secwatch.observer — SEC 8-K summary
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Issuer:     CEL SCI CORP (CVM)
CIK:        0000725363
Form:       8-K
Filed at:   2023-04-19T23:59:59+00:00
Accession:  0001654954-23-004924
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CEL-SCI to pursue Health Canada's conditional approval pathway for Multikine in head & neck cancer
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- Health Canada advised CEL-SCI to request approval under Notice of Compliance with Conditions (NOC/c) policy for Multikine.
- Plans to file drug submission for earlier access in Canada while preparing U.S. BLA and pursuing other country approvals.
- Phase 3 IT-MATTERS study in head & neck cancer showed median OS improvement of 46.5 months for lower-risk patients.
- Five-year survival: 62.7% for Multikine vs 48.6% control; tumor shrinkage >30% in ~1 of 6 patients in 3 weeks.
- 5 patients had complete tumor disappearance in 3 weeks prior to surgery.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/725363/000165495423004924/0001654954-23-004924-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/725363/000165495423004924/cvm_8k.htm
  HTML page:      https://secwatch.observer/filing/0001654954-23-004924

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