The Company recently reported on its successful interaction with the U.S. Food and Drug Administration (FDA) in January 2024 regarding the potential to initiate a single registrational study in patients with hypoglycemia due to tumor HI. The Company will continue to evaluate the feasibility of a development program in this indication, with the possibility of including both ICTH and NICTH patients. The inclusion of NICTH patients in a potential addressable market for RZ358 in tumor HI would more than double the population.
So only 1 trial needed . Probably fairly small ( max 100 patients ) ...currently 1500 each yr with ICTH and another 2,000 with NICTH ( I think ) ...in the US High unmet need