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Re: DewDiligence post# 984

Tuesday, 09/12/2006 12:46:33 AM

Tuesday, September 12, 2006 12:46:33 AM

Post# of 12660
the reason I expect Provenge to get an approvable letter on the first review cycle is that 9902a was not genuinely supportive of 9901, and 9901 was obviously insufficient for approval on its own.

so, in effect, you are saying that the pooled data's log rank p-value of .011 with an HR of 1.5 (which suggests that patients who received placebo have a 50% greater chance of dying than those who received Provenge) is not significant/insufficient and requires more data?

sounds like the same type of comment ill-informed doctors have made suggesting that Provenge trial sample size is too small for the results to be considered significant, even though the p-value (log rank) suggests the complete opposite.
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