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December 23, 2013
09:53 EDTCRMDCorMedix receives minutes from Neutrolin pre-IND meeting with FDA
CorMedix announced receipt of the official minutes from the November 14 Pre-IND meeting with the U.S. Food and Drug Administration. The minutes confirmed the guidance received from the FDA concerning the development of Neutrolin. CorMedix intends to work with the FDA to finalize a clinical protocol and file an IND to support activities required to commercialize Neutrolin in the U.S. "Commercializing Neutrolin in the U.S. is an important long-term goal for CorMedix, and is one that we plan to pursue in tandem with several, more immediate, key objectives," said Randy Milby, CorMedix CEO. "We recently began shipping Neutrolin to our first hemodialysis customers in Germany. As we enter 2014, we will be keenly focused on expansion into other targeted EU countries as well as non-European markets that recognize the CE Mark."
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