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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”