secwatch.observer — SEC 8-K summary
======================================

Issuer:     CorMedix Inc. (CRMD)
CIK:        0001410098
Form:       8-K
Filed at:   2022-08-09T23:59:59+00:00
Accession:  0001213900-22-045631
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1410098/000121390022045631/0001213900-22-045631-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1410098/000121390022045631/ea164023-8k_cormedix.htm
  HTML page:      https://secwatch.observer/filing/0001213900-22-045631

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer