Kisunla: how long were the pivotal tox studies?

“The dosing period was approximately 5 months.”

“In the pivotal (GLP) studies, mE8c was administered to 12- to 15-month-old PDAPP mice weekly for 6 weeks (0, 10, 30, or 100 mg/kg SC) or 5 months (0, 30, or 100 mg/kg SC).”

“Cynomolgus monkey: in the 6-week (GLP-compliant) IV toxicity study (with 3-month recovery), donanemab was administered by IV injection at doses of 0, 1, 10, and 100 mg/kg QW.”