Humanigen Inc (fka HGENQ)

[cowtown jay]

It became somewhat incongruous on July 8th to expect the FDA to authorize lenz, and thereby demonstrate for all the world to see, that there is a schism in our government's health service agencies regarding something so significant as the best life-saving therapeutic candidate to treat a virus that has caused a worldwide pandemic.

If it was up to me, I would probably stop providing lenz to the NIH for their Activ5 trial.

I would appeal the NIH's finding that there was insufficient evidence for them to specifically recommend lenz as a GM-CSF inhibitor, and that Humanigen was treated unjustly by a collective determination which included inferior GM-CSF inhibitors.

I would dispute the Key Limitations they cited. Our study was powered to meet the evolving endpoint the FDA was recommending. I think the HHS OIG should look into why there were differences in supportive care in our study sites, and whether those differences should have resulted in a decrease of our Hazard Ratio rating.

https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/table-of-contents/

https://www.covid19treatmentguidelines.nih.gov/tables/table-4b/

The FDA should not be deterred in making a decision to approve an EUA for lenz, just because the Otilimab and Mavrilimumab mAbs collectivley caused the NIH to determine there was insufficient evidence to render a GM-CSF group recommendation.