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Insmed Incorporated Message Board

  • jsblvbjb jsblvbjb Oct 23, 2013 9:57 AM Flag

    Problems found with Adam Feurstein's Analysis of Insmed's Phase 3 data

    "Generally speaking, efficacy analyses conducted on ITT or mITT patient populations are more conservative, more stringent and more reliable than analyses done with per protocol patient populations. When you omit patients from a study analysis, bias can creep into results."

    Absolutely false, Adam! Only patients that complete the study protocol can give an accurate measure of efficacy at the end of the study period. The great majority of patients on both sides of the equation completed the study. Apples to apples is the only scientific way of coming to accurate results. Patients that only take the drug for one month, then drop out for whatever reason, cannot generate accurate "endpoint" results whether its Tobi or Arikace. Also, since Arikace is experimental, a patient would be more likely to quit over a side effect than when using a drug they're familiar with.

    "Look at the chart again and notice that Insmed relies on the per protocol patient population for the analysis of the study's primary endpoint. Why not use the more stringent mITT patient population? Insmed doesn't explain."

    I answered this question already above!

    "Key Arikace efficacy secondary endpoints NOT reported by Insmed include:
    -- Time to and proportion of subjects experiencing a pulmonary exacerbation.
    -- Time to first antipseudomonal antibiotic treatment for pulmonary exacerbation.
    -- Time to and number of hospitalizations. "

    Zacks reported that Insmed will report these endpoints by December. Hospitalizations was not an issue, other than for one patient of the Tobi arm.

    "In fact, Insmed analyzed four different secondary efficacy endpoints from the Arikace study using the mITT patient population, according to the poster presented this weekend. The only endpoint using the per protocol patient population was the primary."

    Why did you only include the sputum density chart, Adam? It's a completely different analysis point than FEV1. The other charts break for Arikace, too!

    Sentiment: Strong Buy

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