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

To: Jibacoa who wrote (1941)	10/15/2007 9:44:10 AM
From: Jibacoa	Read Replies (1) \| Respond to of 3722

POZN Is trading above $10 as it will try again to close some of its Aug 2 DG, with the help of some news.<g> bigcharts.marketwatch.com Pozen Submits Response on Migraine Drug Monday October 15, 9:11 am ET Pozen Submits Data on Migraine Drug Trexima to FDA to Respond to Agency's Approvable Letter CHAPEL HILL, N.C. (AP) -- Drug developer Pozen Inc. said Monday it submitted data from three non-clinical studies to the Food and Drug Adminstration on its migraine drug candidate Trexima, in response to the agency's Aug. 1 approvable letter. Pozen and partner GlaxoSmithKline PLC recently met with the FDA to discuss the companies' proposed plan for satisfying the agency's information request. Pozen also submitted a required routine safety update and revised product labeling. The FDA may take up to six months to review this submission, although the company has requested a 60-day review. In addition, the company said this quarter it will launch a clinical evaluation of the genotoxic potential of Trexima in a short-term study in human volunteers. Genotoxicity is any toxic change to DNA's structure or function. Results will be available for submission to and review by the FDA, if required, during the first quarter of 2008. "Although we believe that our submission addresses FDA's concern regarding the genotoxic potential of Trexima, we feel it is prudent to conduct this clinical trial so that we can provide this information without delay, if required," said Dr. Marshall Reese, executive vice president, product development. In order to close its Aug 2 DG the stock has to get back above the $14 level. bigcharts.marketwatch.com Bernard