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 nonclinical and clinical pharmacology – which the company said "were insufficient to permit a complete review" – and it does not appear that another pivotal trial will be needed to support the NDA
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