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Sarepta Therapeutics, Inc. Message Board

  • simp08801 simp08801 Apr 16, 2013 7:59 AM Flag

    lunacy is the word

    I am still banging my head, this time against shower wall

    lemme get this straight ...

    if you are having a EoP2 meeting where you are fishing for an AA app wink, then by definition, your total thrust (after safety) is to show your surrogate marker is a valid predictor of clinical outcome, and then to show that some of that clinical outcome has already happened

    so you submit a data package to fda in december and then you have back and forth with staff for a few months on that package, culminating in a meeting in march

    which meeting, from everything you can read about EoP2 meetings, is generally supposed to be a summary of what has already happened in the last few months of back and forth

    and what actually happens at this meeting?

    the fda appears to ask you to now provide it literally the exact information that even my dead dog and dead cat would have assumed was the actual foundation of what you submitted in the first place

    I loved my dead dog and cat

    I do not care about upgrades, downgrades or new articles

    this seems wayzy crazy to me folks

    and the only possible mildly sane reason I can conjure for this lunacy is that the FDA has figured out that in this specific instance, a positive wink on accepting an AA app better be gorilla glued to a later AA approval

    because whether the fda likes it, or not, this is how everybody will interpret the AA filing

    I am now going to find out which planet translates 90 earth days in 15 days, and I am moving there there this morning

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    • Your critique is a little simplistic - from the commentary, it appears they went into the meeting looking to show detail behind how the dystrophin biopsy measurements were taken and the related tests to show why the dystrophin being produced would be functional. You can bash this focus, but in a disease that is defined by the lack of dystrophin production, the idea that they would have to extensively document why dystrophin production is a valid surrogate endpoint seems a little ridiculous. Obviously, the jury is still out on what level of dystrophin production will produce "clinical" benefit (the measurement of which is fraught with its own issues, depending on the age of the boy and stage of disease), but as he stated in the call, the 30%-50% levels they were achieving are well beyond what some Becker's patients live with. Assuming in this meeting they dealt effectively with the dystrophin measurement issues and the functional issues, then simply summarizing why dystrophin production is THE ONLY valid surrogate marker should be easy and tie a nice bow around it for the FDA to move forward with an AA filing.

    • viper18411 Apr 16, 2013 12:24 PM Flag

      woulda,shouda,couda,either you beleive in the drug or you don' sense cryin over spilt milk,everyone makes a mistake.i believe we will get aa and am holding the course,if you don't sell and be gone.

      Sentiment: Strong Buy

    • FDA is stuck between a rock and hard place...on one hand you have promising clinical data but just on 12 kids, what happens if FDA approves the drug based on such little data and God forbid the drug will have some serious adverse effects in some boys, on the other hand rejecting AA is a PR nightmare... so FDA did what government agency usually good at, they drug their feet, hoping another 3 months may or may not bring more clarity, or I should say tip the scale one way or another

    • agree simp; this should have all been wrapped up before the march meeing

      here's a theory that no one will want to hear

      the fda doesn't want to appear to be responding to publc pressure or caving to public pressure

      Sentiment: Strong Buy

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