Replies to post #148311 on Biotech Values

[north40000]

You obviously have not read enough of data that is already published. Stick around for this afternoon!

What is the rationale for your opinion "PPHM's trial must be severely imbalanced."

[Robert C Jonson]

"PPHM's trial must be severely imbalanced. No way should the control arm be that low. "

Funny, you didn't complain when the control arm for 1st-line NSCLC was abnormally high...

[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.