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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) and in 2019 and 2020 with the Division of Rare Disease and Medical Genetics (DRDMG) during which the Agency encouraged the Company to generate additional clinical data to support its Barth NDA submission, including by implementing a withdrawal protocol for the patients remaining on open-label extension. More recently, the Company met with DCN to discuss an NDA submission for the treatment of