Lupuzor phase 3 to start

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waterloo01
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Date Joined Oct 2013
Total Posts : 10
   Posted 1/22/2015 4:43 AM (GMT -6)   
The clinical study is titled "A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus". It is a pivotal study designed to demonstrate the safety and efficacy of IPP-201101 and as a last step prior to the filing of the drug for approval with the US Food & Drug Administration ("FDA") and the European Medicines Agency ("EMA").

http://www.immupharma.org/regulatory-news
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