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Sarepta Therapeutics, Inc. Message Board

  • usagary1 usagary1 Mar 21, 2013 8:07 AM Flag

    SEEKING ALPHA CAUGHT MY EYE ON A STATEMENT''UNDER FDA REVIEW FOR EARLY APPROVAL''??

    Sarepta (SRPT)

    Sarepta focuses on the discovery and development of RNA-based therapeutics for the treatment of rare and infectious diseases. Its lead product candidate is eteplirsen, designed to treat Duchene muscular dystrophy (DMD). The drug is currently under review by the FDA for accelerated approval, and a decision is expected by the middle of this year.

    Valuation is the name of the game in speculative Biotech, and finding companies that have high upside as well as mitigated risk is not only a challenge for investors, but big pharma as well.

    One such company is Sarepta, and many reading this article are undoubtedly familiar with its lead drug eteplirsen and its clinical success treating DMD. The drug alone makes Sarepta a very attractive candidate to be bought out. Recent struggles by Glaxo-Smith Kline's (GSK) drug drisapersen highlight both the desire and difficulty that big pharma is having trying to enter this space. One additional caveat to consider is that most Americans have some knowledge of DMD as a disease, if treated, would garner a tremendous amount of positive Press coverage. Companies like Pfizer and Bristol-Meyers Squib (BMY) could see eteplirsen as a way to bolster their reputations as well as their bottom line.

    Another reason that I think an acquisition bid could be in order for Sarepta is because when a company has tremendous stock appreciation in a short amount of time or a dramatically positive event, sometimes management does not have experience in executing the "next step". Sarepta's management was previously operating as a developmental company versus one ready to go to the next level. At minimum, bringing in some high profile resume's or the completion of a partnership would seem reasonable, if not a full buyout.

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    • Do you really give any credence to a SA article? The timing of their statement makes absolutely no sense - there will be no decision by the "middle of this year". The company will decide in Q2 whether to pursue an AA at which point they will have to prepare the NDA, which will take 2-3 months, so they will file the NDA in Q3, and a decision from the FDA would take at least 4-6 months - the priority review guidelines for a response are 6 months (instead of the usual 10), so even if you hope for the FDA to push the envelope on the review process, you are still looking at the end of the year before a formal decision is made. Why would you want to pull sloppy statements from a pseudo-analyst as evidence that something is going to happen well before the timeline put forth by management?

      • 1 Reply to tredleon
      • the CEO has publicly explained what he thinks the forward schedule is at least a few times

        1. FDA initial submissions by 2012 year-end

        2. FDA/srpt back and forth until P2 meeting

        3. P2 meeting by end of Q1 (we have strong reason to believe it is this week), NOT next week, based on CEO's schedule)

        4. Srpt will discuss FDA view on Srpt filing an AA app during meeting

        5. at some point after meeting, Srpt will publicly disclose its forward plan based on meeting results

        6. the decision of Srpt to file or not file AA app comes off the P2 meeting, not off the next meeting scheduled for Q2

        7. results of Q2 meeting on manu, etc. will impact, in part, whether AA app would be approved or not by FDA later in 2013 or early 2014

        needless to say, right now today, FDA and Srpt, based on the process since january 1, both know whether Srpt will be filing an AA app (the meeting is almost perfunctory at this point)

        the question that remains is how long after meeting will Srpt disclose its intentions

        most assume it will be at least 30 days after the meeting, based on the view that the fda will take 30 days with the minutes and that Srpt will not make any disclosures until after it gets the minutes

        I do not believe this to be true for several reasons ... fda does not always take 30 days, as it can be done sooner ... and if signal from fda at the meeting is clear, Srpt may have a disclosure issue waiting for the minutes when it already knows exactly how it will proceed

        in any event, I think the company speaks by no later than monday, april 22, but it could be sooner, much sooner

        we just don't know

        the fact that the stock is 30ish evidences just how much we all just don't know

        if everybody thought the fda was amenable to the AA app, where would the stock be right now?

        I say far away from 30ish

        its a nail biter for the immediate near-term

    • Same here

 
SRPT
38.91+0.12(+0.31%)Apr 23 4:00 PMEDT

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