{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-22-045631","form_type":"8-K","ticker":"CRMD","cik":"0001410098","company_name":"CorMedix Inc.","filed_at":"2022-08-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:55.653676+00:00","generated_at":"2026-06-24T01:54:28.516258+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"CorMedix receives second Complete Response Letter from FDA for DefenCath NDA due to manufacturing deficiencies","bullets":["FDA issued second CRL stating DefenCath NDA cannot be approved until deficiencies at CMO and heparin supplier are resolved.","No other deficiencies cited; clinical and labeling review completed per the CRL.","CorMedix entered agreement with Alcami as alternative manufacturer; expects to file NDA supplement around end of Q1 2023.","CMS published conditional NTAP reimbursement, effective if FDA approval by July 1, 2023; duplicate NTAP application planned for October 2022.","Management remains confident of pathway to approval in calendar 2023, with both existing CMO remediation and Alcami transfer."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-22-045631","json":"https://secwatch.observer/filing/0001213900-22-045631.json","markdown":"https://secwatch.observer/filing/0001213900-22-045631.md","text":"https://secwatch.observer/filing/0001213900-22-045631.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1410098/000121390022045631/0001213900-22-045631-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1410098/000121390022045631/ea164023-8k_cormedix.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T01:54:28.516258+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"}