{"schema_version":"secwatch.filing_event.v1","accession":"0001654954-21-007693","form_type":"8-K","ticker":"CVM","cik":"0000725363","company_name":"CEL SCI CORP","filed_at":"2021-07-07T23:59:59+00:00","discovered_at":"2026-05-14T18:04:20.621674+00:00","generated_at":"2026-06-30T07:03:33.877686+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"CEL-SCI Reports 14.1% 5-Year Survival Benefit in Phase 3 Multikine Trial; Plans FDA Submission","bullets":["Multikine showed a statistically significant 14.1% absolute improvement in 5-year overall survival in patients receiving surgery plus radiotherapy (n=380).","The successful treatment arm represents 40% of the study population, estimated at 155,000 newly diagnosed advanced head and neck cancer patients annually.","Analysis of the surgery plus radiation arm was pre-specified in the protocol and statistical analysis plan before unblinding, permitting FDA submission use.","Company intends to meet with FDA for pre-BLA meeting and file for approval of Multikine in this patient population.","No safety issues were identified; the survival benefit increased over time with a hazard ratio of 0.68 (p=0.0236)."],"urls":{"canonical":"https://secwatch.observer/filing/0001654954-21-007693","json":"https://secwatch.observer/filing/0001654954-21-007693.json","markdown":"https://secwatch.observer/filing/0001654954-21-007693.md","text":"https://secwatch.observer/filing/0001654954-21-007693.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/725363/000165495421007693/0001654954-21-007693-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/725363/000165495421007693/cvm_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-30T07:03:33.877686+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}