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Sarepta Therapeutics, Inc. Message Board

  • usagary1 usagary1 Mar 11, 2013 11:19 AM Flag

    I think i understand now why dmd and jett meeting with fda today

    getting information and feed back before Sarepta's fda meeting that is more than likely this week as well.

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    • Agreed. It hit me this morning that no government agency would bring people in and then make a major surprise announcement (like breakthrough therapy designation as some of us had hoped). The FDA is seriously considering approving eteplirsen and the commissioner wanted to speak in person to leaders of the DMD community to see what they really think about the drug. This was still a very positive development.

      Sentiment: Strong Buy

    • As Dr Temple said in his presentation on AA-it's a team effort to get these drugs to those who need it and do so in a safe manner. In other words, the FDA tells them what's needed (in detail) and it's up to SRPT to provide necessary data. It's not a guessing game. Children's lives are at stake and anyone with any sense knows that.

    • You do know that discussions with FDA are never specific drugs, right? FDA is not allowed to discuss specific drugs with anyone except the company.

      • 1 Reply to prosci74
      • Prosci I think your statement is not completely true. 1) FDA is allowed to listen on specific drugs. 2) FDA is probably allowed to comment on non Confidential information. 3) If a company waived Confidentiality on some portion of information (unlikely) FDA could go much further in discussion.
        4) The FDA could answer a question such as, "Hypothetically, if a company had a trial of 12 patiients on a drug where there were about 2,000 treatable patients in the US and there were no safety issues and proof of surrogate endpoint and some proof of clinical efficacy would that be adequate for AA?" The answer from the FDA would not be "YES" or "NO." It might be more like "Quite Possibly" or in the rarest it might be "Probably impossibly!"

        Sentiment: Buy

    • Thant makes sense. How many SRPT patients will be represented today?

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