{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-23-032876","form_type":"8-K","ticker":"CRMD","cik":"0001410098","company_name":"CorMedix Inc.","filed_at":"2023-04-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.753847+00:00","generated_at":"2026-06-16T12:22:36.069728+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"CorMedix to resubmit DefenCath NDA by mid-May; CMS proposes NTAP up to $17,111","bullets":["Company will resubmit NDA for DefenCath to FDA by mid-May 2023 following Type A meeting.","CMS IPPS 2024 proposed rule includes NTAP of up to $17,111 per hospital stay for DefenCath, conditional on FDA approval before July 1, 2024.","Resubmission uses existing CMO and new heparin API supplier; expects 6-month Class 2 review.","Company plans to add a 3 mL single-dose vial to commercial presentation based on market needs.","NTAP amount based on 75% of WAC price ($1,170 per 3 mL vial) and average 19.5 vials per stay."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-23-032876","json":"https://secwatch.observer/filing/0001213900-23-032876.json","markdown":"https://secwatch.observer/filing/0001213900-23-032876.md","text":"https://secwatch.observer/filing/0001213900-23-032876.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1410098/000121390023032876/0001213900-23-032876-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1410098/000121390023032876/ea177512-8k_cormedix.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T12:22:36.069728+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"}