Humanigen Inc (HGENQ)

[cowtown jay]

It's confusing, LPF.

Dale gave the impression that we focused on SWOV because he thought the FDA was heading in that direction, as I recall.

Then the NIH finds that because we were not powered to detect a survival benefit, that that constituted a Key Limitation in our trial.

Then they state they find insufficient evidence to recommend lenz as an effective GM-CSF inhibitor, during the time we are still waiting for the FDA to approve our EUA.

However, now the NIH wants to modify our ACTIV5 trial. I wasn't able to see the ACTIV5 update until tonight, which still reflects a Phase II trial, but with 400 patients, and a primary outcome measure of "Time to ventilation or death in subjects with a baseline score of 5 or 6 [ Time Frame: Day 1 through Day 29 ]."

https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&cond=Covid19&cntry=US&draw=1&rank=2

I can think of another company that stuck with their mortality endpoint in a trial of 396 patients, and it didn't work out too well for them. And I am concerned that Dale thought we were under-powered, with 520 patients, to show a mortality benefit. Also, we had more improvement when used with a corticosteroid than we did with remdesivir, but it doesn't look like the ACTIV5 is using a corticosteroid. In addition, the trial will include patients suffering from, "Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO)." We did not do that in our internal trial. Our Hazard Ratio for mortality could be negatively impacted by this inclusion.

dlog may be right, and I just need to calm down. But I won't do that until we have regulatory approval from somewhere, and we can get this product into the market.