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Re: DewDiligence post# 3531

Sunday, 05/13/2007 11:21:50 PM

Sunday, May 13, 2007 11:21:50 PM

Post# of 12660
<The p-values you cite for 9901 and 9902a are based on cherry-picked Cox analyses. In 9902b, the primary endpoint will be based on a Cox analysis that is fully pre-specified.>

"cherry-picked" is hard given that the FDA statisticians also tried a few other models that showed stat sig or trended toward stat sig. However, the large p-value improvement from log-rank to Cox might not repeat with the same magnitude in D9902b. The trial size is much larger, hence less chance for imbalances. Also, it sounded like they are stratifying for bone met count which was heavily imbalanced against Provenge so Cox was effective.

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