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Insmed Incorporated Message Board

  • doctordoom54 doctordoom54 Jul 1, 2013 2:06 PM Flag

    The Real Take-Away (4 points)

    Lost big money today with INSM. I am all for the longs making money here, but there is NOTHING, nothing good about theses results, except for no short-term safety issues.

    1) Currently our marvelous drug is "non-inferior" (or just a little inferior) to an established, more affordable alternative. It will never become the standard of care for CF pseudomonal infections. This was my hope, but superiority was needed for this to happen. In the US (insurance-based) or any socialized system, the default will be the proven, equality-effective, cheaper alternative.

    2) For me the CF indication is where the money is. I feel this puts sig question on the delivery mechanism. Penetration of the biofilm in pseudomonal pneumonias via this technology was the main thing I saw going for this drug. The fact that this was not superior to the Tobi dinosaur shows this may be a gimmick only.

    3) There is no guarantee this formulation will do anything at all for NTM infections-- which is a completely different beast. I was convinced of the science behind amikacin for pseudomonads in the lungs. I think it is unlikely to be effective against MAC or other NTM. There is no proven value (ie, correlation between in vitro susceptibility and clinical or in vivo response) for in vitro susceptibility testing for antimycobacterial agents other than the macrolides for MAC. I will not bet a single cent on this.

    4) I am not willing to wait for Iplex given that is won't see the light of day if we can't get through the above. I'm out, forever. GTH Insmed! I will never put another dime here... except for selling some long-term calls.

    Good luck to the longs here and the shorts frankly. I hope everyone makes money, but consider the science here. This is the realm of traders... not scientists or long-term value investors.

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    • Best post this week for those who cant read results.doctordoom54 'The Real Take-Away (4 points)

      • 1 Reply to eastofhgwy1
      • another good post from the same thread by

        rehdvm2004 • Jul 1, 2013 2:51 PM Flag

        3 users liked this posts users disliked this posts 0
        Reply
        .

        With the goal being how to "clinically prescribe the use this Arikace formulation in the most therapeutic regimen" (i.e., get a label copy indication) the following points are important for INSM management to consider:

        1. There has not been a superior inhalational antibiotic to TOBI among the two or three that are now complete. I think both Cayston and Azithromycin have been compared. Now Arikace.
        2. Novartis has developed new inhalational devices for their inhalational antibiotics and is attempting to replace TOBI with TIP.
        3. The most troubling finding was why the liposome did not have a better comparative effect on FEV1 (both inhalational treatments tracked about the same, but Arikace did not have the 14% improvement seen in the Phase IIb trial). This is perhaps the most troubling finding.
        4. Both NIH and CFF are now talking up the rotation of inhalational antibiotics to preclude resistant strains. Gilead actually has a clinical trial investigating rotations with TOBI. That discussion is going to be more important in the next 5 years and be the subject of lots of Phase IV studies.
        5.Point 2 (above) does not mention the uptake by the fixed macrophages where bacteria (particularly NTM) can hide in an infected lung. This uptake by fixed macrophages suggests that Arikace would have a better chance at being efficacious against NTM. The recent post by ??? who looked up the fact that NTM replicates about once per day (very slow growing) is critical to the belief by NIH scientists and INSM that Arikace might be a breakthrough drug for this purpose.
        6. WL has the first big challenge of his tenure at the helm of INSM . . . what "remedy" can he and the other scientists at INSM come up with to get this project on-track for approval by EMEA (I think the data is not transferrable to FDA) and should they refocus and go all

    • 1) It will never become the standard of care for CF pseudomonal infections.
      2) For me the NTM indication is where the money is.
      3) There is no guarantee this formulation will do anything at all for NTM infections
      4) I am not willing to wait for Iplex given that is won't see the light of day I hope everyone makes money, but consider the science here. This is the realm of traders... not scientists or long-term value investors.

    • With the goal being how to "clinically prescribe the use this Arikace formulation in the most therapeutic regimen" (i.e., get a label copy indication) the following points are important for INSM management to consider:

      1. There has not been a superior inhalational antibiotic to TOBI among the two or three that are now complete. I think both Cayston and Azithromycin have been compared. Now Arikace.
      2. Novartis has developed new inhalational devices for their inhalational antibiotics and is attempting to replace TOBI with TIP.
      3. The most troubling finding was why the liposome did not have a better comparative effect on FEV1 (both inhalational treatments tracked about the same, but Arikace did not have the 14% improvement seen in the Phase IIb trial). This is perhaps the most troubling finding.
      4. Both NIH and CFF are now talking up the rotation of inhalational antibiotics to preclude resistant strains. Gilead actually has a clinical trial investigating rotations with TOBI. That discussion is going to be more important in the next 5 years and be the subject of lots of Phase IV studies.
      5.Point 2 (above) does not mention the uptake by the fixed macrophages where bacteria (particularly NTM) can hide in an infected lung. This uptake by fixed macrophages suggests that Arikace would have a better chance at being efficacious against NTM. The recent post by ??? who looked up the fact that NTM replicates about once per day (very slow growing) is critical to the belief by NIH scientists and INSM that Arikace might be a breakthrough drug for this purpose.
      6. WL has the first big challenge of his tenure at the helm of INSM . . . what "remedy" can he and the other scientists at INSM come up with to get this project on-track for approval by EMEA (I think the data is not transferrable to FDA) and should they refocus and go all out for NTM.

      Lots of major issues here.

      GLTAL. We are going to need it further.

      Sentiment: Hold

    • Thanks for your post but jmho the FDA gave NTM the QDIP and fastrack designation this morning..of course there is no guarantee,but I like its chances vs say CF

    • Then I assume you have sold and are now leaving the board. Goodbye and good luck.

      Sentiment: Buy

 
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