unusual study design imho, escalation process more usually with healthy volunteer studies I’m sure it could be done faster without having to go through 5 escalation groups of 14 days each
is that the design fda wanted?
they should have established safety of various doses through their existing patient work rather than having to repeat in Nox-Covid
Why not use that information and just select and test a couple of doses in Covid. EG high and low?
will be interesting to see how a suppository drug goes for Covid
Protocol, page-2
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