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Re: Evaluate post# 81637

Tuesday, 11/01/2016 9:50:52 AM

Tuesday, November 01, 2016 9:50:52 AM

Post# of 702591
Evaluate, I agree that 6 months is way too long. But 2-3 months is very reasonable.

They need to get every bit of data properly recorded. Double check, clean up any errors they find. Once done, only then will the unblind it. And there is a ton of data.

As a note, DNDN made a mistake in the process in the 2007 datasets. It turned out not to matter, but could well have been crucial. They reported a P value of something like P=.08 for PFS, but then later said it was really P=.056 had they not screwed up a scan or two. Had the trials played out differently, that exact error could have cost them an approval.
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