In a sudden about-face, the Meals and Drug Administration will maintain a gathering of out of doors specialists to think about whether or not or to not approve Sarepta’s experimental gene remedy for Duchenne muscular dystrophy.
The announcement Thursday comes simply weeks after the corporate mentioned the FDA had instructed it an advisory panel assembly to assessment the remedy, referred to as SRP-9001, wouldn’t be vital. The choice to assessment Sarepta’s gene remedy with out enter from outdoors specialists stunned some analysts and affected person advocates.
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