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Insmed Incorporated Message Board

  • michael_coen Jun 20, 2013 8:58 AM Flag

    QIDP status imminent

    We know (for a fact) that QIDP status was requested (regarding NTM) to the FDA before April 30 (when it was first publicly mentioned by WL at the Needham Healthcare conference).

    Since then WL has hinted that QIDP status has been requested for CF as well (depending how you interpret his words). As far I'm concerned the request has also been made for the CF indication.

    I'm searching the FDA site to see if there is a "status" or "applications" page (like there is for Orphan Designation) but I cannot find one.

    What I have found, is that the FDA is obliged to confirm or deny the designation within 60 days of the request submission - and NOT just to "respond", so the idea that the FDA can take 60 days to say "we're looking into it" is mute.

    By next Friday 28th (very latest Monday 1st July) we should know (otherwise Insmed is in breach of SEC rules timely disclosure of material information)

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