{"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","discovered_at":"2026-05-14T18:04:11.818553+00:00","generated_at":"2026-06-28T04:46:54.605771+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Fennec receives FDA Complete Response Letter for PEDMARK NDA citing manufacturing deficiencies","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-21-144897","json":"https://secwatch.observer/filing/0001104659-21-144897.json","markdown":"https://secwatch.observer/filing/0001104659-21-144897.md","text":"https://secwatch.observer/filing/0001104659-21-144897.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T04:46:54.605771+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"}