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Posted On: 07/05/2020 10:34:21 AM
Post# of 155038
Re: Borel Fields #41062
The numbers for CD12 will be in that range. I would not worry too much of the exact number today. We know Leronlimab was very effective in severe patients, calms the cytokines in 3 days. My read is that NP is confident of success in this trial results.
The CD10 trial was a bit more complicated. Mild to moderate has many more metrics to measure and compare to define success. Larger pool of patients could become important. They achieved 87 (?) patients in this trial which exceeded their 75 target. So once they unblind and see how these results initially look by mid July, and if good, they probably will ask FDA for interim review of CD12 immediately. They can then complete the analysis of the two trials and submit both to the FDA by end of July.
Pure speculation on my part but seems feasible.
The CD10 trial was a bit more complicated. Mild to moderate has many more metrics to measure and compare to define success. Larger pool of patients could become important. They achieved 87 (?) patients in this trial which exceeded their 75 target. So once they unblind and see how these results initially look by mid July, and if good, they probably will ask FDA for interim review of CD12 immediately. They can then complete the analysis of the two trials and submit both to the FDA by end of July.
Pure speculation on my part but seems feasible.
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