials(revenues) and if we had no revenue we would be trading on ART and R&D and we would be valued ***10X*** higher

--Doug Plassche appointed Vice President of operations to run manufacturing and to lead the operational initiatives of the Company as it expands its product pipeline. Mr. Plassche has a proven track record in all critical areas including quality, compliance, process, operations, planning and personnel development. He oversaw 450 employees previously at Activas

--cash flow positive an ELTP goal for this fiscal year(ending Mar 31, 2014)
--8 launched drugs continue to gain market share
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development, temporary working capital, pilot studies and trials *ONLY*

$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
--12 hr oxycodone/naltrexone with 2 bead ART beginning a 6 month long 38 person trial Nov/Dec 2013 for a
*******2.7-3.0 Billion dollar market*******, this will pave the way for the 24 hr NDA ELI-216 Oxy/Nal which will only have to demonstrate bioequivalence to the twice a day formula, CEO commented that a conservative 20% of that market would get us ****$4.00-$5.00 PPS**** with just their first ART opiod
$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

--ART Oxy/Nal is a priority with Elite and further along than most people think, JT
--ELI-216 is a controlled release 24 hr NDA abuse resistant oxycodone/naltrexone requiring Phase III clinical trials
--Multiple potential partners are approaching ELTP and are waiting for human data gathered (multiple short studies required) then discuss results with FDA. CEO wants to license ART after studies and trials completed making it worth much more due to the steep accretion curve in the pharma field ie. the value goes up exponentially as studies are completed
--ART Oxy/Nal is a priority with Elite and further along than most people think, JT
--ELI-154 24 hr ER oxy (w/o ART) still in scale up for the European market
--FDA likes the pharmalogical approach to abuse resistance JT
--Hakim, the ART is rock solid, innovative, superior and he has not seen a better ART
--1st patent for 2 bead ART 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for 2 bead ART 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection pending
--Elites ART is modular, not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies Nov/Dec
2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 2013
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn & Woodcock strategize to add more claims

***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA and later the US Congress
--2-bead abuse resistant opiods could gradually replace some of the inferior abuse deterrent opiods now on the market

--Elite owns approx 10% of Novel Labs, Gavis and recently Wintac: Novel and Elite have an ongoing dialog for monetization a lot goes into determining the value of a private co.
--Novel Labs adds to Elites value estimates for Novel's value range from 10 to 50 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--Novel has provided to the Company, copies of its prior year tax returns and management prepared forecasts showing growing revenues
--CEO and officers being paid with stock
--Former CEO Jerry Trepple loaned the co. 1 million dollars unsecured $600k used may take stock as repayment of loan
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational
--30 employees double of two years ago
--Nasarat brings 13 new ANDA drugs many requiring only CBE 30 review for transfer
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--Acend Labs has new contracts for methadone
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development
--HITK's intermediate for a generic of a branded 100 million dollar drug
--first of 8 Epic drugs due out anytime(from the Stategic Epic Alliance)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough
--Naltrexone 50mg launched Sept 2013
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials with
--undisclosed 100% Elite owned ANDA approx 1 year
--Elite's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO
--ELTP visibility increasing: Rodman Renshaw GLOBAL Investing Conference presentation http://www.earningsimpact.com/Transcript/83582/ELTP/Elite-Pharmaceuticals---Rodman-and-Renshaw-Annual-Global-Investment-Conference/Page/1#sthash.QxtYt3CJ.dpbs and several Seeking Alpha articles
http://seekingalpha.com/article/1688112-elite-pharmaceuticals-call-it-a-comeback-story?source=yahoo

--Right Place at the Right Time with the Right Products Jerry Treppel
--On September 10, 2012, Epic Investments exercised the remaining Series E Convertible Preferred Stock. Pursuant to the terms of the Series E Convertible Preferred Stock, 65,843,621 shares of common stock were issued to Epic Investments upon the conversion.

