AnGes has applied Vical's technologies to the local delivery of a gene that encodes an angiogenic growth factor that promotes the growth of blood vessels. AnGes announced that it had reached agreement with the FDA regarding a Special Protocol Assessment for a Phase 3 clinical trial of its Collategene™ angiogenesis product and that the FDA has granted “Fast Track” designation to Collategene™ as a treatment for critical limb ischemia. AnGes is currently preparing for a global Phase 3 clinical trial of Collategene™ in patients with advanced PAD. AnGes believes having Japanese sites participate in the global Phase 3 trial represents the best potential pathway to approval in Japan, and has withdrawn its New Drug Application (NDA) previously submitted to the Japanese Ministry of Health, Labor and Welfare.