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CorMedix Gets Positive Feedback From FDA For Neutrolin Clinical Trial Protocol

CorMedix Inc. (CRMD) announced that the U.S. Food and Drug Administration or FDA has provided positive feedback regarding a second pivotal clinical trial protocol. The new Phase 3 protocol is designed to assess the use of Neutrolin as a catheter lock solution in oncology patients who require total parenteral nutrition or TPN to support filing of a New Drug Application with the FDA. The comments provided by the FDA should enhance the quality of the proposed study.

Neutrolin has shown antimicrobial activity against many of the pathogens that result in catheter related bloodstream infections in the oncology community. Infections pose a significant risk for oncology patients, many of whom require the long-term use of central venous catheters.

CorMedix hopes that the use of Neutrolin in this susceptible population will help address a critical unmet medical need. Previously, the FDA reviewed the pivotal Phase 3 clinical trial protocol to evaluate the use of Neutrolin in hemodialysis patients, and preparations are underway to initiate the trial subject to identification of funding or strategic partnering.

Neutrolin received QIDP and Fast Track designations earlier this year.

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