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FDA accepts CorMedix, Inc pivotal phase 3 study protocol; announces strategic business collaboration with Wonik Corp

Thursday, 14 Aug 2014 04:45pm EDT 

CorMedix Inc:Announce that the U.S. Food and Drug Administration (FDA) has agreed with the design of its pivotal Phase III protocol for Neutrolin in Hemodialysis patients, and the company plans to submit the IND for Neutrolin within the next 30 days.Pivotal Phase 3 randomized controlled trial (RCT) for Neutrolin is for use in hemodialysis patients with a central venous catheter.Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe.In addition, CorMedix announces strategic business collaboration with Wonik Corporation, a South Korean corporation with a strong medical device franchise within the Korean healthcare market. 

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0.19 +8.26%
27 Nov 2015