A risky bet on a long-delayed CAR-T drug now faces a do-or-die deadline — where any slip can kill a $9 CVR
The deadline for an FDA approval of Bristol Myers’ CAR-T drug liso-cel is going right down to the wire.
The pharma giant put out the word today that the FDA is taking an extra 3 months to complete its review after the company provided another batch of info on the drug at the FDA’s request — which regulators deemed a major amendment.
That moves the goal line on a decision to November 16, just 6 weeks or so before the end-of-year deadline Bristol Myers established for Celgene investors as one of 3 positive marketing decisions that have to be won to get a $9 contingent value right, or CVR, {BMY.RT} payoff in their $74 billion merger.
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