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Gametheory101

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Gametheory101

Re: corpstrat post# 50163

Tuesday, 07/24/2007 7:08:18 PM

Tuesday, July 24, 2007 7:08:18 PM

Post# of 252588
I believe we all thought that with a large trial and strong stat sig, albeit of a result with precious little clinical value, this would be a shoo-in.

The clear message from the Pazdur/Hussain/Sher/Flemming contingent in power at the FDA is they want survival data for cancer drugs.

The irony is Provenge had solid survival data, yet they wanted a larger trial that was pre-specified to be "sure", or, they wanted 9902B. Why would they change their stripes for GPCB?



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