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Re: DewDiligence post# 970

Monday, 09/11/2006 7:33:00 PM

Monday, September 11, 2006 7:33:00 PM

Post# of 12660
"companies would not design in explicit p-value allocations for survival."

Could you provide some precedents where what you allege is true -- trials where FDA has allocated p value has been between a surrogate for an endpoint and that endpoint itself (for example a trial in which p value is allocated between a progression endpoint and survival).

Ocyan's and Clark's point is that there is no need for such allocation and Ocyan post has a link to the ODAC discussion about that topic.

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