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Sarepta Therapeutics, Inc. Message Board

  • simp08801 simp08801 Apr 2, 2013 7:23 AM Flag

    Anecdotal Evidence on Timing of FDA update is Very Recent and Very Clear

    once again, facts get in the way of distortion if you simply review 100% public evidence

    public evidence on whether a-4658 continues to work is very recent and very clear

    and public evidence on when you will hear on the FDA update is just as very recent and very clear

    HIDING IN PLAIN OPEN VIEW ...

    search "March 27, 2013 FierceBiotech Garabedian" to find the most recent public comments of the Srpt CEO on this exact issue

    1. based on the Srpt's publicly known schedule, the LATEST the FDA P2 meeting could have been was Thursday, March 21 (it could have been March 20 or 21 too, but lets assume the latest)

    2. The following Srpt CEO quotes from the March 27 FierceBiotech article were made by the CEO no later than March 26:

    "We have not disclosed when we plan to announce our post-FDA meeting feedback... We've simply indicated it would take place after we received meeting minutes or approximately 30 days after the actual meeting."

    3. Based on just the public facts set forth in 1 and 2, it seems a certainty that the absolute LATEST date that the CEO will provide his FDA update is Monday, April 22 (and if you use precise 30-day math, you will see that the latest date could also be 5 days sooner than that)

    4. But there is another equally important fact that appears even less widely known. And that fact is that the FDA meeting process takes NOT EXCEEDING 30 days. There are known instances where companies and the FDA have agreed on meeting minutes in less than 2 weeks.

    Thus, fact #4 is the dynamite stick wildcard that the day traders, momo players and shortsellers will themselves be flicking a match at, and will be (currently are) attempting to induce retail longs to flick a match at

    I personally believe that trying to "time" this impending mega binary event could be a very very very costly mistake

    especially since there is other binary news pending from Srpt on 74 week trial results

    the evidence on those 74 week results is aso HIDING IN PLAIN OPEN VIEW

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • As for the anecdotal evidence. We all know that the FDA will not take that into account. I would think that whoever makes these anecdotal statements including "cardiac benefit" will lose credibility fast when all scientists, Sarepta and the FDA know that this drug cannot be delivered to the heart. I would think these statements have the opposite effect. If you know that person tell her/him to stop making up statements, it doesn't help Sarepta or anyone else.

      • 3 Replies to prosci74
      • Any scientist that knows the PMO cannot be delivered to the human heart is by definition, NOT A SCIENTIST!

        There are expectations based on primate testing delivery to the heart will be limited,

        Furthermore the ability of the kids to perform more vigorous exercise, may also improve the heart muscles. Or the corollary could also be true.

        Hopefully Sarepta has some natural history data to compare the cardiac function to.

        We learn through testing and in the end only the testing in humans gives the final answers, if this was not the case there would be no need to do human testing.

        Sentiment: Buy

      • Prosci,
        didn't management disclose in Australia that the twins who were excluded from the study once they lost that ability to walk, had shown "stabilization" of both heart and lung function, thus implying some sort of actual improvement from what would be expected due to the normal course of
        the disease? I actually bought an additional chunk on that particular news, so I'm pretty sure something along that line was made public. ANY improvement in heart/lung should be considered meaningful as far as I'm concerned.

      • I think there has been a study or two that showed the PMO does seep into the heart tissue a bit over an extended period of time. But I also think that the heart functioning may improve due to the improvement in other muscles tangentially involved.

    • jstevenskarbek@ymail.com jstevenskarbek Apr 2, 2013 9:49 AM Flag

      sarepta has fda ecision will release any day now

    • My evening vote for post of the morning!

    • As indicated in my previous post, I think Margaret Hamburg's schedule controlled the meeting date. She met with DMD parents on March 11 and spoke to the Mass Bio conference on March 15. Was her meeting with the parents for purposes of her March 15 speech where she mentioned the parents' meeting or was the meeting with the parents a business meeting to gather parent feedback about how they felt about Eteplirsen? I think it was the latter. It related to the decision on Eteplirsen. It was the last piece of the puzzle FOR the FDA in preparation for the meeting with the company on AA or BT and related to the need for a confirmatory trial. The meeting with Sarepta occurred after the March 11.

      So the meeting with Sarepta could just as well have been before Dr. Hamburg's March 15th speech. She said in her speech: "We recognize the need to find the most meaningful and effective ways to help SPEED the availability of new products for people in need...Patient reported outcomes are a type of data the FDA is increasingly looking at, along with the patient perspective more broadly....Earlier this week I had a powerful meeting with patients and patient families about what needs to be done to get innovative and life-saving medicines to them FASTER". (Emphasis supplied). It doesn't sound like the FDA wants foot dragging by anybody. Why would they have waited another week if they could have made their decision after the meeting with the parents?

      Sentiment: Strong Buy

      • 1 Reply to shimp41
      • Looks to me that the Hamburg meeting with parents was their final push before the Sarepta meeting. Obviously FDA is not allowed to discuss details about specific drugs. The parents just wanted to make their points clear. Now you do know that the FDA is lookign at data before any decisions are made regardless of what parents want. No point in counting the days, the end of P2 meeting took place a while ago, so notes should be out within 2 weeks or so.

    • agreed simp, but srpt has 4 days to release mat'l news; notice cg said "it would take place"

      that's a lot of wiggle room

      take your schedule + 4 days for the absolute latest

      go back to oct; remember srpt leaked the results themselves when they updated their webisite by accident on a thursday

      well, gues what? the pr announcing the results came out on the following tuesday
      xactly 4 tradings days after srpt rec'd the results

      they have a history of waiting 4 days

      after all this, i can deal with it, but it will be virutally impossible to sit on these results for too long

      Sentiment: Strong Buy

    • You are very right,it is all there if you look good.Most just want to guess .I find that we will see some of this much sooner than you think.

 
SRPT
21.78-0.75(-3.33%)Sep 19 4:00 PMEDT

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