'A missed op­por­tu­ni­ty': The biggest take­aways from the FDA's un­der­whelm­ing gene ther­a­py hear­ing

Re­searchers and ex­ec­u­tives hop­ing that the FDA’s two-day hear­ing on gene ther­a­py would of­fer a clear di­rec­tion for the field’s fu­ture came away dis­ap­point­ed.

For 16 hours, the agency lis­tened to pre­sen­ta­tions and de­bat­ed every­thing from AAV-dri­ven can­cers in mice to how con­cerned we should be about strange MRI re­sults in pa­tients giv­en di­rect in­jec­tions in the brain. But few firm con­clu­sions or rec­om­men­da­tions ever ar­rived.

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