Tuesday, July 21, 2020 1:16:13 PM
Summary:
21% of patients in the placebo arm had SAEs while only 9% of leronlimab patients had SAEs, so the relative risk of patients experiencing SAEs was cut in half (but not statistically significant p = 0.06).
In addition, leronlimab was able to cut the rate of SAEs by nearly 2/3, from 0.39 SAEs/patient in the placebo arm to only 0.14 SAEs/patient in the leronlimab arm. This suggests that the primary endpoint of clinical score on symptoms at day 14 will be a grand slam. The simple binomial effect of number of patients with SAEs (which was marginally non-signficant) is amplified by the disproportional increase in number of SAEs in the placebo arm. SAEs are things like hospitalization, need for ventilator, etc. Most of the SAEs, if they are going to happen at all, tend to happen early. But it takes several days for full CCR5 occupancy with leronlimab and a few more days to reverse the SAEs. The SAE conditions in placebo group are not likely to resolve by day 14, but most of the leronlimab SAE conditions are, which will further separate leronlimab from the placebo.
Very bullish. Shorts NEED to cover before closing bell because the risk of an insistent gap is too great.
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