{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-043889","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-12-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.474963+00:00","generated_at":"2026-05-16T15:40:53.493196+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"PDS Biotech schedules FDA Type C meeting to discuss accelerated approval for PDS0101 in HNSCC","bullets":["FDA accepted Type C meeting request; meeting scheduled for December 2025.","Agenda: proposed amendment to Phase 3 VERSATILE-003 for accelerated approval of PDS0101.","Amendment would change PFS to surrogate primary endpoint; mOS remains for full approval.","Based on positive VERSATILE-002 data showing mOS and durable PFS in CPS≥1 patients.","Company expects FDA meeting minutes in January 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-043889","json":"https://secwatch.observer/filing/0001140361-25-043889.json","markdown":"https://secwatch.observer/filing/0001140361-25-043889.md","text":"https://secwatch.observer/filing/0001140361-25-043889.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125043889/0001140361-25-043889-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125043889/ef20060301_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T15:40:53.493196+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"}