Research analyst, medium-term horizon, biotech, small-cap

Pozen Resubmits PA NDA, PDUFA In Two Months?

On July 1, 2014, Pozen Inc (NASDAQ:POZN) announced it had resubmitted the New Drug Application (NDA) for PA81/40 and PA325/40 to the U.S. FDA. Pozen noted that the FDA is expected to notify the company within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. More specifically, we will find out in two weeks if the FDA will take two months or six months to review the application.

We remind investors that on April 25, 2014, Pozen announced receipt of a complete response letter (NYSE:CRL) for PA8140/PA32540. In the CRL, the FDA noted that, "During an inspection of the...

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