FDA slams bluebird and Bristol Myers with a surprise RTF on ide-cel, but execs insist they can overcome setback quickly
Bristol Myers and their partners at bluebird have been slammed with a refuse-to-file letter from the FDA for their closely watched myeloma drug ide-cel (bb2121). And the move early Wednesday threatens to derail a $9 CVR Bristol Myers offered Celgene investors when they bought out the company.
According to a terse statement from the partners, the agency spurned the application because it includes a faulty section on CMC which “requires further detail to complete the review.” No other data are required to complete the application, they add.
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