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January 11, 2013
16:08 EDTCRMDCorMedix files to sell 3.78M shares of common stock for holders
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October 27, 2014
08:54 EDTCRMDCorMedix receives approval from FDA to initiate Neutrolin clinical trial
CorMedix announced that the FDA has reviewed its Investigational New Drug application, or IND, for Neutrolin which was submitted September 24, and determined that the IND is not subject to a clinical hold, and that a pivotal clinical study can be initiated in the United States. CorMedix is a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. The IND includes a pivotal Phase 3 protocol for Neutrolin in hemodialysis patients with a central venous catheter. The Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program. CorMedix is currently developing an additional Phase 3 protocol to support the use of Neutrolin to prevent catheter related infections for oncology patients receiving total parenteral nutrition.

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