{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-039656","form_type":"8-K","ticker":"PDSB","cik":"0001472091","company_name":"PDS Biotechnology Corp","filed_at":"2025-10-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.474100+00:00","generated_at":"2026-05-17T01:37:36.927054+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"PDS Biotech requests FDA meeting to discuss expedited approval for PDS0101 in HPV16+ HNSCC","bullets":["Final VERSATILE-002 data: median PFS 6.3 months, median OS 39.3 months in recurrent/metastatic HPV16+ HNSCC.","Proposes amending Phase 3 VERSATILE-003 trial to add PFS as earlier primary endpoint for potential accelerated approval.","VERSATILE-003 temporarily paused during FDA review; currently enrolled patients continue treatment.","FDA meeting requested to expedite regulatory pathway based on strong survival results."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-039656","json":"https://secwatch.observer/filing/0001140361-25-039656.json","markdown":"https://secwatch.observer/filing/0001140361-25-039656.md","text":"https://secwatch.observer/filing/0001140361-25-039656.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125039656/0001140361-25-039656-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1472091/000114036125039656/ef20057871_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T01:37:36.927054+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"}