STAT Plus: Biotech veteran Chris Garabedian on Sarepta’s legacy and Biogen’s future at the FDA
This September marked the third anniversary of a pivotal moment in biotech. Back in 2016, Sarepta Therapeutics convinced the Food and Drug Administration to approve a treatment for Duchenne muscular dystrophy based on preliminary evidence from a tiny clinical trial.
Critics — and there were many — argued that Sarepta hadn’t done enough to prove that its drug could actually help patients. And there were countless tweets and editorials claiming that the FDA had set a dangerous precedent by approving the company’s medicine.
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