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Re: DewDiligence post# 5631

Friday, 04/11/2008 3:23:51 PM

Friday, April 11, 2008 3:23:51 PM

Post# of 12660
"obtaining 56 more events pales in comparison to the nightmare scenario where: a) Provenge really does have good efficacy; b) the new 9902b trial fails; and c) the old 9902b trial would have succeeded."

How do you think FDA will react if the new 9902b trial fails to show a statistically significant benefit, but upon 56 more deaths that it swings the p-value to below the magical 0.05 level. Will you be certain that FDA will reject study 9902b altogether?


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