Just a comment on your point 2) regarding SOL-R without addressing the rest of the post.
1. The trial design is not finalized IIRC they still need a type C meeting. 2. This IS a re-dose trial, which is kind of a big deal and the primary reason for the trial IMO. You could consider non-inferiority as a co-primary reason. Note that the Axpaxli and comparator arms get redosed after 6 months.
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