Hi Kerrybrad,
It appears the FDA rejected approval due to 2 points.
1) Proof of efficacy using a small, open-label, uncontrolled trial. The fact that the controlled C19 ARDS trial got nowhere near the efficacy of the open-label EAP would tend to support the FDA view.
2) The FDA had concerns surrounding the MOA and the manufacturing process of the cells. My take was they don't believe MSB truly knows precisely how the cells work.
If MSB don't know how they work, how can the biomarkers used to measure batch to batch potency be relied upon?
Hi Kerrybrad,It appears the FDA rejected approval due to 2...
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