Pressure builds for Celgene payout as BMS faces possible liso-cel delay 

With 11 days to go before liso-cel’s PDUFA date, FDA has yet to inspect one of two cell therapy facilities where the Bristol Myers Squibb CAR T is being manufactured, signaling a possible delay and putting further pressure on a CVR payout tied to the pharma’s acquisition of Celgene.

Samit Hirawat, EVP and CMO of global drug development at Bristol Myers Squibb Co. (NYSE:BMY), disclosed on the company’s 3Q20 earnings call that while the cell therapy manufacturing facility it is using to make lisocabtagene maraleucel in Washington has been inspected, an inspection has yet to be scheduled at a facility in Texas. Hirawat attributed the delay to travel restrictions and FDA’s measures to keep its staff safe during the COVID-19 pandemic...