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Earlier this week, the Food and Drug Administration released documents that reveal a schism within the agency regarding its approval of Vyondys 53, a medicine to treat boys with Duchenne muscular dystrophy made by Sarepta Therapeutics (SRPT).

The 2016 approval of the company’s first drug, Exondys 51, also for Duchenne muscular dystrophy, was controversial because it was approved on very early data. There was a voluble debate within the FDA over whether the treatment actually worked. Now, this saga seems to be repeating itself with a new drug.


STAT reporters Matthew Herper, Adam Feuerstein, and Damian Garde discussed what was learned this week during a recent episode of STAT’s biotech podcast, “The Readout LOUD.” Here’s a lightly edited version of  their conversation:

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