Stealth BioTherapeutics Granted Pre-NDA Meeting For Elamipretide As A Treatment For Cardiomyopathy In Barth Syndrome
Share this article Share this article BOSTON, Jan. 5, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced its plan to meet with the FDA's Division of Cardiology and Nephrology (DCN) regarding its upcoming NDA submission for elamipretide for the treatment of cardiomyopathy in Barth syndrome. This Type B Pre-NDA meeting follows prior interactions in 2019 with the Division of Neurology Products (DNP...
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