Roctavian: how long were the pivotal tox studies?

“In single-dose toxicology studies conducted in adult male :CD1 mice with study durations up to 6 months, the IV administration of ROCTAVIAN at dose levels of 6.53 × 1013 vg/kg and higher resulted in dose-dependent adverse histopathologic findings in the heart”

“Then, two GLP single-dose studies were conducted in normal CD1 mice with observation periods of up to 26 weeks, and with doses ranging from 6E12 to 2E14 vg/kg.”

“All in vivo studies were single dose and used the intravenous (IV) route of administration.”