secwatch.observer — SEC 8-K summary
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Issuer:     CorMedix Inc. (CRMD)
CIK:        0001410098
Form:       8-K
Filed at:   2023-04-26T23:59:59+00:00
Accession:  0001213900-23-032876
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CorMedix to resubmit DefenCath NDA by mid-May; CMS proposes NTAP up to $17,111
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- Company will resubmit NDA for DefenCath to FDA by mid-May 2023 following Type A meeting.
- CMS IPPS 2024 proposed rule includes NTAP of up to $17,111 per hospital stay for DefenCath, conditional on FDA approval before July 1, 2024.
- Resubmission uses existing CMO and new heparin API supplier; expects 6-month Class 2 review.
- Company plans to add a 3 mL single-dose vial to commercial presentation based on market needs.
- NTAP amount based on 75% of WAC price ($1,170 per 3 mL vial) and average 19.5 vials per stay.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1410098/000121390023032876/0001213900-23-032876-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1410098/000121390023032876/ea177512-8k_cormedix.htm
  HTML page:      https://secwatch.observer/filing/0001213900-23-032876

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