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Insmed Incorporated Message Board

  • kinkey_boots kinkey_boots Nov 24, 2013 10:50 AM Flag

    Scaled results IF that happens ,rehdvm2004

    a banner day for headlines at INSM and elsewhere when that happens.

    IF that happens.Your spin MAY happen and MAY NOT.It's blinded and everyone involved knows it.

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    • The point that I find encouraging is that KN Olivier enrolled only 90 patients. Not the 100 that was agreed to with the FDA. So that suggests two outcomes. That Arikace was not knocking down NTM significantly and they stopped/terminated the study; or the outcome was so convincing that they achieved statistical significance with 90 patients and ten more would not have affected the conclusion about the clinical trial. I tend to lean towards the latter because of looking at the results of so many efficacy studies across the years beginning with Baxter Healthcare in the mid 1970s. Remember INSM committed to spending $15-18 for those 100 patients to get an orphan, totally proprietary prescription label into the late 2020s. If Arikace was NOT achieving the anticipated efficacy, they would have quit after 50 patients. They did not. Now they are focused on the EAP clinical trial and cutting off that 6 month pre-enrollment criteria.


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