As is customary, the Company is seeking Phase 3 scientific guidance from the EMA regarding the Brilacidin OM program. In December, Innovation Pharmaceuticals completed an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA), during which an acceptable Phase 3 development pathway was agreed upon to advance Brilacidin.
For the Phase 3 program, the Company anticipates international clinical trial enrollment, with participating sites located in the U.S. and in Europe. EMA advice is integral to this plan by helping to ensure that the program meets European standards.
International phase 3 in US and EU!! Woooo