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Re: Biowatch post# 49678

Sunday, 07/15/2007 1:14:19 PM

Sunday, July 15, 2007 1:14:19 PM

Post# of 252426
<<The p values quoted in the advertisement sound impressive, but the advertisement does not mention that they had to do post hoc analysis of a subset of the data in a relatively small number of patients in order to find this number.>>

I'm not sure where you're getting the information on this particular issue. At the time the two Phase 3 trials began, it was agreed that for each patient, the primary endpoint was going to be time to progression, the secondary was going to be time to pain, and survival was going to be followed for three years. Because 9902A was stopped prior to full enrollment, and not every participating patient received the full course of Provenge, the basis of the filing was the 9901 trial, with 9902A providing supportive evidence. All of the survival data submitted to the FDA was for the intent to treat group. No subset data there.

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