{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-031099","form_type":"8-K","ticker":"NVAX","cik":"0001000694","company_name":"NOVAVAX INC","filed_at":"2025-04-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.114949+00:00","generated_at":"2026-05-23T23:05:02.258089+00:00","sec_items":["7.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Novavax says FDA missed PDUFA deadline for COVID-19 vaccine BLA; still awaiting decision","bullets":["FDA's April 1 PDUFA date passed; no official decision received as of April 2, 2025.","Novavax completed all FDA information requests and believes BLA is ready for approval.","Phase 3 data cited showing vaccine is safe and effective for COVID-19 prevention.","Company positions its vaccine as an attractive alternative to mRNA COVID-19 vaccines in U.S."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-031099","json":"https://secwatch.observer/filing/0001104659-25-031099.json","markdown":"https://secwatch.observer/filing/0001104659-25-031099.md","text":"https://secwatch.observer/filing/0001104659-25-031099.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925031099/0001104659-25-031099-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925031099/tm2511339d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T23:05:02.258089+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"}