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Re: Whosonfirst post# 153389

Thursday, 03/18/2021 1:42:33 AM

Thursday, March 18, 2021 1:42:33 AM

Post# of 232880
Big arm numbers are for risk mitigation. With small numbers any bad luck is mitigated. I don't need to be a doctor to understand such basic for trials.

If I am in a position where FDA is not in love with me, I have to be with each critical parameter on the safe side. We just learned again: p-value is a ko- criteria. Like it or not, higher numbers creates home runs.

Concentrate money and brainpower. Trials with 50, 200, 400 are just not good enough to secure p-value. We are blaming bad luck, we should blame non existing risk management in place securing our homeruns for a great molecule.

P-value is for science, beaucrats and commercial contracts. If we deal with deaths, I doubt it should be a ko criteria.
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