I think in regards for future trials for any indication we need to tailor our PE’s on exactly what we can guarantee From my understanding MSB has had a broad brush ie we take on all comers and the smarter pharma applications have always played the man and not the ball so to speak and consequently their trials have passed with getting the PE’s
Maybe that is why so many drugs end up having issues later
We have to get smarter with these things and not try to win a nobel prize
Ann: FDAs OTAT Agrees to Primary Endpoint for Back Pain, page-175
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