News Focus
News Focus
icon url

DewDiligence

11/16/20 5:33 PM

#235679 RE: DewDiligence #232008

FDA_unable_to_meet_BMY’s_liso-cell_PDUFA_date—(today)—due_to_COVID:

https://finance.yahoo.com/news/bristol-myers-squibb-provides-regulatory-212100907.html

The FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until the inspection can be completed. The application remains under review. The FDA did not provide a new anticipated action date.

BMY’s CELG-related CVR (#msg-145844551) is tanking again in AH trading.