Basically then it boils down to one trial with unimpeachable Significance and a smaller one with an unimpeachable Trend.
And the smaller one seems to have some population bias.
Substantial Evidence for Clinical Benefit ? I think Yes on balance.
Ergo .............. I think we will enjoy both the Dance and the Party too.
One Caveat - the Questions - the Votes are almost a footnote; I would say the FDA is reserving its Rights if the vote can be termed inconclusive at all. But what's on their mind ?
>The most interesting part is that the Statistical Review makes it very clear that the exact form of the Cox Regression model was NOT prespecified.<
Not only was it not prespecified (despite what mitch said), DNDN never gave the impression that the Cox analysis was done on something other than an ITT population. We now know that ~10% of the patients were thrown out, in a manner that was favorable to the provenge arm.
Deception in biotechs is, sadly, the rule rather than the exception.
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