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Sarepta Therapeutics, Inc. Message Board

hwsimpsonshero 8 posts  |  Last Activity: Jul 11, 2016 10:20 AM Member since: Jul 17, 2009
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  • hwsimpsonshero hwsimpsonshero Jul 11, 2016 10:20 AM Flag

    Thig, the CDER made its decision based on what it believed; not based on spite. I get that it's hard to accept that, but it's the truth. Thankfully, Janet Woodcock has the ultimate say, and so long as dystrophin is present, it's a fair bet that she'll approve eteplirsen with AA.

  • hwsimpsonshero hwsimpsonshero Jul 11, 2016 10:07 AM Flag

    The world clearly does not know it. If it did, the FDA wouldn't have slammed the drug, and we wouldn't be in the midst of a delay. Hyperbole such as yours has never helped the stock.

  • Reply to

    thoughts as each day goes by

    by johnny87778 Jul 7, 2016 12:32 PM
    hwsimpsonshero hwsimpsonshero Jul 7, 2016 3:25 PM Flag

    I don't think SRPT gets a CRL, but I also don't believe lack of news indicates the odds of that lowering each day. I think the quiet period and the fact that the company is interacting with the FDA is a shield from releasing dystrophin data immediately. Because the data will be made public when the FDA makes its decision. Why else have a quiet period? It makes no sense to impose a quiet period and then as soon as data comes, end the quiet period. That's just normal business that wouldn't require a quiet period. I also can't think of a single example dating back to 2009 where the FDA has requested new data from a company and then that company releases said data publicly. If anything, they simply send out a PR that the new data has been submitted per the FDA's specifications. But they don't include the data.

    I also don't think you can make the argument that they'd only release data if it was bad. Materially speaking, reasonable investors realize that good dystrophin data would also impact the share price, so if the data is going to be released, I'm of the opinion it will be released no matter what. But the quiet period tells me that it won't.

    I agree that if the dyst data is bad, the FDA would waste no time issuing a CRL as soon as they see it.

  • hwsimpsonshero hwsimpsonshero Jul 7, 2016 3:03 PM Flag

    Anyone with a brain knows that ESSENCE was going to be a placebo-controlled trial no matter what the outcome of eteplirsen's NDA is. The FDA wants a placebo controlled trial, and it behooves SRPT to get one started immediately. I don't think it's some sort of handshake agreement that it start now, and I don't think the FDA's decision is being held until ESSENCE starts. They'll decide independently of that.

  • Reply to

    option clues

    by marckot Jul 5, 2016 4:19 PM
    hwsimpsonshero hwsimpsonshero Jul 5, 2016 4:44 PM Flag

    The options market is all over the place. There are no clues to be found there.

  • Reply to

    IMO, no analyst report is worth reading right now

    by simp08801 Jun 28, 2016 8:39 AM
    hwsimpsonshero hwsimpsonshero Jun 28, 2016 12:53 PM Flag

    Another good point that kills this theory.

    One more thing to add: How many biotechs can anyone name that have released news related to additional data for an NDA after a delay has occurred due to the FDA requesting new data? My guess is none, which further cements the likelihood that SRPT has no intention of pr'ing anything about dystrophin, regardless of its numbers.

  • Reply to

    IMO, no analyst report is worth reading right now

    by simp08801 Jun 28, 2016 8:39 AM
    hwsimpsonshero hwsimpsonshero Jun 28, 2016 10:15 AM Flag

    100% agree with you.

  • Reply to

    IMO, no analyst report is worth reading right now

    by simp08801 Jun 28, 2016 8:39 AM
    hwsimpsonshero hwsimpsonshero Jun 28, 2016 10:15 AM Flag

    I don't agree that if D was bad, it would be pr'ed right away. I think the company could easily say that the quiet period interaction with the FDA provides them with a shield from pr'ing all info. This is not at all unusual with pharmas that are interacting with the FDA. That's why there are always so many surprises in Adcom briefing docs, for example. Most of them include things that investors were never aware of--in SRPT's case, that dystrophin was only 0.9%. They never pr'ed that, so I disagree that they'd suddenly pr the new numbers. I think no news is simply no news in this instance. I do, however, lean toward eteplirsen being given AA.

SRPT
57.83-3.14(-5.15%)Sep 23 4:00 PMEDT