FDA decision on Sarepta’s Duchenne gene therapy could come earlier than expected
Sarepta Therapeutics’ chief scientist suggested that the FDA was ahead of schedule in reviewing the company’s application to expand the label of its Duchenne muscular dystrophy gene therapy Elevidys.
“We’ve been informed by the agency that they will be sending us the draft labels sooner than they had previously indicated,” Sarepta’s top scientist Louise Rodino-Klapac said during an earnings call Wednesday afternoon.
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