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It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval

Approval By Year-End Required For CVR Payout To Celgene Shareholders

 
• By Mandy Jackson

Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.

Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copy space.
Time is running out for BMS to win liso-cel approval by a crucial deadline for former Celgene shareholders • Source: Shutterstock

Bristol Myers Squibb Company confirmed on 16 November what many analysts and investors feared was inevitable – that the US Food and Drug Administration was not able to inspect the second of two manufacturing sites for lisocabtagene maraleucel (liso-cel) in time to inform an approval decision, putting in jeopardy a payout to Celgene Corporation shareholders tied to on-time approvals of three new products under the two companies’ merger agreement.

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