It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval
Approval By Year-End Required For CVR Payout To Celgene Shareholders
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.
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In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.
If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.