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Insmed Incorporated Message Board

  • michael_coen@ymail.com michael_coen Sep 9, 2013 7:11 AM Flag

    CF/Pa phase 3 "Final data will be presented at NACFC"

    NACFconference dot org
    click on the Wiley Online Library link (for the abstracts summary)
    and in the "Poster Session Abstracts (pages 207–453)" you will find poster #235

    LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE) COMPARED WITH TOBI® IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTION DUE TO PSEUDOMONAS AERUGINOSA
    Bilton, D. et al

    in which is stated (section "results"): "Final data will be presented at NACFC"

    October 17-19 at Salt Lake City

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Who peer review?Mormons?.Go look fo dat poster.It have bright colors and mumbo jumbo cuz they dont have to tell you everything and THEY WONT! da europeans and befo dat the FDA \\\\\\ you see

    • michael_coen@ymail.com michael_coen Sep 9, 2013 7:31 AM Flag

      Lewis blew all the good news at once at the July 1st conf call (QIDP, fast-track, Russel inclusion, Phase 3 data, even mixing/confusing NTM and CF/Pa news in the same call) when (guess what) short selling went through the roof that day (to enable his friends to buy into the latest "public" secondary on the cheap).

      Then, at the Conaccord Presentation (August 13) Will Lewis practically admitted what the July 1st phase 3 "top line data" was massaged to look comparable to tobi ("inferior" as Terry likes to say) when in fact no one (at that July 1st meeting) dug into the differences between the Phase 2 and Phase 3 trials, ie. the fact that sicker patients were excluded from phase 2. THIS (detail) is what's coming October 17th at the NACF.

      WL at August 13th Conaccord:

      "We are going to be sharing more details about our data at NACF in October, and I think there we will try and tease out where we may be able to show better performance than tobi, because what we have said to date is that we are comparable to tobi (we continue to stand by that)".

      "When you dig into orphan diseases, one of the important things to realize is the way you win (against orphan diseases, both clinically and commercially) is to go after the areas where you know the drug is going to have the best impact. So we will sub-section the CF population to identify those patients where we know we will be able to beat tobi".

      "And I think when we can share those data and try to talk about that story at NACF around peers where peer review can take place, that will be the most compelling. And the strategy that flows from that will simply be to go after Europe in a way that acknowledges that the days of launching in 5 countries and spreading out from there are over".

      • 3 Replies to michael_coen
      • Data will be massaged again.The only "peer review" will be in 2014-2015 EU.What did the FDA see that caused Insmed not to trial in the US?.Obviously the results are not compelling. Good Luck

      • So for clarification, "the sicker patients were excluded from Phase 2." what are we to assume the results would have been had they been included? Results much better because the drug was able to penetrate the lungs better due to the liposomes, or much worse because the sicker patients had been included, and the results would not had been significant due to the level of sickness of the patient?

      • michael_coen@ymail.com michael_coen Sep 9, 2013 7:59 AM Flag

        Sorry... Not to be misleading, and to be more explicit, what's coming (at the NACF conference) is a supposed complete peer-reviewed presentation of the efficacy of Arikace vs Tobi: ie. how effective is Arikace (once/daily) compared with TIS (twice daily).

        I meant that for me (myself) I'll then able able to understand the difference between the "amazing" phase 2 data and the "inferior" phase 3 top-line data.

        Shall we expect stock price appreciation at that time? Who knows? The data may remain "massaged" until after the presentation of the extension study where we see the long-term sustain affects. This may be one conference well worth the two-thousand bucks or whatever it costs for a one-day ticket. hmmm...

    • D. Bilton is hinting....

      Conclusion:
      (...) Data from this Phase 3 study will inform the comparative
      efficacy and safety of LAI administered once daily versus TOBI adminis-
      tered twice daily. We believe these data will be important in furthering our
      understanding of intervention with a new antibiotic in the treatment of
      chronic Pa infection in CF patients, an area of significant need.

      Sentiment: Strong Buy

 
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