I don't have the greatest knowledge in this area, but my understanding is a small sample size (even though more difficult) would be to show proof of concept - or efficacy - which in my opion is already done in part, but a large ph2 or ph3 trial will still be needed before potentially becoming commercialised. Which is the outcome I would expect to see with Xanamen in 4-5 yrs.
So if I were on the board and putting a strategic plan together I would be pushing for a large trial straight away. Even if that means a CR is required.
Happy to be corrected on what the path to commercialisation is (excluding fast track, etc).
Cheers
IMO, etc
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