Approval can't be arbitrary? We have Hazard Ratios that ranged from 2.5 - 3.4 from our LIVE-AIR trial. Nothing nebulous about the superior results lenz showed in treating covid patients. But the FDA still declined to grant our EUA application. That's what discretionary authority for the FDA allows to happen.
As far as CMML, I think the data I linked in my previous post indicated that current Standard of Care yields a Complete Response rate ranging from 16-21%. I also think that the interim analysis of the PREACH-M study showed a Complete Response rate of 73%. The P-value was 0.02. This reflects my understanding of the data I linked earlier.
I think that level of improvement, complete with establishing biomarkers where there were none, justifies Dr. Thomas' excitement, as well as approval and regulatory incentives, including a PRV, from the Australian regulators.
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