--Right Place at the Right Time with the Right Products CEO
--Billion dollar pipeline made up of a complete line of NDA and ANDA abuse resistant (ART) opiods and multiple generics
--8 FDA approved drugs: hydromorphone, phentermine 37.5 mg, lodrane D, methadone, phendimetazine, phentermine 15mg, phentermine 30mg, naltrexone 50mg
--4th quarter 2013 1.5 million in revenues best in co. history
--cash flow positive (CFP) this quarter, not including R&D cost, the Board of Directors making break even operations essential
--Manufacturing revenue for the 4th quarter(2013 fisical) totals $969 for an increase of $569K, or 142% from the previous quarter.
Royalty & Lic. revenue for the 4th quarter(2013) totals $368 for an increase of $212K, or 135% from the previous quarter.
Lab fee revenue for the 4th quarter totals $187 for an increase of $76K, or 68% from the previous quarter.
--launched drugs continue to gain market share
--$10 Million equity line of funding secured from Lincoln Capital Fund (LPC) 04/22/2013 for product development only, temporary working capital, pilot studies and trials used $320k so far
--600 % increase in market cap in 2 years
--out standing shares 374K
--ELI-154 24 hr ER oxy (w/o ART) still in scale up will be sold on the European market looking for a partner
--12 hr oxycodone with ART starting pilot studies calendar 2013 for a 3 Billion dollar market will pave the way for the once a day which will only have to demonstrate (prove) bioequivalence to the twice a day formula
--ELI-216 is a controlled release 24 hr NDA abuse resistant(ART) oxycodone requiring Phase III clinical trials
--a partner for commercialization of ELI-216 will be done once human data gathered(multiple short studies required) then discuss with FDA JT wants to license after studies and trials complete making it worth much more due to the steep accretion curve in the pharma field
--ELI-216 is a priority with Elite and further along than most people think, per CEO
--FDA likes the pharmalogical approach to abuse resistance per CEO
--1st patent for ELI-216 8/182,836 abuse resistant oral formulations and method of use thereof (approved May 22, 2012) method for making an abuse resistant drug
--2nd patent for ELI-216 8/425.933 formerly 12/640,344 (04/23/2013) combined with first patent, gives Elite 20 years of propietary protection on their 2 bead ART: formulation to make an existing drug abuse resistant
--patent 13/863,764 Child Continuity Data strengthens Elite's patent protection of 2-bead ART giving it triple patent propietary protection
--2-bead abuse resistant opiods could replace the inferior abuse deterrent(easily defeated) opiods now on the market
--Elites ART is modular (plug and play system), not for just oxycodone it can be used on ALL opiods just add a different opiod bead to the standard sequestered naltrexone bead
--NE 30 polymer for sequestering naltrexone was found to be far superior to other polymers
--Elite has advanced the development of this technology(twice/day) through commercial scale up 05-2013
--The Company expects their first commercially scaled-up, abuse-resistant opioid(twice daily) product to enter human pilot studies late calendar 2013, Work has also been conducted on another abuse-resistant opioid product(once/day)
--Elite may license these ART products at a later date to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for the product.
--BE and PK studies for ART progressing, some will complete in 2013
--Patent pending 13/379,481 microtablets for use with Elite's abuse resistant products
--Patent pending 13/379,486 microtablets 0.25-1.0mm, smallest in the industry for use with ALL medicines
--patent 12/075,816 for Sequestering polymer acrylic co-polymer composition: ON HOLD while Elite and lawyers Washburn & Woodcock strategize to add more claims

***The recent guidances and actions by the FDA related to extended release opioids and specifically oxycodone demonstrates the FDA support for abuse resistant technologies
Opioid products incorporating abuse resistant technologies have become a public health priority and these recent actions appear to be a major step towards the FDA eventually requiring that all extended release opioids utilize these technologies.
January 9, 2013, the FDA released its new draft guidance document, titled "Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling". The document discusses what it will take for an opioid formulation to secure an abuse resistant label. The implications for companies that meet these expectations are significant and even more so for those that meet these requirements and have patented abuse resistant technologies.
March 2013, 48 state attorney generals called on the agency to require generic makers to produce tamper-resistant versions of opioid medicines
--the STOPP ACT - a bill before Congress NOW, introduced by US Rep's Rahall, Rogers and Keating. The law will prohibit any old-formula opiod from entering the market if the FDA has an equivalent abuse deterrent/resistant opiod approved
--CLADD petitions FDA to reject all opiods without ART
--FDA's Purdue ruling April 16, 2013 : prohibits new original non-abuse resistant oxycodone from being made in generic form, unless it has an abuse deterrent/resistant properties. FDA will not accept or approve any ANDA applications based on the original OxyContin formulation
--the FDA decision basically requires generic companies to buy or develop their own abuse deterrent/resistant technology: it effectively eliminates much of Elite's competition which has no ART thus making Elite's 2-bead ART MORE VALUABLE
--going foward all new generic and probably NDA branded opiods will be required to have Abuse deterrent/resistant properties
--May 10, 2013 Endo Health (ENDP) ruling
--Elite's Competition being taken out one by one by the FDA
1) Pfizer PFE
2) Endo Health ENDO
3) Pain Therapeutics PTIE
4) Acura Pharma ACUR
5) Durect Corp DRRX

