secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2025-12-02T23:59:59+00:00
Accession:  0001140361-25-043889
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PDS Biotech schedules FDA Type C meeting to discuss accelerated approval for PDS0101 in HNSCC
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125043889/0001140361-25-043889-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036125043889/ef20060301_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-043889

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer