“Given the timeline to start the study, produce the study reports and refile, we believe the delay is at a minimum one year and up to three years if management must redo all animal work,” Harrison said in a note to clients.
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Celgene recently filed for Food and Drug Administration approval of ozanimod in relapsing multiple sclerosis, but the FDA wouldn’t green light the plans, contending there were insufficient sections in the drug application, reports Emma Court for MarketWatch. Celgene will likely need to re-run preclinical toxicology studies, further delaying the re-filing by at least a year.
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