Another observation in terms of trial design - the trial accepts anyone over 18.
That to me is a risk in that we might expect different underlying clinical conditions in, say, an 18 year old to an 80 year old. We might see an effect in one and not the other. One of the golden rules of trial design is to define the trial group as tightly as possible to ensure homogeneity (tempered of course by the need for a broad label claim).
Also, as @Ratfink has pointed out, the FDA usually insists on 2 Phase 3 studies, so approval is potentially a long way off.
Another observation in terms of trial design - the trial accepts...
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