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biomaven0

03/16/12 2:05 PM

#17225 RE: moneyman1010 #17218

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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DewDiligence

03/16/12 2:36 PM

#17228 RE: moneyman1010 #17218

RACHEL MCMINN thinks no approval. hopefully wrong like the rest of her calls.

She may be wrong on this matter, but McMinn has one of the best track records overall of any biotech sell-side analyst.

p.s. Taltorvic is one of the worst brand names I’ve ever heard (#msg-73348538).