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Sarepta Therapeutics, Inc. Message Board

  • crossmebaby123 crossmebaby123 May 30, 2013 5:38 PM Flag

    FDA should be put to jail for their waiting on this.. Should be a no brainer

    in my eyes. Now i guess june will be one of those months where srpt sleeps in thte 30s. I will wake up in july and see where we are at

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    • What part of avoiding the delay entailed by a Phase III Trial is lost on you? Accelerated Approval does NOT excuse the FDA from due diligence, in fact it requires that the FDA be extremely cautious in reviewing information that supports any application for AA.

      Beyond that, until facilities are ready, inspected and approved it would be completely impossible for Sarepta to even begin to meet the anticipated demand for this treatment - even at full capacity they are going to have to have some method of prioritizing which boys will be first in line. A late Q3/early Q4 launch was always a best case scenario and nothing that has happened to date has (or can) change that.

      None of what was discussed in yesterday's presentation indicates that the FDA is being anything but supportive and prudent in their actions. There simply are no "no brainers" in this arena, nor should there be.

      Sentiment: Strong Buy

    • You didn't really expect any accountability in Obama's government did you?

      Our government is the largest it has ever been in history. Taxes also at an all time high. You don't really expect the government to be more responsive just because of that do you? Nahhhhhhh.

    • I think the market will get a huge surprise from FDA this time around. The white paper SRPT submitted contains no new information, it's a collection of all the latest research. I can assure you FDA already reviewed all those research before SRPT's submission. It's merely a formality. What's new to FDA is the 74-week data and SRPT's interpretation. Considering FDA already has all previous data including 36- and 48-week, I don't think it will take FDA more than a few weeks to come to the conclusion that the treatment effect is durable and safe, in particular.

      IMHO, FDA will come out by end of June to tell SRPT they can go ahead file for AA and the meeting in Q3 will go over in detail what expectation they have on manufacturing and P3 design. Traders who sold their June and July calls will regret big time when this happens.

    • Can parents push FDA? Do they ? They can call Obama for help..

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