Orlynvah: which risks did reviewers probe?

“Monkeys also exhibited positive Coombs test results that tended to increase with sulopenem etzadroxil dose and likely contributed to antibody mediation of minimal erythrocyte loss and compensatory erythropoiesis in monkeys.”

“The tissues with the highest AUC exposures to radioactivity over a period of 168 hours after dosing were in descending order: kidney, liver, lung, skin, pancreas, spleen, and blood.”

“The findings in juvenile rats occurred at lower sulopenem etzadroxil doses and exposures than the doses associated with renal findings in adult rats in the 1-month study, and the findings were poorly reversible or, in the case of tubular concretions, irreversible after a 2-week recovery period.”