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A large number of mutations has been identified on pyruvate dehydrogenase gene and PDH DS results from mutations of E1 subunit for most of the patients [37,38]
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In a Complete Response Letter, the regulator stated that Aldeyra’s New Drug Application did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and informed the company that “at least one additional adequate and well-controlled study” would be required to demonstrate efficacy
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