All I am saying is that the FDA uses the term confirmatory data to mean a further trial - sometimes referred to as a phase 4 trial. It is used by the FDA if they need further evidence of safety of efficacy.
Safety is not the concern here, so I can only assume it is efficacy.
It is consistently used by the FDA since as long as I can remember.
If you choose to ignore this, that is your choice.
DEP always first, page-17
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