CorMedix Inc. (CRMD) on Thursday announced 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 and MEB-Netherlands 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 third quarter or early fourth quarter of 2012.
As a result, CorMedix now expects a final review and determination regarding its CE Mark application by the end of 2012.
CorMedix said it is currently in the final stages of completing its commercialization plan and is in talks with several potential partners regarding the launch of Neutrolin in Europe.
Based on the status of such talks CorMedix continues to target a commercial launch for fourth quarter of 2012 or first quarter of 2013.
by RTT Staff Writer
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