Genelux announces alignment with FDA of approval pathway for Olvi-Vec

Genelux (GNLX) Corporation announced that Genelux has concluded a productive Type D meeting with the U.S. Food and Drug Administration, FDA, for Olvi-Vec in the treatment of platinum resistant/refractory ovarian cancer, PRROC. Currently, Olvi-Vec is being evaluated in the OnPrime/GOG-3076 Phase 3 registrational trial in the United States, with the primary endpoint of progression free survival. The purpose of the FDA meeting was to discuss the FDA’s expectations with respect to the requirements necessary for the granting of traditional approval of Olvi-Vec.