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Insmed Incorporated Message Board

  • mike75x5 mike75x5 Aug 6, 2013 9:00 AM Flag

    Details, impressions from the call?

    I can't listen, will be on the road. What are we hearing?

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    • Europe:targets 4 countries where 50% of targeted population of patients are: Ireland, GB, France and Germany. Personnel needed: 50-100.
      Arikace producers almost in place.
      With NTM, hand in hand with the FDA to get an adequate road to get it admitted as a medicine.
      CF (Europe) and NTM (USA) will be launced about the same time.
      And: money till 2015
      GT

      Sentiment: Strong Buy

      • 3 Replies to gt_pharma
      • Europe:targets 4 countries where 50% of targeted population of patients are: Ireland, GB, France and Germany. Personnel needed: 50-100.
        Arikace producers almost in place.
        With NTM, hand in hand with the FDA to get an adequate road to get it admitted as a medicine.
        CF (Europe) and NTM (USA) will be launced about the same time.
        And: money till 2015

        Sentiment: Strong Buy

      • To expand a little on your comments, there will be a North American Cystic Fibrosis meeting in October where WL intends to submit complete results from the recent P-3 CF study. Hopefully, this presentation will include some preliminary P-3 open label extension study results. If these latter results are generally positive, the prospects for EU drug approval in the first half of 2014 would be greatly improved.

        I think it is important to stress that WL does not anticipate the need for a P-3 US trial for NTM. As you mentioned, WL stated that he hopes/anticipates Arikace commercialization for CF in Europe and NTM is the US to occur about the same time.

        WL also stated that FDA and other medical experts have "tremendous enthusiasm" about the prospects for Akikace in the treatment of NTM. Very bullish statement that, I would think, would infuriate the FDA if it were not true.

        Basically, a very positive call today. Plenty of cash, lots of enthusiasm for more positive clinical findings, and a quality management team that is ready and able to execute.

      • Thanks for the info. Sounds like a plan is being executed and the market seems to like it today.

 
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