--Elite owns approx 10% of Novel Labs, Gavis and recently Wintac: Novel and Elite have an ongoing dialog for monetization a lot goes into determining the value of a private co.
--Novel Labs adds to Elites value estimates for Novel's value range from 10 to 50 million dollars CEO admits value is worth more than their initial investment
--There are accordingly a total of 30+ products including a generic morning after (PLAN B) pill currently identified as being approved/marketed by Novel and Gavis, with such total representing an increase of 4 products as compared to a comparable point in the prior year
--Novel has provided to the Company, copies of its prior year tax returns and management prepared forecasts showing growing revenues
--CEO and officers being paid with stock
--CEO Jerry Trepple loaned the co. 1 million dollars unsecured (non-dilutive) 600k used considering taking stock as repayment of loan
--CSO of Elite is Epics president and works for shares of ELTP
--VP @ Actavis/Mikah is a special consultant to EPIC
--COO President Chris Dick replacement will be an expert in 505 b2 development per the CEO
--multiple partners have no concerns: Watson/Actavis, Mikah, Epic, TAGI, The Pharm Network, ECR, Precision Dose, Celgene Corp, TPN/Ascend, Novartis, SmithGlaxoKlein and the undisclosed Hong Kong Pharma
--minimal debt 3.5 million
--New Jersey(NJEDA) tax credits
--contracting deals with other pharmas
--TWO 15,000 sq/ft FDA-DEA-cGMP registered manufacturing labs for research, development and manufacturing from concept to commercialization
--NEW packaging line operational and adding revenue to the bottom line by making and saving the co. money
--29 employees double of two years ago with yet another opening
--4 drugs in * SCALE UP *
--phentermine 15 & 30mg launched (April 11, 2013) is competing with Qsymia(phentermine and topiramate)
--current API supplier for phentermine has reduced its cost thus increasing profitability and making product more competitive
--Acend Labs has new contracts for methadone
--hydromorphone best quarter ever(ending Mar 31, 2013)
--Hong Kong Pharma NDA development over a year to go
--MIK-001 505b2 NDA maybe an improved Embeda on schedule in development
--HITK's intermediate for a generic of a branded 100 million dollar drug
--first of 8 Epic drugs due out anytime(from the Stategic Epic Alliance)
--505(b)(2)opportunities's for 12 hr ART generics and NDA's where Bio-equivalency studies alone are enough (no phase III)
--Naltrexone FDA approved, launch pending (July-Aug 2013) production began late June 2013
--citizens petition with FDA for 100% owned ANDA 12hr ext release brompheniramine pseudophedrine (Drixoral equivalent) antihistamine/decongestant to compete with Avanthi Inc generic
--Lodrane 24D equivalent waiting on feed back from FDA they will tell them which pseudoephedrine salt to use and which product to use to run trials against
--undisclosed 100% Elite owned ANDA approx 1 year
--CEO's goal is to commercialize a COMPLETE LINE of abuse resistant opiods
--Uplisting to the NASDAQ exchange per the CEO, IR indicating ASAP, may include RS with blockbuster launch partner so to maintain PPS
--CEO obligated to look at ALL buy out offers obligated to maximize shareholder value


ELTP

So we know who Epic and Mikah are, but who is Elite Pharmaceuticals? Elite is a little company that's been around a long time. And their specialty and focus? Extended release and abuse resistant opioids. And they have already passed an Oxycontin product (a once a day Oxycontin) through both Phase 1 and Phase 2 trials and seem to looking for a partner to go into Ph3 based on conference call transcripts. Also seems they are looking more at abuse resistant generic opioid products that they will manufacture for themselves. The company's website identities these products as in "scaleup". The CEO noted on a recent PR they were about ready to enter studies for at least one product. Also just so happens that the Chief Scientific Officer at Elite Pharmaceuticals developing these formulations is none other than the President of Epic.

Elite has 8 approved FDA drugs but two of them are what ties this together. Hydromorphone, an often abused opioid known as Dilaudid and Naltrexone the key antagonist noted above in Embeda. And where did these two products and ANDA applications come from? Turns out that they came from Mikah Pharmaceuticals originally from Actavis Totowa in trade for some cash and R&D work. And as part of the Naltrexone agreement, Elite and Mikah signed a deal to develop a 505B2 NDA identified as MIK001. Elite would also contract manufacture this product for Mikah. The 505B2 pathway is the likely requirement for drug submission and approval by the FDA for abuse resistant opioid formulations of current opioid products. And what is Elite's technology and IP based on? The antagonist (Naltrexone) and agonist (opioid) approach. They received two patents in the past year for this technology and formulation capability and have others pending.

