Biotech Values

[EYEBUYSTOX]

PPHM - Humor me...

If a drug's MOA was only starting to reveal its efficacy when PFS and ORR were first reviewed, and it ultimately offered a significant benefit in overall survival you surely are smart enough to know that the FDA would recognize the clinical benefit and consider accelerated approval regardless of what endpoints the trial had. Especially if there were CRs in the trial. All "ifs" but consideration would surely be made for AA in such an "outlandishly optimistic" scenario.