Sarepta's Duchenne Treatment Likely Making Progress At FDA
This article was originally published in The Pink Sheet Daily
Data in advisory committee briefing addendum judged major amendment, requiring more review time.
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Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.
Agency won't say whether patient-focused drug development meeting and gene therapy conference were postponed because of COVID-19, but other meetings remain as scheduled.
Documents also show that Sarepta officials begged CDER director for approval on multiple occasions prior to the agency's September 2016 decision.