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Insmed Incorporated Message Board

  • blank2thisone blank2thisone Oct 15, 2013 8:43 AM Flag

    !! globally uncontested !!,Japan & SAWP

    Separately, Insmed announced that it commenced the Scientific Advice Working Party process with the European Medicines Agency expects to have discussions with the EMA regarding ARIKACE for NTM lung disease during the fourth quarter of 2013. In addition, the Company is in the process of evaluating other international markets, such as Japan, where NTM lung infections are already a significant and growing unmet medical need. Insmed is actively developing a strategy for more broadly commercializing ARIKACE in this globally uncontested orphan disease market.

    Sentiment: Strong Buy

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    • Nice SEC filing!

      Sentiment: Strong Buy

      • 1 Reply to blank2thisone
      • The Phase 2 clinical study is a randomized, placebo
        -controlled study of ARIKACE in adult patients with
        recalcitrant NTM lung disease.
        Eligibility for the study required patients to have
        been on the American Thoracic Society/Infectious D
        isease Society of America (ATS/IDSA)
        guideline therapy for at least six months prior to
        screening with persistently positive mycobacterial
        culture. All patients in the study continued
        with their antibiotic regimen, and received additio
        nally, either ARIKACE or placebo, delivered once da
        ily via an optimized, investigational
        eFlow Nebulizer System (PARI Pharma GmbH).
        The primary efficacy endpoint in the study is the s
        emi-quantitative measurement of the change in mycob
        acterial density on a seven-point scale
        from baseline (day one) to the end of the randomize
        d portion of the trial on day 84. Mycobacterial den
        sity is a measurement currently used in
        clinical practice to assess the progress or decline
        of those patients with recalcitrant NTM. Following
        the randomized portion of the study, all
        eligible patients may choose to receive ARIKACE onc
        e daily for an additional 84 days in an open-label

        Sentiment: Strong Buy

    • Very exciting read this morning. Also exciting is Pre-market shares traded (small amount, but still) for roughly a 3 1/2% pop

14.07+0.03(+0.21%)Oct 24 4:00 PMEDT