@imback, Thanks, the "Least Burdensome Approach" link is for medical devices, but I agree we're certainly in a regulatory climate where the FDA is cooperating to expedite things.
I noticed this evening Humanigen's lenzilumab was chosen by NIAID for a "Big Effect Trial" to be done using it in combination with remdesivir. It was on my May 21 list where I expressed concern it might be slightly ahead of us in phase 3. Looks like NIAID liked some preliminary results.
Let's see if something similar might happen with rem-L.
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