p3analyze............
I don't think TTP is the issue, because they are not filing on TTP - if you go back a year in the press releases, you can read that the NDA filing will be all about Survival.
I am pretty sure that I have seen a label or two for "bioequivalent" drugs where the primary endpoint was just non-inferiority. The label states that clinical trials proved just that, non-inferiority. However if you look at the tabulated data, you can see also that they hit the p-value for superiority (over the related drug on the control arm).
The result is that they cannot market the drug for superiority; neverthless a discerning eye can readily see the proof of exactly that. Of course then "word-of-mouth" helps over time.
Back to DNDN: I don't think it matters a whole lot as long as Provenge gets approved. Certainly the NDA is to be filed upon the axiom of a Survival Benefit, and perhaps if that's accepted by ODAC/CBER plus the FDA, that's exactly what the label can openly claim. Now an after-thought - is it possible that Dr Gold has stated that he is looking for a survival label ? Me thinks maybe he did.
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