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With the current absence of technologies to rectify the actual mutations that underlie mitochondrial diseases, medical science can only address the resulting oxidative stress as a potential therapeutic option

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No there is no registered clinical trial of the GLOW combination

We considered a 10-day, 15-day, and 30-day Suggestion of Error period and we believe the 10-calendar-day period as set forth in 427.503(c) is sufficient after considering the volume of the data to be provided to manufacturers, the narrow scope of items that may be identified as a Suggestion of Error, and the operational time necessary for CMS to provide a Rebate Report within 6 months of the end of the applicable calendar quarter as required under section 1847A(i)(1)(A) of the Act