---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-21-144897"
form_type: "8-K"
ticker: "FENC"
cik: "0001211583"
company_name: "FENNEC PHARMACEUTICALS INC."
filed_at: "2021-11-30T23:59:59+00:00"
generated_at: "2026-06-28T04:46:54.605771+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Fennec receives FDA Complete Response Letter for PEDMARK NDA citing manufacturing deficiencies

## Summary
- FDA issued CRL on Nov 29, 2021, after PDUFA date of Nov 27, citing manufacturing deficiencies for PEDMARK NDA.
- PEDMARK is intended to prevent cisplatin-induced ototoxicity in pediatric patients 1 month to <18 years with localized solid tumors.
- Company plans to request a Type A meeting with FDA to discuss deficiencies and path to resubmission.
- Fennec had approximately $24M in cash and cash equivalents as of Sept 30, 2021.
- No approved therapy currently exists for this condition; company is committed to addressing CRL issues.

## SEC filing metadata
- accession: 0001104659-21-144897
- form_type: 8-K
- ticker: FENC
- cik: 0001211583
- company_name: FENNEC PHARMACEUTICALS INC.
- filed_at: 2021-11-30T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1211583/000110465921144897/0001104659-21-144897-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1211583/000110465921144897/tm2134244d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-21-144897
- JSON: https://secwatch.observer/filing/0001104659-21-144897.json
- Plain text: https://secwatch.observer/filing/0001104659-21-144897.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.