New docs spotlight the FDA’s failed attempt to get Sarepta’s flawed Duchenne study retracted
One of the reasons why Sarepta $SRPT had such a hard time getting its Duchenne drug through the FDA rested on a published study that regulators had concluded was based on unreliable data that led to erroneous conclusions.
That 48-week study of Sarepta’s would prove to be a major sticking point for the FDA, spurring team leader Ellis Unger and FDA commissioner Robert Califf to outline their argument to the editor of the Annals of Neurology, Clifford Saper.
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