CorMedix (CRMD) announced that the FDA has responded to their request to discuss development plans for additional indications of DefenCath. The agency provided encouraging feedback on pursuing an expanded indication for adult Total Parenteral Nutrition patients. CorMedix intends to submit a comprehensive clinical protocol to the FDA in the third quarter, aiming to reach further consensus and commence the program by late 2024.
Additionally, the FDA reaffirmed its mandate for the company to conduct a study involving pediatric hemodialysis patients, as stipulated under the Pediatric Research Equity Act.
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