Humanigen Inc (fka HGENQ)

[Knuckle Sandwich]

Jay, this was from the most recent filing. I wonder if this means we are closer to EUA than we think? Does expanding trial from 300 to 500 have more to do with BLA information?

Lenzilumab is currently in a phase 3, multi-center, double-blind, placebo-controlled registrational trial for hospitalized, hypoxic patients with COVID-19 pneumonia. Based on our discussions with the U.S. Food and Drug Administration (“FDA”), including a recent Type B meeting, we believe that the phase 3 trial could lead to a potential filing of an Emergency Use Authorization (“EUA”) application if data warrant such a filing. If the EUA were filed and granted, we could begin commercialization. We also intend to file a Biologics License Application (“BLA”) in 2021. Based on discussions with FDA, we understand that a BLA will require us to generate and present more clinical data than would be required to support an EUA.