---
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"
generated_at: "2026-06-24T01:54:28.516258+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# CorMedix receives second Complete Response Letter from FDA for DefenCath NDA due to manufacturing deficiencies

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-22-045631
- JSON: https://secwatch.observer/filing/0001213900-22-045631.json
- Plain text: https://secwatch.observer/filing/0001213900-22-045631.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.