Humanigen Inc (fka HGENQ)

[cowtown jay]

Man, it feels good to see someone here (or anywhere, really) talk about the failed toci trials. But in fairness, they did meet a SWOV primary endpoint in one of those trials, showing a survival increase of 44%, ten percentage points below our lowest survival benefit of 54%. The FDA knew that, because they had our EUA application for a month at that time. They also know about our 1.9 Hazard Ratio, and still granted Roche an EUA with a survival benefit that only did half as well as lenz.

And I was impressed to see that fact recognized in the article. "The road to EUA was a rocky one, as the drug failed to meet the primary and secondary endpoints of a study when paired with Gilead’s remdesivir in March 2021. In two Phase III studies before that, one met the primary endpoint, while the other did not." The other failure was from a case controlled study.

I almost, literally, get sick about that.

The Health and Human Service's OIG really needs to take a look at these facts. The FDA's willful negligence is causing thousands of preventable deaths on a daily basis.