Bristol Myers Squibb Receives a 'Refuse to File' Letter for an Experimental Cancer Therapy on a Deadline
Critically ill patients with multiple myeloma will need to wait a lot longer for an experimental new cancer therapy from Bristol Myers Squibb (NYSE: BMY) and bluebird bio (NASDAQ: BLUE) than they had expected. The FDA has refused to file a new biologics license application that would have made idecabtagene vicleucel (ide-cel) available as a treatment for patients who have run out of options.
Ide-cel was one of three potential blockbusters in Celgene's late-stage pipeline that Bristol Meyers Squibb wasn't willing to pay for up front when it purchased the company. Instead, Bristol issued tradable contingent value right (CVR) shares (NYSE: BMY.RT) that it will redeem for $9 apiece in the event all three drug candidates earn FDA approval before predetermined dates. Unfortunately for their holders, the CVRs will expire without any payout if just one candidate fails to earn approval on time.
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Source Fool.com
