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Re: walldiver post# 3359

Thursday, 05/10/2007 2:49:28 AM

Thursday, May 10, 2007 2:49:28 AM

Post# of 12660
Agreed, the likelihood is low, because of Fleming's other criticisms such as not having an alpha allocated for OS.

However, I do have a burning question on this statement of yours, if "The pain situation is completely out", meaning all newly enrolled patients after protocol amendment in late 2005 have pain symptom to begin with, and all patients enrolled pre-2006 would have developed pain by 2008, then what is the harm of approving a drug for asymptomatic patients, given the placebo patients will not be eligible for reimbursement so there won't be any significant cross-over, because it is off-label?

It really sounds like the 9902b trial integrity issue is sufficient to sway the decision?

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