Adstiladrin: how long were the pivotal tox studies?

“dose levels of 2.5 x 1011 vp/animal (1x1011 vg rAd-IFN/mL in 1 mg/mL Syn3), 1.25 x 1013 vp/animal (5x1011 vg rAd-IFN/mL in 1 mg/mL Syn3), Syn3 alone (1mg/mL), or placebo control on Days 1 and 91, followed by a two month observation period”

“on Days 1 and 91, followed by a two month observation period in a GLP toxicology study.”

“studies involving the intravesical (the intended clinical route of administration) and intravenous (IV) routes of administration in rats and cynomolgus monkeys have been conducted.”