{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-22-037426","form_type":"8-K","ticker":"FENC","cik":"0001211583","company_name":"FENNEC PHARMACEUTICALS INC.","filed_at":"2022-03-24T23:59:59+00:00","discovered_at":"2026-05-14T18:04:05.612631+00:00","generated_at":"2026-06-26T18:06:55.821518+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Fennec resubmits NDA to FDA for PEDMARK to prevent pediatric ototoxicity","bullets":["Resubmitted New Drug Application (NDA) for PEDMARK (sodium thiosulfate anhydrous injection).","Indication: prevent platinum-induced ototoxicity in pediatric patients (1 month to <18 years) with localized solid tumors.","CEO Rosty Raykov cited close work with FDA during the review process."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-22-037426","json":"https://secwatch.observer/filing/0001104659-22-037426.json","markdown":"https://secwatch.observer/filing/0001104659-22-037426.md","text":"https://secwatch.observer/filing/0001104659-22-037426.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1211583/000110465922037426/0001104659-22-037426-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1211583/000110465922037426/tm2210369_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T18:06:55.821518+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"}