It seems abundantly clear there is a statistically significant reduction in SAEs in the mild to moderate group. Assuming there is also a significant reduction in SAEs in the severe group there will be a corresponding reduction of death in the active arm. It’s important to highlight that SAEs in the severe group are more likely to translate into death so lowering the number of SAEs is tantamount to lowering the death rate. Based on this logic investors should be prepared for an FDA decision on approval, Breakthrough Therapy Designation (BTD), or a Special Protocol Assessment (SPA) leading to approval.

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