I think Feuerstein’s Satraplatin article is partially right.
Right: that Satraplatin’s commercial uptake will be problematic if it does not show a survival benefit in the final analysis and that the EMEA might request more evidence of efficacy than the FDA.
Wrong: that the subset analysis cited by Feuerstein could derail FDA approval.
FDA approval is a shoo-in, IMO, because the trial had an SPA and it hit the primary endpoint with flying colors. It makes no difference that Satra did worse than controls on the small death component of the PFS composite. Nor does it matter that the pain component of the PFS composite was the only component to achieve statistical significance; in fact, it would have been surprising if statistical significance had been attained on several of these components because there weren’t enough events within each component to expect such an outcome.
For Feuerstein to say that Satra may affect only pain and not survival is premature, IMO; I know of no MoA explanation of why this should be true. Let’s wait to see what the actual survival data show.
p.s. I have not seen the “separate analysis” that Feuerstein referred to, but I don’t think I need to.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
