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The first Complete Response Letter, in which the regulator cited manufacturing issues, came in 2017, and the FDA issued a second CRL in March 2022, flagging signals of AKI

FGF23 acts in opposition to GH by increasing phosphaturia via suppression of Na-Pi 2a and 2c expression in proximal tubules and decreasing renal calcitriol synthesis, whereas it shares its calcium-sparing effects by enhancing renal calcium reabsorption in the distal tubule [81]

However, other studies found increased CSF permeability and BBB disruption in a subset of patients infected with SARS-CoV-2 with elevated Q-albumin ratios that correlated with markers of inflammation 64

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