secwatch.observer — SEC 8-K summary
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Issuer:     CEL SCI CORP (CVM)
CIK:        0000725363
Form:       8-K
Filed at:   2023-07-14T23:59:59+00:00
Accession:  0001654954-23-009179
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CEL-SCI reports positive FDA meeting for Multikine approval; Canada possible 2024
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/725363/000165495423009179/0001654954-23-009179-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/725363/000165495423009179/cvm_8k.htm
  HTML page:      https://secwatch.observer/filing/0001654954-23-009179

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer