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.
Yes, I'm confused too. I've read the detailed articles...
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