"A Cooperative Research and Development Agreement (CRADA) that Humanigen entered into with the Joint Program Executive Office for Chemical, Biological Radiological and Nuclear Defense (JPEO-CBRND), provides for, among other support, regulatory, statistical and manufacturing subject matter advice to anticipation of an application for an EUA and eventually a BLA submission. The activities under the CRADA are being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), working in collaboration with JPEO-CBRND. These activities include providing regulatory representatives who may participate in informal or formal meetings with the U.S. Food and Drug Administration (FDA) and providing comments on submission prior to submitting to FDA.

Humanigen intends to file for EUA in the first quarter of 2021 either following interim data at 75 percent or at study completion. The Phase 3 trial evaluating patients hospitalized with COVID-19 is enrolling at sites across the U.S. and Latin America. Current enrollment stands at 300 patients."

https://www.humanigen.com/press/Humanigen-Ann...h-COVID-19