other material
confidence high
sentiment positive
materiality 0.80
CEL-SCI reports positive FDA meeting for Multikine approval; Canada possible 2024
CEL SCI CORP
- FDA acknowledged need for improved head/neck cancer treatments; CEL-SCI preparing further development plan.
- Multikine showed 14.1% absolute OS benefit in lower-risk ITT subjects; 15.2% tumor response in 3 weeks.
- Health Canada advised NOCC application; commercialization in Canada could begin as early as 2024.
- Upcoming scientific advice meetings with EMA and MHRA in fall 2023.
- CEL-SCI plans to file NOCC application in Canada later this year/early next year.