Farkas' FDA Departure Could Signal 'Imminent Decision' For Eteplirsen

Checks indicate that Dr. Ronald Farkas has left the FDA and his name no longer appeared in the HHS employee directory.

Oppenheimer’s Michelle Gilson said this was “a positive signal for eteplirsen approval” and maintained an Outperform rating on Sarepta Therapeutics Inc SRPT.

Farkas was the team leader for the review of eteplirsen and was “largely regarded as an antagonistic figure at eteplirsen's advisory committee in May,” Gilson noted. While Farkas was no longer listed in the HHS employee directory, his peers and DNP colleagues were still listed.

Related Link: Exclusive: Dr. Ron Farkas, Eteplirsen's Harshest Critic, Has Left The FDA

Eteplirsen Approval

“The nature of Farkas' departure is unclear, but it may signal an imminent decision,” Gilson mentioned. He explained that Farkas would not voluntarily leave unless the FDA had arrived at a final decision in its eteplirsen review. In case the FDA had already reached a decision on eteplirsen approval, Farkas' departure would unlikely change the outcome of the review anyway.

“We believe Sarepta has been negotiating with the FDA and educating the agency further to the specifics of DMD. Label negotiations and pivotal trial discussions are likely part of the dialogue,” the analyst wrote. She added that the FDA would likely make its decision public very soon.

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