CorMedix: FDA Issues Feedback On Request Regarding DefenCath - Quick Facts

(RTTNews) - CorMedix (CRMD) said the FDA has provided feedback to the company's request to discuss development plans for additional indications for DefenCath. The company said FDA has provided supportive feedback regarding plans to pursue an expanded indication in adult Total Parenteral Nutrition patients. CorMedix plans to submit a complete clinical protocol to FDA in the third quarter with a goal of gaining further alignment and initiating the program by the end of 2024.

Also, the FDA confirmed its requirement that the company conduct a study in pediatric hemodialysis patients under the Pediatric Research Equity Act.

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