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Biotech / Medical : Welcome to the POTP board, the DPP-IV company -- Ignore unavailable to you. Want to Upgrade?

To: former_pgs who wrote (14)	8/9/2006 12:54:20 AM
From: rareearth42	Respond to of 90

pgs, I have to concur with your reasoning and I should have thought about this in greater depth. Usually PFS is used as a surrogate in oncology trials if the real endpoint of interest, survival, would take too long for the practical design of a trial. In the case of NSCLC, as you know, this generally isn't an issue. Given the clinical circumstances of NSCLC, should a survival benefit be established clearly even as a secondary endpoint, I would expect favorable action by the agency. I agree that PFS in the absence of a survival benefit for NSCLC is not compelling and shouldn't be the basis for approval. RE42