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POZEN Inc. Message Board

  • yrubinek yrubinek Apr 27, 2014 6:56 AM Flag

    FDA wants PL product to replace current Aspirin avaliable on the market and they will act fast

    The same as they did with ....

    "CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ:POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that following ongoing interactions with the United States Food & Drug Administration (FDA) concerning its New Drug Application (NDA) for PA8140/PA32540 tablets, the Company has decided to conduct a comparative Phase 1 pharmacokinetic study. The goal of the study is to determine the pharmacokinetic profile of the omeprazole component of PA8140 tablets and compare it to that of PA32540 tablets. Both PA dosage forms contain 40 mg of omeprazole in an immediate release form and are manufactured using nearly identical procedures.

    The Company anticipates that this study, which will enroll up to 30 subjects, will cost approximately $750,000. Final data are expected to be available in March 2014. POZEN and the FDA have agreed that the Company will submit study information and data to the FDA as it becomes available during the conduct of the study and that FDA will review such information and data from the study when submitted. The FDA has informed POZEN that the Company’s user fee date of January 24, 2014 (PDUFA Date) is now April 25, 2014. "

    I believe it's less them 100 days to get approve.

    Sentiment: Strong Buy

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    • Perhaps they are rooting for PLX Pharma the edge and to catch up? PLx is a pharmaceutical company developing GI safer formulations of proven non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin and ibuprofen for prescription and over-the-counter markets. PLx has created novel NSAID formulations, using the PLxGuard™ technology, which have the potential to reduce the serious and common gastrointestinal side- effects caused by NSAIDs.
      I believe that this where someone should be looking at in regards to the FDA.

    • Keep Dreaming.

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