In re­ver­sal, Sarep­ta to face FDA’s pan­el of out­side ex­perts on Duchenne gene ther­a­py

Sarep­ta now will have a pub­lic hear­ing with the FDA’s pan­el of out­side ex­perts on its Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py, it said Thurs­day af­ter­noon. The an­nounce­ment comes just two weeks af­ter Sarep­ta said the FDA told the com­pa­ny it had no plans for an ad­vi­so­ry com­mit­tee meet­ing.

A date has not been set for the ad­comm meet­ing, but it will be held some­time be­fore the FDA’s dead­line of May 29 to de­cide whether or not to grant the ther­a­py ac­cel­er­at­ed ap­proval. In an in­vestor call, Sarep­ta CEO Doug In­gram em­pha­sized that the de­ci­sion was not re­lat­ed to any new da­ta or analy­sis.

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