As I recall, the required P-value is .05 or less to show statistical significance. The Hazard Ratio has to be >1.0 (which would indicate the same efficacy as the Standard of Care drug).
During the 104 days that the FDA sat on our EUA, we were showing a Hazard Ratio of ~1.54, a 54% improvement over SOC. In the meantime, Roche submitted an EUA with a Hazard Ratio of 1.44, and had failed to meet the primary endpoint in that trial for about the 3rd time. But they got an EUA for toci, anyway.
The company subsequently provided the establishment of CRP levels as a biomarker. I think that was peer reviewed by Lancet. Humanigen went on to evaluate the LIVE-AIR patients segregated by CRP levels, and demonstrated Hazard Ratios that ranged from 3.0 - 3.4. In yet another lengthy peer review of that data, this one from Thorax, they determined our Hazard Ratio was "only" 2.54.
Toci was awarded an EUA with a Hazard Ratio of ~1.44 because they failed so many trials, that they had established a large database. We were declined an EUA decision, because I'm sure we followed the FDA's guidance in regards to trial size required, but the FDA decided after the fact that they wanted to see more data.
So, millions of people worldwide likely suffered preventable deaths from covid and covid-related indications, since we submitted our EUA application. None of the regulators have been charged with willful or criminal negligence or manslaughter. And we are poised to repeat the process, and allow even more preventable deaths from this new covid variant, which threatens to overwhelm our healthcare system by the end of the month.
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