Replies to post #32729 on Humanigen Inc (fka HGENQ)

[PhrmaBro]

Don, post EUA, the the commercialization rollout will take time.

There are currently > 10,000 covid hospitalizations / week. While only a (significant) subset of those are Lenz candidates, it’s easy to see that drug supply will be limited for months. For this reason I believe a measly 200 Activ-5 patients could be enrolled during initial rollout. Also with the proper focus, Activ-5 should enroll 50 patients/week making this enrollment debate moot. All that said, it’s possible this issue is the reason for the few week EUA delay, and may be the reason for HGEN management’s confidence EUA may be granted any day.

Activ-5 trial data collection is ongoing, but it’s not realistic to think it’s compiled patient by patient. Instead “interim analysis” is performed at planned intervals. They could be waiting for interim analysis, but I’m pretty confident they aren’t waiting for activ-5 for EUA. If I have time I’ll try to figure out how many existing MAB treatment EUAs were granted from interim analysis data rather than full study completion. I know it’s happened.

I completely agree NIH/BARDA/FDA have a plan here.