Bris­tol My­er­s' $9 Cel­gene CVR is tee­ter­ing on the brink of dis­as­ter as the FDA de­lays the liso-cel ap­pli­ca­tion yet again

The CVR ($BMYRT) tied to Bris­tol My­ers Squibb’s big Cel­gene buy­out took one more step right to the brink Mon­day af­ter­noon.

As some an­a­lysts had fret­ted about, the FDA was un­able to sched­ule an in­spec­tion of one of the man­u­fac­tur­ing sites that was to be used for the pro­duc­tion of liso-cel, their CAR-T picked up in the buy­out, which was orig­i­nal­ly de­vel­oped by Juno. As a re­sult, Bris­tol My­ers re­port­ed to­day that the FDA will not meet its PDU­FA date to­day.

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