Questions I have based on the pre-ind and written responses received
IPIX: In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis.
1) what was the FDA recommendation
2) is IPIX in agreement with FDA's recommendation
These are 2 very strong pieces of information left out of IPIX's PR that would have given investors the insight as to when human trials will begin