The first big hurdle on the Celgene CVR arrives today. Can Bristol Myers clear a low bar in the middle of a pandemic?
Can the FDA approve a closely-watched drug in the middle of a pandemic?
We’ll find out today just how severely the pandemic has affected the FDA. A bevy of analysts have been following Bristol Myers Squibb’s progress with ozanimod and most are giving this drug high chances of success — provided there’s no last-minute hitch to get hung up on.
Ozanimod — or Zeposia, as it will be called if it makes it to market — was famously kicked back to Celgene after the biotech lamely failed to put together an application worth in-depth consideration at the FDA. Celgene then took another 2 years to prep for an FDA-worthy application, which Bristol Myers picked up in the expectation that it could drive the multiple sclerosis drug over the finish line.
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