An FDA in­spec­tion rais­es ques­tions about Bris­tol My­ers Squib­b's liso-cel fa­cil­i­ty and the CVR, but an­a­lysts urge cau­tion

For months, spec­u­la­tion over Bris­tol My­ers Squibb and its $9 Cel­gene CVR has fo­cused on whether the FDA would be able to in­spect the Big Phar­ma’s cell ther­a­py plant in Texas in time to ap­prove their ‘liso-cel’ can­cer ther­a­py. But on Fri­day, the agency post­ed a doc­u­ment to its web­site an­nounc­ing that it had looked at the com­pa­ny’s oth­er liso-cel plant in Wash­ing­ton and found prob­lems there, in­clud­ing over ster­il­iza­tion pro­ce­dures.

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