Sarepta Pressured FDA On Eteplirsen Due To ‘Dire’ Finances, Gave Investors Rosier Picture

Emails reveal company wanted timelines and approval commitments from FDA toward the end of the eteplirsen review, saying it might not be able to continue studies; at the same time, Sarepta was telling investors it had 12 months of cash on hand.

Sarepta Therapeutics Inc. tried using company financial problems to push FDA to complete the final stages of the review of the Duchenne muscular dystrophy drug Exondys 51 while also telling investors there was enough operating capital to continue for a year.

The move did not work because FDA's approval was delayed several months after officials appealed the final decision made by Center for Drug Evaluation and Research Director Janet Woodcock

More from Approvals

More from Product Reviews