Having completed an analysis of data from its terminated ORA-D-013-1 Phase 3 trial, Oramed is optimistic about prospects for ORMD-0801, particularly for certain subpopulations of patients with specific parameters that match those of study participants who responded well to oral insulin. ORMP has initiated discussions with the FDA and plans to launch a Phase 3 oral insulin trial in the U.S. under a differentiated protocol aligned with the positive data. Separately, a recent licensing agreement with Genomma Lab could provide attractive royalty revenue, if Genomma can commercialize an OTC hemorrhoids treatment & other products for which ORMP had acquired the rights.
