> GPCB – Which was the SPA'd endpoint back in 2003? Based on earlier news release, primary endpoint was ttp, secondary are pain and survival. the current news release seemed to have mixed all three together and called it PFS?<
The SPA was amended in 2005, changing the primary endpoint from TTP to a composite PFS.
>A PFS difference of less than 2 weeks, which could be well within windows of assessment errors, with bulk of events based on unverifiable pain progression, with slightly worse OS what's the ground for approval?<
???
Are you referring to the median PFS? I thought you were more sophisticated than that with respect to biostatistics.
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