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FDA approves Sareptas Srp901 for the whole population, page-24

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    Yes, I'm confused too.

    I've read the detailed articles on the Sarepta approval and the FDA definitely pushed the envelope to get it approved. There were only minor signs of improvement, and a surrogate end point definition had to be stretched to get it across the line. Two senior FDA officials recommended the drug application's rejection. It came down a chemical marker, which the fda asserted could indicate a potential benefit.
 
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