FDA agrees Animal Rule pathway and PRV eligibility

Responses significantly de-risk Galidesivir regulatory pathway – Island is now the first Australian company with an opportunity to advance drug approval under the FDA’s Animal Rule • FDA confirms the Animal Rule pathway is appropriate for developing countermeasures against Marburg • FDA advises Galidesivir would qualify for a Priority Review Voucher (PRV) on approval – PRV’s command prices up to ~