While the Embeda concept described above is to put both the Naltrexone and Opioid on the same bead, Elite uses their patented formulation to sequester the Naltrexone using multiple beads, identical looking and indistinguishable except one carries the opioid and one carries the antagonist. The company has put over 100 million dollars into their R&D over the years and you have probably never heard of them.

So where might Actavis get its IP and technology? It would seem that they already have at least one partner in this business, with patent protection using the agonist/antagonist approach similar to Embeda. Remember this article, I am betting that you hear more about these relationships in the future. Actavis, Epic, Mikah, Elite...

--------------------------------------------------------------------------------

FROM LASER

We know who Epic and Mikah are, but who is Elite Pharmaceuticals? Elite is a little company that's been around a long time. And their specialty and focus? Extended release and abuse resistant opioids. And they have already passed an Oxycontin product (a once a day Oxycontin) through both Phase 1 and Phase 2 trials and seem to looking for a partner to go into Ph3 based on conference call transcripts. Also seems they are looking more at abuse resistant generic opioid products that they will manufacture for themselves. The company's website identities these products as in "scaleup". The CEO noted on a recent PR they were about ready to enter studies for at least one product. Also just so happens that the Chief Scientific Officer at Elite Pharmaceuticals developing these formulations is none other than the President of Epic.

Elite has 8 approved FDA drugs but two of them are what ties this together. Hydromorphone, an often abused opioid known as Dilaudid and Naltrexone the key antagonist noted above in Embeda. And where did these two products and ANDA applications come from? Turns out that they came from Mikah Pharmaceuticals originally from Actavis Totowa in trade for some cash and R&D work. And as part of the Naltrexone agreement, Elite and Mikah signed a deal to develop a 505B2 NDA identified as MIK001. Elite would also contract manufacture this product for Mikah. The 505B2 pathway is the likely requirement for drug submission and approval by the FDA for abuse resistant opioid formulations of current opioid products. And what is Elite's technology and IP based on? The antagonist (Naltrexone) and agonist (opioid) approach. They received two patents in the past year for this technology and formulation capability and have others pending.

While the Embeda concept described above is to put both the Naltrexone and Opioid on the same bead, Elite uses their patented formulation to sequester the Naltrexone using multiple beads, identical looking and indistinguishable except one carries the opioid and one carries the antagonist. The company has put over 100 million dollars into their R&D over the years and you have probably never heard of them.

So where might Actavis get its IP and technology? It would seem that they already have at least one partner in this business, with patent protection using the agonist/antagonist approach similar to Embeda. Remember this article, I am betting that you hear more about these relationships in the future. Actavis, Epic, Mikah, Elite...

--------------------------------------------------------------------------------

FROM LASER

OK, thought is was odd that there was some volume and a fairly recent post after 6 years of nada.

This has nothing to do with Surgilight. I shorted surgi from $20.00 to the bottom best investment ever. I haven't heard anything out of them in years. in BK court in new york last I heard. Biolase I think has the licence to presbyopia reversal laser tech which I found intriguing . Im watching that to see if they ever do anything with it.

Was this posted here by accident or is it relevant to this ticker? I just noticed the volume here today and noticed one recent post. TIA

Oxycontin- Purdue 2010 version - oxycodone provides only an incremental advantage over the very original oxycontin per the FDA
Oxecta- pfizer/King(PFE)/Acura Pharma(ACUR) - oxycodone
Acurox- King/Acura Pharma(ACUR) oxycodone / niacin
Opana ER - Endo HEALTH(ENDO) - oxymorphone 2012 ver
Exalgo - MALLINCKRODT, INC - hydromorphone
Embeda- Pfizer/King(PFE) - morphine / naltrexone - recalled for stability issues
Remoxy- Pfizer/King(PFE) Pain Therapeutics (PTIE) Durect Corp(DRRX) - oxycodone ER struggling needs additional clinical studies manufacturing issues NO COMPETITION
Deterx- Collegium- oxycodone ER

Suboxone- Reckitt-Benckiser(RBGPF) - sublingual buprenorphine / naloxone



ALO-01 Pfizer morphine/naltrexone recall unstable
ALO-02 Pfizer oxycodone/naltrexone
Acuracet- Acura- oxycodone/acetaminophen Aversion Technology
Vycavert-Acura- hydrocodone acet




http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3411218/

YEAH - Finally some news!! Doesn't mention Surgilight directly but does does praise LAPR. Surgilight may rise like the phoenix.

http://www.osnsupersite.com/view.asp?rID=21717