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
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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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CVM
News
- CEL-SCI Co. (NYSE: CVM) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025Business Wire
- CEL-SCI files to sell 1M shares of common stock for holders [Seeking Alpha]Seeking Alpha
- FDA’s Oncologic Drugs Advisory Committee Decision on Checkpoint Inhibitors Substantiates Potential of CEL-SCI’s Multikine® to Address Major Treatment Gap for PD-L1 Negative Cancer PatientsBusiness Wire
- CEL-SCI Selects Ergomed as CRO as it Gears Up for Confirmatory FDA Registration Study of Multikine® in Head and Neck CancerBusiness Wire
CVM
Earnings
- 8/14/24 - Miss
CVM
Sec Filings
- 11/15/24 - Form 8-K
- 11/13/24 - Form 8-K
- 11/8/24 - Form EFFECT
- CVM's page on the SEC website