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DewDiligence

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DewDiligence

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Re: biomaven0 post# 194090

Wednesday, 08/05/2015 1:23:34 PM

Wednesday, August 05, 2015 1:23:34 PM

Post# of 257275

MCUR—…that would play havoc with the significance analysis. The case you describe is different from an upsizing following a power analysis.

I’m reporting what was actually discussed on the CC. Although MCUR didn’t confirm that they would seek to upsize the enrollment in case #2, they didn’t rule it out.

The alpha penalty for upsizing is something that could presumably be negotiated with the FDA.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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