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Re: moneyman1010 post# 17218

Friday, 03/16/2012 2:05:39 PM

Friday, March 16, 2012 2:05:39 PM

Post# of 80490

FDA looks likely to reject ridaforolimus



I believe she (Rachel) is wrong on this. As I posted on SI, the short median PFS advantage is mostly an artifact. As the Merck briefing docs calculate, a 6 week PFS advantage based on the HR is a more realistic number (which is less than what it is at both 40% and 60% PFS).

They had an SPA and hit it easily. A survival trial is impractical (by Merck's calculations would require 1100 patients over 6 years).

Peter



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