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In October 2022, the regulator issued a CRL, requesting additional information and analysis related to the infusion device and drug product across several areas of the New Drug Application (NDA)

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In this study, SARS-CoV-2 mitochondriopathy in COVID-19 pneumonia exacerbates hypoxemia, we see that the SARS-CoV-2 virus inhibits the first step in mitochondrial energy production

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