The UK’s Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI a Pediatric Waiver, Bringing Multikine® One Step Closer to Future Marketing Clearance
Cel-Sci Corporation (CVM)
NASDAQ:AMEX Investor Relations:
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Source: Business Wire
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported it has received a decision letter from the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)* a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be required to evaluate Multikine in a pediatric population as part of license and marketing clearance review in the UK.“While we prepare to commence our confirmatory FDA Registration Study of Multikine here in the U.S., and elsewhere, we are very pleased to receive continued positive responses from the UK’s healthcare regulatory agency. This pediatric waiver accelerates our path to marketing approval in the UK,” stated CEL-SCI CEO Geert Kersten.About CEL-SCI CorporationCEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possibl
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- CEL-SCI's Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation [Yahoo! Finance]Yahoo! Finance
- CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and RadiationBusiness Wire
- CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 CongressBusiness Wire
- CVM: Start Your Engines – FDA Green Lights Confirmatory Registration Study [Yahoo! Finance]Yahoo! Finance
- CEL-SCI Corporation Reports Third Quarter Fiscal 2024 Financial ResultsBusiness Wire
CVM
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- 8/14/24 - Miss
CVM
Sec Filings
- 9/17/24 - Form 8-K
- 8/30/24 - Form S-8
- 8/14/24 - Form 10-Q
- CVM's page on the SEC website