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Re: rancherho post# 5053

Thursday, 11/15/2007 10:06:31 PM

Thursday, November 15, 2007 10:06:31 PM

Post# of 12660
If this is true for certain, it obviously lowers the odds of Provenge being approved on the interim survival data. I was thinking prior to today that Provenge in 9902B had about a 2/3 chance of an interim p value being 0.05 or better, and about a 1/3 chance of being 0.01 or better. I'm assuming that 0.01 is the interim alpha and 180 deaths is the cutoff point. If this is all they're going to get from the DSMB, then it's asinine IMO to only allocate 0.01 for the interim alpha. They should allocate 0.02 for the interim and 0.03 for the final, if all they're going to get from the DSMB is whether or not the interim has been met. By 2011, there could be another therapeutic agent on the market. What if they find out in 2010 that the interim was 0.015 and the final was something great like <0.0001? That's two years of lost revenue in a marketplace with only Taxotere as the relevant competition.............dumb.


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