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More Bad News: Celgene Reveals Refuse-To-File Letter For Ozanimod In MS

 
• By Mandy Jackson

Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.

stopping the Dominio effect

Celgene Corp. revealed more bad news it didn't need on Feb. 27 when the company said it received a refuse-to-file letter from the US FDA for the new drug application (NDA) for ozanimod in multiple sclerosis, which generally was seen as a sure thing based on Phase III data.

Celgene does not expect an extremely long delay in FDA approval, because the agency's refuse-to-file (RTF) decision was based on...

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