Will FDA Virtually Inspect for Liso-cel US Approval? Celgene CVR Hangs in the Balance
On Wednesday, November 18, 2020, BMS stated at the Wolfe Research Healthcare Conference (transcript available from Seeking Alpha) that they are open to the possibility of a FDA virtual inspection for liso-cel’s Texas facility. As a reminder, the FDA missed their anticipated PDUFA date for liso-cel (Nov 16, 2020), due to an incomplete site inspection. Below, Celltelligence provides thoughts on the possible scenarios for the Texas facility’s inspection and how this may impact BMS’s CVR milestone.
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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.
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