secwatch.observer — SEC 8-K summary
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Issuer:     CorMedix Inc. (CRMD)
CIK:        0001410098
Form:       8-K
Filed at:   2022-05-12T23:59:59+00:00
Accession:  0001213900-22-025946
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CorMedix: Q1 net loss $7.0M; FDA accepts DefenCath NDA resubmission with 6-mo review
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- Net loss $7.0M ($0.18/shr) vs $7.2M ($0.20/shr) in Q1 2021; operating expenses down 3%.
- FDA accepted DefenCath NDA resubmission as complete Class 2 response with 6-month review; inspection planned.
- New CEO Joe Todisco officially started May 10; CCO Tom Nusbickel departed by mutual agreement.
- Donna Ucci (SVP Global Quality) and Frank Raffaele (VP Supply Chain) hired; Liz Hurlburt promoted.
- Winding down European ops, discontinuing Neutrolin distribution to focus on US DefenCath launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1410098/000121390022025946/0001213900-22-025946-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1410098/000121390022025946/ea159840-8k_cormedix.htm
  HTML page:      https://secwatch.observer/filing/0001213900-22-025946

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