{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-23-050240","form_type":"8-K","ticker":"CRMD","cik":"0001410098","company_name":"CorMedix Inc.","filed_at":"2023-06-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.754495+00:00","generated_at":"2026-06-13T19:53:24.787700+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"CorMedix announces FDA acceptance of DefenCath NDA resubmission; PDUFA date Nov 15, 2023","bullets":["FDA accepted DefenCath NDA resubmission as a complete Class 2 response with six-month review.","PDUFA target action date set for November 15, 2023.","DefenCath is a catheter lock solution to reduce bloodstream infections in hemodialysis patients.","CEO Joe Todisco highlighted preparations for potential commercial launch."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-23-050240","json":"https://secwatch.observer/filing/0001213900-23-050240.json","markdown":"https://secwatch.observer/filing/0001213900-23-050240.md","text":"https://secwatch.observer/filing/0001213900-23-050240.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1410098/000121390023050240/0001213900-23-050240-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1410098/000121390023050240/ea180659-8k_cormedix.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T19:53:24.787700+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"}