FDA slams blue­bird and Bris­tol My­ers with a sur­prise RTF on ide-cel, but ex­ecs in­sist they can over­come set­back quick­ly

Bris­tol My­ers and their part­ners at blue­bird have been slammed with a refuse-to-file let­ter from the FDA for their close­ly watched myelo­ma drug ide-cel (bb2121). And the move ear­ly Wednes­day threat­ens to de­rail a $9 CVR Bris­tol My­ers of­fered Cel­gene in­vestors when they bought out the com­pa­ny.

Ac­cord­ing to a terse state­ment from the part­ners, the agency spurned the ap­pli­ca­tion be­cause it in­cludes a faulty sec­tion on CMC which “re­quires fur­ther de­tail to com­plete the re­view.” No oth­er da­ta are re­quired to com­plete the ap­pli­ca­tion, they add.

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