That is indeed strictly correct, but also beside the point, because we do need to hit some platonic ideal of absolute truth in our trials, but only the FDA’s operational definition of success. And the FDA’s operational definition of success is passed if there’s only a 1 in 20 chance, or less, that the result was a fluke. ie p<0.05. We don’t have to prove it to God, just the FDA.
Ann: PAR Reports Successful Primary Endpoint in Phase 2 Trial, page-75
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