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Re: DewDiligence post# 49931

Friday, 07/20/2007 1:10:39 PM

Friday, July 20, 2007 1:10:39 PM

Post# of 257439
"However, GPC subsequently increased the event-count trigger for the PFS endpoint"

Seems that they increased OS counter as well - was it re-SPA'd

FDA document states " Initial estimated sample size was 912 to have 602 deaths within 36 months... It was later decided to increase the power to 90%, requiring 700 deaths"- by whom?

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