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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.