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Post# of 252553
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Alias Born 01/02/2003

Re: corpstrat post# 50163

Tuesday, 07/24/2007 5:47:40 PM

Tuesday, July 24, 2007 5:47:40 PM

Post# of 252553
It's stunning, I agree. A lot of focus is on the median PFS, which is statistically significant but not clinically significant. However, once you get toward the PFS at the 65 and 75 percentiles, satra was quite significant clinically. On the other hand, the FDA is clearly not happy that GPCB has been claiming the whole time that GPCB met its obligations concerning the signed SPA. Including the pain metric in the PFS endpoint, plus using the PFS endpoint in the first place, was a no-no.

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