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Sarepta Therapeutics, Inc. Message Board

  • bionerd51 bionerd51 Apr 17, 2013 9:32 AM Flag

    Last Comment...

    There is NO delay. Let me put it another way. The additional data from the current dataset that the FDA is asking for is consistent for queries that occur after an NDA is filed. The FDA is signaling that they plan on approving eterplirsen once they have this data. Why do you think [rhetorically speaking] the families of DMD patients are ecstatic with what the FDA is telling them??

    Sentiment: Strong Buy

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    • Bio,.....After reading most of the reports and correspondence over the last couple of days I agree with you that there is no real delay, but I get this feeling reading between the lines that the request for more information by the FDA has not to do with 51, but the entire platform. Is it possible Chris is asking for across the board approval on the entire platform for all sequences? Is that possible? Is that why all of the parents are so enthused and encouraged?

      Sentiment: Buy

      • 1 Reply to fieldonthewater
      • Field, [Ha,Ha] Way too early for an entire platform approval especially with the low "N" size of the current phaseII trial. One of the analysts wrote that the fact that the FDA wants more data on Dystrophin lends them to believe that the FDA has no confidence that the PMO is acting on producing more dystrophin. Can you believe that? A covering analyst misinterpreting the FDA's call for evidence that dystrophin is a quality surrogate marker when in fact they want supporting documentation for dystrophin as a marker?? Unbelievable. As a Sarepta investor it's hard for shareholders to comprehend the lack of quality professional discourse on a simple request from the FDA. Something tells me we will hear something from the FDA before the 3rd Q.

        Sentiment: Strong Buy

    • I see no other way to interpret this request from the FDA, having soon reviewed all the possible data to review, they will give SRPT the green light to file AA, and everything will be in order for the most expedited AA process you have witnessed in biotech. The regulatory hurdles will be easily sailed over after this FDA review is completed.

      Sentiment: Strong Buy

    • I and hold.

    • the long term followers understand and are not sucked in to the BS posts. I know who adds value and appreciate it very much.

      Sentiment: Strong Buy

    • i am long, probably too long on this one.

      but it is a slight delay re: filing time etc, which would push an approval out. its prob only 90-120 days, but still its a delay in the regulatory timeline.

      what isnt delayed is SRPT's manufacturing ramp. that is still humming along.

    • This is the differences between good research and bad research ..and or very uneducated or unable to understand basic science at all.

    • Some would have us believe this is a delay, and that is false. The timeline to an application has always been some time in 3rd or even 4th quarter. The manipulation has been to make people believe the application/approval was coming in April. That false impression was created by and used by the short side for reasons that are obvious. The fact is that nothing has changed either the timeline or the chances of AA application or approval. Years end is and will remain my estimate of approval.

      • 7 Replies to mainlylobster
      • spot on red

      • You are correct that there is no substantive delay here, but the timing of approval was never going to happen in the 4th quarter, nor will it. My understanding of AA is that the confirmatory trial must be underway prior to formal AA - this is consistent with the FDA notes on using initial safety data from the confirmatory trial as part of the safety data available to the FDA as part of their approval process. Assuming the confirmatory trial starts in Q1, then they would have some initial safety data available in Q2, which is when you can expect AA. This is consistent with original expectations - they would file for AA in late Q3/early Q4 and even with priority review of 6 months, you are into Q2 of 2014 for formal AA.

      • Ah! The loser speaks his worthless opinion again! You have lost all credibility "MainlyRedneck". We laugh at you and your worthless attempts to redeem yourself .. LOL

      • I agree that it was always "scheduled" to be approved shortly before we were in a position manufacturing-wise to be able to sel it. No point in having the approval to soon before that. (And if there is a benefit, then I think they'll give it sooner!) At any rate there is a chunk of time between the last meeting a month ago and the expected approval date. How do you best fill that time?

        I think they determined that time is best filled by asking Sarepta to put together the tightest possible case for this new surrogate endpoint of dystrophin creation that will be used to approve the next exon drugs. And so that is what they are doing.

        We'll still be approved and selling the drug at the same time as always - but it's a good 8 or 9 months away based simply on how long it takes to manufacture the drug if nothing else. In the mean time we and the FDA are now about laying the solid foundation for the speedy approvals of the follow on exoon drugs.

        It's really pretty obvious to me - and I suppose that was explained as well to those 3 parents a week or so ago to their satisfaction and pleasure and hopeful anticipation of good things to come.

      • Red, what do you think of INO #$%$ or good)?

      • Red,
        You are absolutely correct as far as the over expectations for the March meeting. Chris stated over and over again that they were meeting with the FDA, for guidance for their application.
        As far as the chances of approval, I disagree with you. The biggest worry for eventual AA was the small size of the phase 2. The FDA, as indicated, by the couple of minor requests only, that the small number of boys in the study is not a problem for them.
        I believe their chances of AA approval, for this reason, is much better.

        Sentiment: Strong Buy

      • Red, We are speaking the same language. Set a false timeline and when that timeline can't be met create a false sense of failure. I'm surprised that many here are falling for it.

        Sentiment: Strong Buy

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