Sunday, September 12, 2021 3:23:02 PM
You are correct about moderates in the Activ-5 trial but not about critical. With lenzilumab showing benefit in CRP < 150 which shows the start of severe illness those 6 and 7s on the ordinal scale will destroy the p value.
Looking at the full data I did notice that there were 4.7% less patients on High Flow Oxygen or NPPV in the leronlimab arm. Also there were 4.1% more patients with CRP < 150 in the placebo arm. So you have more placebo patients in worse condition and more with a lower CRP. Which could definitely skew results by looking at CRP < 150 as the basis of analysis. No wonder the FDA rejected the EUA.
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