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Re: kris_kade post# 64621

Thursday, 02/07/2013 8:30:03 AM

Thursday, February 07, 2013 8:30:03 AM

Post# of 97239
I was originally thinking a CRL, but have changed to a 60-40 chance of a restricted label. Some informed folks seem fairly sure—based mainly on the briefing docs—of a full approval, but that means the FDA goes against the ADCOM rec which usually doesn't happen.

Regardless, considerable damage has been done to the PPS, perhaps for the foreseeable future, and I'm not sure that any flavor of approval will significantly move the dial while a CRL might move it from $3 back to $2.

I'm underwater here, just looking for a bit of a run-up next week to sell into. Will definitely not hold through!

All that is needed to make a happy life is within yourself, in your way of thinking. -Marcus Aurelius

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