Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

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

CEL-SCI CORPORATION
Mes dernières consult.
Most popular
  Report  
SummaryChartsNewsCalendarCompanyFinancials 
News SummaryMost relevantAll newsSector newsTweets
The feature you requested does not exist. However, we suggest the following feature:

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

share with twitter share with LinkedIn share with facebook
share via e-mail
0
06/15/2017 | 08:03pm CET

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

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on CEL-SCI CORPORATION
03:01pCEL SCI : Extends the Expiration Date of Series DD and Series EE Warrants Issued..
BU
02/15CEL SCI : to Present at 2018 BIO CEO & Investor Conference
AQ
02/13CEL SCI : NEW STORY CEL-SCI Corporation Reports First Quarter Fiscal 2018 Financ..
PU
02/13CEL SCI : NEW STORY CEL-SCI to Present Tomorrow at 2018 BIO CEO & Investor Confe..
PU
02/12CEL SCI : reports 1Q loss
AQ
02/12CEL-SCI CORPORATION : Reports First Quarter Fiscal 2018 Financial Results
BU
02/12CEL SCI : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULT..
AQ
02/12CEL SCI : to Present Tomorrow at 2018 BIO CEO & Investor Conference
BU
02/08CEL SCI : U.S. Patent Office Allows New CEL-SCI Patent For LEAPS Vaccine Platfor..
AQ
02/05CEL SCI : to Present at 2018 BIO CEO & Investor Conference
BU
More news
News from SeekingAlpha
2017CEL-SCI TO REVERSE SPLIT STOCK 1 : 25 June 15 
2017CEL-SCI submits FDA response for its Phase 3 head and neck cancer trial 
2017FDA places CEL-SCI's late-stage Multikine study in head and neck cancer on fu.. 
2017Cel-Sci reports Q2 results 
2017CEL-SCI nabs new European patent covering Multikine; shares rally 41% 
Chart CEL-SCI CORPORATION
Duration : Period :
CEL-SCI Corporation Technical Analysis Chart | US1508375086 | 4-Traders
Managers
NameTitle
Geert R. Kersten Chief Executive Officer, Treasurer & Director
Patricia B. Prichep Secretary & Senior Vice President-Operations
Eyal Talor Chief Scientific Officer
Peter R. Young Independent Director
Bruno Jean Marie Baillavoine Independent Director
Sector and Competitors
1st jan.Capitalization (M$)
CEL-SCI CORPORATION15.33%25
GILEAD SCIENCES12.63%105 375
VERTEX PHARMACEUTICALS5.36%39 931
REGENERON PHARMACEUTICALS-15.55%34 113
BIOVERATIV INC93.47%11 243
GENMAB16.62%10 344