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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.

Analysts anticipated earlier this month that approval would be delayed after BMS executive vice president and chief medical officer Samit...

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