European Medicines Agency Grants CEL-SCI a Waiver of Strict Pediatric Requirements, Clearing the Path Towards Marketing Authorization for Multikine®
Cel-Sci Corporation (CVM)
NASDAQ:AMEX Investor Relations:
cel-sci.com/investor_relations.html
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Source: Business Wire
CEL-SCI has cleared a significant hurdle that mandates cancer drugs in Europe comply with strict requirements for pediatric usage and clinical evidence VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today announced that the European Medicines Agency (EMA) Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union (EU). According to the opinion letter:This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240131910101/en/Figure 1: The Phase 3 data showed that patients with pre-surgical responses from Multikine lived far longer than those without Multikine (Photo: Business Wire)“The Paediatric Committee, having assessed the waiver application in accordance with Article 13 of Regulation (EC) No 1901/2006 as amended, recommends as set out in the appended summary report:to grant a product-specific waiver for all subsets of t
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Sec Filings
- 4/23/24 - Form 3
- 4/23/24 - Form 4
- 4/23/24 - Form 4
- CVM's page on the SEC website