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Ampio Pharmaceuticals, Inc. Message Board

  • arbtrdr arbtrdr Oct 30, 2013 3:37 PM Flag

    FDA Meeting

    The meeting yesterday had no significant news. Thus AMPE will begin enrolling patients for a final trial. That trail wil take about 20 weeks to get results. At that point AMPE needs to put in an application and the FDA has about 60 days to respond. That then starts the clock for the review process of either an expedited review or the full review. Figure May 2014 for the final study and another 6 months to a year for final aproval.

    Optina interestingly has almost exactly the same schedule for the approval process. IR also reported negotiations continue with Zertane for a pertner.

    What does this mean - we have a while to wait and as things get closer to approval then the companies who would be pushed out by the approval of AMPE's Ampion and Optina will probably come back again to try to either buy AMPE or buy the products. AMPE has products that others would like to either own or have go away. Still lots of moving parts.

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