FDA Requests More Changes On The Clinical Hold Of CEL-SCI's Head And Neck Cancer Trial
CEL-SCI Corp disclosed in an SEC filing:
On June 28, 2017 CEL-SCI Corporation received a letter from the U.S. Food and Drug Administration (FDA) in response to CEL-SCI's most recent June 2, 2017 submission regarding the clinical hold imposed on the Company's Phase 3 head and neck cancer study with Multikine (Leukocyte Interleukin, Inj.) Investigational New Drug (IND).
In this most recent letter, the FDA requested that three additional changes be made to the Multikine Investigator Brochure (IB) that CEL-SCI submitted to the FDA on June 2, 2017.
On June 28, 2017 CEL-SCI Corporation received a letter from the U.S. Food and Drug Administration (FDA) in response to CEL-SCI's most recent June 2, 2017 submission regarding the clinical hold imposed on the Company's Phase 3 head and neck cancer study with Multikine (Leukocyte Interleukin, Inj.) Investigational New Drug (IND).
In this most recent letter, the FDA requested that three additional changes be made to the Multikine Investigator Brochure (IB) that CEL-SCI submitted to the FDA on June 2, 2017.