regulatory
confidence high
sentiment positive
materiality 0.75
CorMedix resubmits DefenCath NDA to FDA for hemodialysis catheter infection prevention
CorMedix Inc.
- NDA for DefenCath resubmitted to FDA as of May 15, 2023; agency acknowledged receipt for processing.
- CEO Joe Todisco said resubmission follows prior earnings call; company aims for potential approval in 2023.
- DefenCath is designed to reduce bloodstream infections in hemodialysis patients using central venous catheters.
- Resubmission addresses prior FDA feedback; no specific timeline for review decision provided.