Steve Davis, Acadia CEO

Aca­dia preps for bat­tle as the FDA re­jects a po­ten­tial block­buster ap­pli­ca­tion

The rolling ar­gu­ment about whether or not the FDA is get­ting tougher this year just got a fresh spur in fa­vor of the af­fir­ma­tive.

Just a few weeks af­ter the FDA sig­naled trou­ble for Aca­dia’s block­buster pitch to ex­pand the de­men­tia fran­chise for Nu­plazid, the biotech is back this morn­ing with news that the FDA has hand­ed over a CRL. And ex­ecs seem ready to throw down over the re­jec­tion with reg­u­la­tors as soon as pos­si­ble, as a slap­down here would like­ly re­quire at least one ma­jor tri­al to cure the FDA’s ob­jec­tions.

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