FDA's Pe­ter Marks talks re­im­burse­ment of gene ther­a­pies that win ac­cel­er­at­ed ap­proval

LOS AN­GE­LES — “Every­one who thinks that the drug should be ap­proved, raise your right hand, and every­one who thinks the drug should not be ap­proved, raise your left hand.” Kei­th Won­na­cott, Lex­eo Ther­a­peu­tics’ VP of reg­u­la­to­ry af­fairs, queried a full au­di­ence about whether it thought Sarep­ta’s gene ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy should be grant­ed ac­cel­er­at­ed ap­proval.

Many raised their right hands, a few peo­ple raised their left. Most ab­stained, look­ing around the room to sur­vey their peers’ re­ac­tions.

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