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Sarepta Therapeutics, Inc. Message Board

  • wggm wggm Feb 23, 2013 8:17 PM Flag

    Anecdotal evidence and the FDA

    To what extent does the FDA look at the anecdotal evidence, eg. the videos of Max and the other children? I am tempted to think as scientists they just look at raw data, however, isn't Max's remarkable lack of deterioration pretty good evidence that etep is working (he couldn't open a milk bottle prior to enrollment, and now he is skiing). Even among those on this board who think etep won't get AA, is there any doubt the drug actually works?

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    • I listened to the webinar with Dr. Temple. One thing he mentioned is that the FDA talks to patients and caregivers because they know best how a medicine has affected them. He said this is very important input to the FDA, and that numbers aren't everything. Also he said that one or two members of the patient community serve on the review committee. The parents who serve on the committee will be very vocal I'm sure.

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