If there is a second way that management has shot us in the foot, other than by using boilerplate language to explain our Denial, then, in my opinion, it is the way they announced our trial results, which is headlined with a Hazard Ratio of 1.54 and a p value of just 0.0403, against our primary endpoint of IMV/death.
Granted, the trial doctors noted a correlation of CRP levels to our results, and announced those results on patients as you mention with CRP < 150 mg/L, and < 85 years old.
Slide 10
But even more of a game changer is what Durrant has been presenting at these various Breakthrough meetings, in terms of the, "...utilization of CRP as a biomarker (which) may offer an effective way to optimize lenzilumab treatment in hospitalized COVID-19 patients...Exploratory analysis of LIVE-AIR results in patients with CRP<150 mg/L and aged <85 years of age...show lenzilumab improved the likelihood of survival without ventilation by more than 3-fold (OR 3.04; 95% CI: 1.68-5.51, nominal p=0.0003) compared with placebo... and mortality was improved by more than 2-fold (OR: 2.22; 95%CI: 1.07-4.67, p=0.034). I think these are the results the FDA will be reviewing with management at next months meeting.
A mere 54% improvement should have awarded us an EUA, since toci subsequently got an EUA with a 44% improvement. So certainly, a 154% improvement should have caused the FDA to approve us. But it hasn't. Now, with a demonstrated ability to show a 2-fold improvement in mortality, the FDA has to act.
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