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Insmed Incorporated Message Board

  • jsblvbjb jsblvbjb Nov 13, 2013 11:01 AM Flag

    Serapta's blow-up, AF's Mea Culpa

    The Street and Cramer should be really embarrassed! This is some of what Falsestein had to say after losing his readers/followers millions of dollars:
    "How did I get Sarepta wrong? Without a doubt, I have been a Sarepta supporter and a believer in eteplirsen. My biggest mistake: Having more confidence in the tiny, 12-patient eteplirsen phase II study than I should have.

    In my defense, I was clear about the higher regulatory risk facing Sarepta following the failure of GlaxoSmithKline (GSK_) and Prosensa's (RNA_) drisapersen phase III study. What I didn't anticipate was FDA "rejecting" eteplirsen before the drug was even filed.

    My worst-case scenario was Sarepta filing eteplirsen based on the phase II study, FDA reviewing the application but then rejecting the drug with a request for a confirmatory phase III study. I didn't anticipate FDA not allowing the early filing to happen at all. Tuesday's scenario was not something I thought would happen. Big mistake.

    I also allowed emotion and anecdotal evidence of eteplirsen's efficacy to cloud my judgment. I usually admonish investors for investing in a drug stock based on a personal story. I violated my own rule with Sarepta. "

    Sentiment: Strong Buy

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