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Re: bwolfy2002 post# 80502

Tuesday, 05/26/2020 5:31:45 PM

Tuesday, May 26, 2020 5:31:45 PM

Post# of 232289
not sure what the protocol is for interim results. They can do the analysis when they have results for 50. Do they have to commit to public release of interim results before the data are unblinded? If so, unblinding early would be a big risk because if effect is real but not large enough to show a significant result with a small sample size, it kills the chances for future enrollment.

I thought I heard NP say that FDA recommended that they wait for full enrollment before announcing any interim results. It also sounded like he said that DrP and other researchers are eager for early unblinding because they are confident in the results.
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