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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?


To: Jibacoa who wrote (1807)10/5/2007 11:22:13 AM
From: Jibacoa  Read Replies (1) | Respond to of 3722
 
POZN Started to move some today after news.

The stock is up 10% on volume of 725Ks.

bigcharts.marketwatch.com

POZEN Plans to Submit Response to Approvable Letter For Trexima(TM) Within the Next Ten Days
Friday October 5, 8:30 am ET

CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News) announced today that it plans to submit a response to the Approvable letter for Trexima received on August 1, 2007, within the next ten days.

This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable letter.

POZEN believes the submission will constitute a full response. The submission will include clarifying non-clinical information to further address the agency's concern regarding the genotoxic potential of Trexima and, as required by FDA, a routine clinical safety update.

The FDA may take up to six months to review this submission, although POZEN will request an expedited review.

Snip

The stock was able to close part of its Aug 2 DG on Sep 7, but the UG on that last day has been fully closed.

bigcharts.marketwatch.com

Bernard