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Sarepta Therapeutics, Inc. Message Board

  • zoeykittles zoeykittles Jun 2, 2013 12:34 PM Flag

    Tredleon, Ruby and longs...

    As I stated on Friday, it appears that the drop is a bit of an overreaction. Aside from the volume being very low for a sell off (I would have expected easily over 2-3+ million shares if investors were running for the hills. I think big money was shaking the trees in hopes of stealing cheap shares from weak hands. There are many weak hands on this board), it would seem this "delay" really isn't much of a delay at all. Chris does not appear to know how and when the FDA will respond. They may respond in a few days, weeks or months. We do know that the parents have met with the FDA at least 3 times and they said their meetings went extremely well. To me that says the FDA is going to move quickly. I know Jenn McNary has been leading the charge and we know that Austin does not have much time so if there was a belief the FDA was going to drag their feet, I am sure the parents would not have been as encouraged.

    Additionally, isn't the debate between longs and shorts on whether the FDA will recommend that SRPT file for accelerated approval? I never got the impression the shorts were betting that SRPT would get accelerated approval but that it would take until 2014 to receive approval. If the FDA recommends filing for accelerated approval, the stock should explode as it will become de-risked . Furthermore, If SRPT files for accelerated approval, we could assume the following:

    1. The FDA recommended that SRPT file
    2. The FDA will approve eteplirsen (I can't imagine the FDA would recommend filing, having met the parents several times only to deny)
    3. Eteplirsen would be the first to the market and pretty much become far and away the market leader right now

    Again, as I have stated, the "binary" event for SRPT is whether the FDA recommends they file for accelerated approval. This could come at any time. This does not mean follow up meetings with the FDA won't occur such as how the FDA wants SRPT to provide the information, roll out the drug or set manufacturing guidelines

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    • It's is very evident that Chris's expectations changed after his last interaction with the FDA. Wether that change was due to a delay from the FDA or miscalculation on Chris's part (in regard to timing of upcoming events) remains unknown. His expectations are what we base our expectations on since he is directly involved and since we don't know the outcome of this binary event yet. It is important to know the exact source of this change of expectations. If its the FDA (if for example they set certain timeline expectations and then changed them) then this indicates a delay and a sense of hesitation on their part and thus a higher risk that they might not recommend AA. You make a point that this about accelerated approval regardless of "timing" or "delays". I differ in my opinion because I think timing, or more importantly a change in timing of the FDA's part, is our biggest clue on wether or not they are going to recommend AA. Everyone seems to zone in on one aspect of this whole approval process and miss the big picture. So lets not forget originally Chris indicated his follow up with FDA was in June and now he is saying August after his last talk with the FDA. You disregard this info as unimportant, since you write it off as Chris's' misunderstanding and not a delay/hesitation on part of the FDA. I try to keep both possibilities in mind which will give me a better perception, and lack of bias, and i will be able make the smarter decision in the end. I advise you to do the same.

      Sentiment: Buy

    • Zoey; a well reasoned logical post. Thx

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