As FDA lifts clinical hold, CEL-SCI's long journey to approval marches on
With the news that the US Food and Drug Administration has lifted the clinical hold it imposed on CEL-SCI (NYSE: CVM), the company’s 35-year quest for a marketable product has moved one step closer to its goal.
The FDA stopped the trial of immunotherapy candidate Multikine (leukocyte interleukin), which involves 928 patients with advanced primary head and neck cancer, in September last year, after deviations from the study protocol were identified.
Founded in 1983, the Virginia, USA-based biotech firm is yet to receive regulatory approval in any of its clinical development programs.
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