CorMedix (CRMD) Receives Request for Additional Data for Neutrolin in the EU

June 14, 2012 4:07 PM EDT Send to a Friend
CorMedix Inc.(NYSE Amex: CRMD) announces the receipt of a request for additional information and data, including six month stability data on the third and final test batch from TUV-SUD (the Testing and Certification Group) and MEB-Netherlands (the Competent Authority) on the CE Mark application for Neutrolin® in the EU. Upon delivery of the requested information, the Company believes that Neutrolin® will enter a third and final round of review to finalize the CE Mark. CorMedix anticipates providing such additional information and data in late 3Q or early 4Q 2012. As a result, CorMedix now anticipates a final review and determination regarding its CE Mark application by the end of 4Q 2012.

CorMedix is currently in the final stages of completing its commercialization plan and is in discussions with several potential partners regarding the launch of Neutrolin® in Europe. Based on the status of such discussions CorMedix continues to target a commercial launch for 4Q 2012 / 1Q 2013.


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