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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

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Rare but serious events encompass provocation or exacerbation of seizures in susceptible individuals and hypersensitivity reactions ranging from urticaria to anaphylaxis

112 There were no significant between-group differences on other measures of neuropsychological function, or measures of anxiety, depression, or loneliness

None of these episodes of drop in blood pressure led to death or long-term problems for the patients, however, and the blood pressure returned to baseline in these cases