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Pozen, Inc. Message Board

  • play_tow play_tow Aug 7, 2014 11:18 AM Flag

    Great CC for POZN...

    PA140---EU judges no additional clinical trials needed. Preparing submission, and partnering agreements.

    Trexmet-ROW moving forward for partnering agreements.

    Requested FDA for prioritized review of their NDA, once FDA has judged vendor to have addressed their concern.

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    • Q&A:

      Company quite confident for PA140 EU approval. No application yet filled, but now plan for submission. No partner yet in hand, but not viewed critical at this time. CEO mentions big EU study showing massive benefit of aspirin for heart disease and cancer. Major inhibitor to patients is GI impact of Aspirin. PA solves the latter and CEO wants their med to be affordable.

      Concerning FDA, company feels they will hear from FDA about the vendor issue in Q3.

      Seeking License Agreement for ROW Trexmet

      JasonNapotondo inquired about prioritization on PA review. CEO indicates no outstanding issues aside form manufacturing facility. Once they learn the facility is up to standard, POZN will seek prioritized review. No reason why FDA can't decide on full PA application and approval. Worst case is Dec 30, but company is guardedly optimistic of early review. FDA would give a heads up, and POZN would update the markets.

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