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4-Traders Homepage  >  Equities  >  Nyse MKT  >  CEL-SCI Corporation    

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CEL SCI : Submits FDA Response for Its Phase 3 Head and Neck Cancer Trial

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06/15/2017 | 08:03pm CEST

By a News Reporter-Staff News Editor at Cancer Weekly -- CEL-SCI Corporation (NYSE MKT: CVM) announced that it has responded to the U.S. Food and Drug Administration's (FDA) most recent communication from May 2017 about the clinical hold imposed on the Company's Phase 3 head and neck cancer study with Multikine* (Leukocyte Interleukin, Inj.) (see also Oncology - Head and Neck Cancer).

The hold issues addressed in the FDA communication were that the study's Investigator Brochure (IB) and the "Dear Investigator" letter need to be revised. Specific deficiencies and their locations in each of the documents were identified, and directions were given as to the specific information that should be included in the revisions of these documents. CEL-SCI revised the documents exactly as directed by the FDA. If the FDA finds the revisions made to the two documents to be satisfactory, CEL-SCI is hopeful that all of the clinical hold issues have now been addressed, and the FDA will consider lifting the clinical hold.

As of September 2016, nine hundred twenty-eight (928) head and neck cancer patients have been enrolled and have completed treatment in the Phase 3 study. In accordance with the study protocol, the FDA's instructions, and subject to the clinical hold, CEL-SCI continues to follow these patients.

Keywords for this news article include: CEL-SCI Corporation, Head and Neck Neoplasms, Oncology - Head and Neck Cancer, Government Agencies Offices and Entities.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC

(c) 2017 NewsRx LLC, source Health Newsletters

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CEL-SCI Corporation Technical Analysis Chart | US1508375086 | 4-Traders
Managers
NameTitle
Geert R. Kersten CEO, CFO, Director & Chief Accounting Officer
Patricia B. Prichep Secretary & Senior Vice President-Operations
Eyal Talor Chief Scientific Officer
Alexander G. Esterhazy Independent Director
Peter R. Young Independent Director
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