Celgene works to calm down anxious investors, promising to re-file ozanimod at the FDA in early 2019
For weeks now, analysts have been fretting over the future of Celgene’s $CELG multiple sclerosis drug ozanimod. Turned away at the FDA’s front door with a refuse-to-file letter, their attention focused on an active metabolite of the drug and speculation over whether or not the big biotech would be forced to run a new human study to satisfy regulators that would set them back years.
This morning, Celgene execs went to some pains to explain that the delay would stretch out only to Q1 2019 as researchers undertook some bridging non-clinical studies of the drug. No lengthy human studies would be needed, the company added. And they would hustle along a European application alongside the FDA pitch in the first few months of next year.
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