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news.Diamyd Medical has filed an investigational new drug application with FDA for a pivotal US Phase III clinical trial with the Diamyd therapeutic vaccine in recent onset type I diabetes patients.
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Similar applications for a parallel European Phase III trial are planned to be submitted to European regulatory agencies. Diamyd Medical anticipates that two successful Phase III studies, each comprising 300 recent onset type I diabetes patients, may lead to market approval.
Elisabeth Lindner, president and CEO of Diamyd Medical, said: “The filing of the Diamyd investigational new drug application (IND) and a receipt of approval thereafter are prerequisites for conducting confirmatory studies in larger patient populations in the US and important steps towards making the Diamyd-vaccine available to the patients.”