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Re: DewDiligence post# 222976

Saturday, 12/07/2019 6:02:28 PM

Saturday, December 07, 2019 6:02:28 PM

Post# of 257269
(BMY-R)—BMY presents Liso-cel CAR-T data in NHL:

https://www.businesswire.com/news/home/20191207005032/en

Based on results from TRANSCEND NHL 001, Bristol-Myers Squibb expects to complete the submission of a Biologics License Application to the U.S. FDA by the end of the year.

Liso-cel and bb2121 (#msg-152665844) are two of the three drugs that comprise the CVR from the CELG acquisition (#msg-145844551); they have approval deadlines of 12/31/20 and 3/31/21, respectively.

With BMY guiding to a BLA submission for Liso-cel by 12/31/19, FDA approval by the 12/31/20 deadline would seem to be doable.

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