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Re: DewDiligence post# 49956

Sunday, 07/22/2007 4:37:33 PM

Sunday, July 22, 2007 4:37:33 PM

Post# of 257470
Satraplatin - If the survival data are the focal point of the ODAC then I would guess the submitters are going to have problem - because the survival data appear to be trending to an HR that would not be stat sig.

Note that I haven't done any detailed analyses and know very little about the trial history of this drug - so I am not competent to speak to the general review. I am instead only making a micro observation - extrapolating from the fact that the current p value is about 0.3 and more than 1/2 of the deaths have occurred.

Clark

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