"second phase 3 showed more people died" I would have to study actimune to know whether there is any similarity. What DNDN filed and got rejected imo constitute the mother of all proof of concept study for both efficacy and safety. Even Scher himself would not believe there would be a total reversal of treatment effect and that 9902b shows provenge would kill patients off.
The crux for the provenge rejection- was the entire oncology community did not know how it worked, but not whether it worked. The statistical technicality was simply a pretense.
Questions to the MD's on board- how much do you really care about type I error b/c OS was not the primary endpoint? If Satraplatin could show a significant PFS with a 150-subject trial instead of a humongous 900-subject one, would you not jump up and down and approve it?
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