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Stock impact report

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: cel-sci.com/investor_relations.html
Company Research 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 Show less Read more
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