secwatch.observer — SEC 8-K summary
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Issuer:     FENNEC PHARMACEUTICALS INC. (FENC)
CIK:        0001211583
Form:       8-K
Filed at:   2021-11-30T23:59:59+00:00
Accession:  0001104659-21-144897
Event type: regulatory
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1211583/000110465921144897/0001104659-21-144897-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1211583/000110465921144897/tm2134244d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-21-144897

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