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lovethatgreen

03/08/13 2:38 PM

#2835 RE: ARBITRARY & CAPRICIOUS #2833

I do not rule out another CRL



no man..if there was going to be another CRL on top of the last CRL they just spent 3 years working on, then the FDA instead of issuing a CRL and certainly and definitely no PDUFA date just 2 weeks after the NDA filing, would have then and there most likely just denied the application.

I suggest you get familiar with the jan 7 presentation.
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lovethatgreen

03/08/13 2:48 PM

#2838 RE: ARBITRARY & CAPRICIOUS #2833

I would love for you specifically to list off the causes for a CRL after them just handling the last one perfectly IMO

What institutions are under water? show me