{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-23-016996","form_type":"8-K","ticker":"CRMD","cik":"0001410098","company_name":"CorMedix Inc.","filed_at":"2023-03-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:44.810177+00:00","generated_at":"2026-06-18T12:56:13.843397+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"CorMedix updates DefenCath NDA resubmission pathways; CMO 1 completes corrective actions","bullets":["CMO 1 completed all corrective actions from FDA's June 2022 inspection; awaits FDA feedback on compliance status.","Heparin API supplier updated DMF; FDA recently approved a supplement referencing same DMF, potentially removing warning letter barrier.","Company plans to submit Type A meeting request by mid-March to seek FDA guidance on CMO 1 clearance and API 1 DMF use.","Pathway #1 (CMO 1 + API 1) could be Class 1 (60-day review); Pathway #2 (CMO 1 + API 2) data expected mid-April, Class 2 (6-month).","Pathway #3 (CMO 2 + API 2) data delayed to Q3 2023; remains backup strategy."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-23-016996","json":"https://secwatch.observer/filing/0001213900-23-016996.json","markdown":"https://secwatch.observer/filing/0001213900-23-016996.md","text":"https://secwatch.observer/filing/0001213900-23-016996.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1410098/000121390023016996/0001213900-23-016996-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1410098/000121390023016996/ea174602-8k_cormedix.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-18T12:56:13.843397+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"}