Humanigen Inc (fka HGENQ)

[PhrmaBro]

Don we agree on much more than we don’t.

The large “recovery” was successful and met its primary endpoint and showed mortality benefit. Toci is only EUA for late stage and with steroids. Why with steroids, because that was the only circumstance where patient benefit was observed. Toci was also tested in other trials and failed to meet the primary endpoint.

There is plenty of antidotal evidence suggesting Lenz could get EUA with just their P3 results. Most straightforward, HGEN was allowed by the FDA to apply for EUA with just the P3 data.

For the record, I don’t buy any of the FDA conspiracy theories - regulatory capture, etc. I also don’t believe that vaccines being prioritized is the cause for delay. I suppose more data from Activ-5 is a possible reason for delay, but I don’t hear much about what I believe is the most likely reason. I think most likely the delay is due to an item in the CMC section of the EUA application which needs to be addressed.