Agamree: how long were the pivotal tox studies?

“Oral administration of vamorolone (0, 2, 10, or 50 mg/kg/day) for 39 weeks to dogs resulted in spermatocyte and spermatid degeneration in the testes and oligospermia and germ cell debris in the epididymis in males at the high dose and absence of corpora lutea in the ovaries in females at all doses.”

“Vamorolone was evaluated in oral repeated-dose toxicity studies for up to 6 months in mice and 9 months in dogs”

“Vamorolone was evaluated in oral repeated-dose toxicity studies for up to 6 months in mice and 9 months in dogs”