Biotech Values

[DewDiligence]

PPHM—That table puts to rest the silly notion that the primary endpoint in the second-line NSCLC trial—ORR—was statsig; in fact, the p-value was 0.21. (As several people on this board noted, if the primary endpoint had been statsig, PPHM would surely have said so months ago.)

We can also dismiss an FDA accelerated approval in second-line NSCLC based on this trial, although PPHM executives continue to suggest that such an outcome is possible—without actually saying so—by using vague and deceptive language such as the quoted passage in #msg-79172611.

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Will Bavi work in second-line NSCLC in phase-3? Possibly, but I doubt it given the failure in first-line NSCLC and the manifold failures in myriad other indications.

iwfal’s post in #msg-68164207 is pertinent here—i.e. if you test a placebo drug in enough trials and settings, the probability of observing a false-positive outcome somewhere is fairly high.