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EYEBUYSTOX

08/27/12 8:27 PM

#147780 RE: DewDiligence #147768

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.
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pcrutch

09/07/12 10:55 AM

#148311 RE: DewDiligence #147768

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



http://thoracicsymposium.org/Thoracic-Daily/tdaily_detail_97_5.html