Humanigen Inc (HGENQ)

[cowtown jay]

I'm hoping, perhaps unrealistically, that we DON'T get news of an EUA application, and we skip right to the part of an EUA approval.

Our guys announced topline Phase III results, which required data through day 60 after treatment, on day 60. We know from their own comments that they have been working with the FDA throughout this process. We know, with the BARDA and CRADA agreements, we have the support of the US government through the Dept of Defense. We know that foreign entities and governments, where this disease has maxed out medical resources, that they have approached Humanigen about getting this product as soon as possible.

Monday will mark 4 weeks since topline data was released. So the question is, how prepared was management for the submission of the EUA application at that time? Was it just a matter, as it was for the topline data, to incorporate information from the last days of the trial, to submit the application?

I know what my medical manufacturing experience has been. I know what it's like to walk throughout the plant with the FDA inspector, answering his questions about whether he should validate the production of the breast implants we were manufacturing (he did). But what the Humanigen team is doing is broader than being directed solely to technical questions about the production of our manufactured antibody. I wish I had a better basis for understanding the task before them, and knew what was feasible, and what was not.