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Re: DewDiligence post# 110356

Tuesday, 12/07/2010 10:26:54 PM

Tuesday, December 07, 2010 10:26:54 PM

Post# of 257253
I am not aware any agent got accelerated approval with less than 20% ORR. Technically speaking, FDA had said lower confidence interval of 10% could be approved. Consider the size of these types of trial, that usually is 20% or higher actual number.

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