{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-037728","form_type":"8-K","ticker":"NVAX","cik":"0001000694","company_name":"NOVAVAX INC","filed_at":"2025-04-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.115264+00:00","generated_at":"2026-05-23T07:48:57.720914+00:00","sec_items":["7.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Novavax says COVID-19 vaccine BLA approvable; FDA requests additional clinical data as PMC","bullets":["Believes BLA is approvable based on FDA conversations as of PDUFA date April 1 and through April 23.","Received formal FDA information request for a post-marketing commitment (PMC) to generate additional clinical data.","Intends to engage expeditiously with FDA to address the PMC and move to approval as soon as possible."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-037728","json":"https://secwatch.observer/filing/0001104659-25-037728.json","markdown":"https://secwatch.observer/filing/0001104659-25-037728.md","text":"https://secwatch.observer/filing/0001104659-25-037728.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925037728/0001104659-25-037728-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1000694/000110465925037728/tm2512925d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T07:48:57.720914+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"}