Re: DNDN skepticism
>By posting this article on DNDN, it may save Dew digging up some of the many posts on this board summarizing skepticism about the prospects for Provenge based on data make public so far.<
I agree with the MF author that DNDN’s BLA is high-risk, but that’s the extent of my agreement.
My skepticism of the BLA is based on, but not limited to, the following:
1. 9901 by itself cannot possibly be sufficient for approval. It if were, DNDN would have filed a BLA when the 9901 data were mature.
2. Thus, the key question is whether 9902a is sufficiently supportive of 9901 to warrant approval based on one successful study and one supportive study. My contention is that 9902a is not supportive because the raw p-value for overall survival was 0.33 and the Cox analysis that lowered the p-value to 0.02 was not fully pre-specified.
3. As further evidence that the Cox analysis of 9902a is data mining, I note that: a) DNDN has never completely clarified for investors exactly how the Cox analysis was conducted; and b) DNDN did not begin to talk about Cox at all until around the time when the 9902a survival data matured.
4. Changing the 9902b protocol to make Cox the primary endpoint supports the contention in item #3 above and makes 9902b the real pivotal study, in my view. (I.e., DNDN learned ex post facto that Cox gave a good result in 9902a and hence they are testing this Cox endpoint prospectively in 9902b. This is how things are supposed to be done.)
5. The slowness of the BLA submission—16 months from the time that the final 9902a were reported until the last BLA module was filed—suggests to me that DNDN was in no hurry to get the BLA done because they themselves do not expect approval on the first review cycle.
6. DNDN slashed the capacity of the manufacturing output by 75%, giving further credence to the view that management itself is somewhat bearish about approval on the first review cycle.
7. The argument that DNDN could not expedite the BLA because manufacturing buildout was the rate-limiting step does not ring true because the slowness of the manufacturing buildout was a policy decision by DNDN itself.
8. Last but not least, DNDN’s senior management behaved during 2005 and 2006 as though this is a company to run away from. At least 75% of senior management has turned over during this period, including not just one but two CFOs. I consider CFOs the “canaries in the mine” because they, among all senior executives, have the most to lose by sticking with a loser.
Dew
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
