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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Aug 14, 2013 8:20 AM Flag

    Will Lewis presentation at 5 PM

    Let's see if anything new comes out. Interested in the last NTM patients having been enrolled.

    I imagine the Paul's presentation yesterday was pretty much a restatement of the CC.

    GLTAL

    Sentiment: Strong Buy

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    • While the negotiations about CF/Pa go on, the emphasis for Arikace has clearly shifted to NTM. WL is an excellent speaker who keeps hammering the strongest points about Arikace:

      1. Once per day. Guarantees that patients will receive treatment.
      2. Neutral distribution to the lungs for thorough distribution.
      3. Uptake by fixed macrophages where the NTM offending bacteria are concentrated.
      4. Improved quality of life by virtue of decreased bacteria (most likely, but not shown YET), improved FEV1 and "feeling better."
      5. These therapeutic improvements among the worst NTM patients that have just come off 6 months of other therapy.
      6. And 25 of 81 plus have elected to continue under EAP.

      For the first time also, WL stated that they are discussing results biweekly with FDA.

      If I was under Dr. Kenneth Oliviers staff and the "qualitative clinical data" was that encouraging, I would ask to unblind a statistically significant subset of data (the first 50 patients) and look at the primary therapeutic effect . . . decrease in NTM. Like most infections, the earlier the infection is treated, the less lung damage. Lungs scar with chronic infections and scars never function as normal lung again. So if the first time a patient is cultured positive for NTM and treated with Arikace, the probability is they might get treated again in 6 months, but the chronic lung scaring would be averted.

      GLTAL

      Sentiment: Strong Buy

      • 2 Replies to rehdvm2004
      • rehdvm2004 • Aug 14, 2013 6:47 PM Flag
        7users liked this postsusers disliked this posts0Reply
        While the negotiations about CF/Pa go on, the emphasis for Arikace has clearly shifted to NTM. WL is an excellent speaker who keeps hammering the strongest points about Arikace:

        1. Once per day. Guarantees that patients will receive treatment.
        2. Neutral distribution to the lungs for thorough distribution.
        3. Uptake by fixed macrophages where the NTM offending bacteria are concentrated.
        4. Improved quality of life by virtue of decreased bacteria (most likely, but not shown YET), improved FEV1 and "feeling better."
        5. These therapeutic improvements among the worst NTM patients that have just come off 6 months of other therapy.
        6. And 25 of 81 plus have elected to continue under EAP.

        For the first time also, WL stated that they are discussing results biweekly with FDA.

        If I was under Dr. Kenneth Oliviers staff and the "qualitative clinical data" was that encouraging, I would ask to unblind a statistically significant subset of data (the first 50 patients) and look at the primary therapeutic effect . . . decrease in NTM. Like most infections, the earlier the infection is treated, the less lung damage. Lungs scar with chronic infections and scars never function as normal lung again. So if the first time a patient is cultured positive for NTM and treated with Arikace, the probability is they might get treated again in 6 months, but the chronic lung scaring would be averted.

        GLTAL

      • Great post rehdvm, You're the man! The one thing that fuddy keeps forgetting is that Insmed filed the shelf before Russell inclusion, so of course WS knew Insmed was going to finance. But they need to, because the need for 200 L of production couldn't be delayed a moment longer!
        pianoman

        Sentiment: Strong Buy

    • Access through insmed website, Investor Relations - Events & Presentations

      Sentiment: Buy

    • Let's hope!

 
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