PPHM—I concur that the FDA is very likely going to want another trial, just as they did with Provenge. However, if the fully mature data actually improves from here and there are no obvious imbalances in the arms, they might yet have a shot.
Respectfully, I think PPHM has no shot whatsoever at accelerated approval based on the second-line NSCLC trial, no matter how the data mature. On today’s CC, there was no mention whatsoever of AA, and there were plenty of opportunities to mention it in the context of what happens next, such as the end-of-phase-2 meeting and the planning of a phase-3 trial.
PPHM’s floating the notion of AA on its previous webcast was entirely bogus, IMHO, and was intended mainly to mislead unsophisticated investors.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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