POZEN Inc. (POZN) announced after the bell Wednesday that it has received an Advice/Information Request letter from the FDA. The FDA has made a preliminary review of the study results and POZEN's summary analyses of a Phase 1 study to assess the bioequivalence of PA32540 to enteric-coated aspirin 325 mg using acetylsalicylic acid as the analyte. The FDA does not agree that bioequivalence of PA32540 to EC aspirin 325 mg was demonstrated.
POZEN traded in a narrow range throughout Wednesday's session and closed down by 0.03 at $7.45. The stock is now down 1.29 on 12K shares after the bell.
by RTT Staff Writer
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