Kebilidi: how long were the pivotal tox studies?

“There were no significant adverse findings noted in a 6-month toxicology study in rats administered dose levels ranging from 7.5x108 – 7.5x109 vg/animal.”

“Two single-dose studies were conducted to assess toxicity at 30-days and 6 months.”

“In the 6-month study a single eladocagene exuparvovec administration via bilateral IPI at doses up to 7.5×109 vg was generally well tolerated with no obvious signs of toxicity.”