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MannKind Corp. Message Board

  • howcomethisdoesnotwork howcomethisdoesnotwork May 13, 2013 7:58 AM Flag

    Timeline for NDA, Preliminary Approval, and Approval

    So, let me get this straight, in August the clinical data will be available, and shortly after that there should be a partner available if it looks very promising. Then the NDA will be submitted by October to the FDA, in which case the FDA will have 60 days (basically before year end) to reject it, or say that they will have a full review, in which case it could be months to 1.5 years for final NDA approval, and hence first sales won't come in most likely until later in 2014, or 2015.

    Hence maybe by August shares trade above $10 on data, and $15 on partnership and FDA submission, and maybe break the $20 upon approval? This could be tricky, but any share price that break through $20 i would sell in the short term, even if the shares can break $50 by 2016.

    What is the likely approval time range from October 2013 to Market Authorization by the US FDA ?

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