Fragile X study, page-3

Treagus talked about this a bit at the AGM: he pointed out the challenge of hitting the "sweet spot" with trial design in order to do what's required to keep the FDA happy. One of the aspects that got discussed was precisely this: that it's mistake to go in too hard too early.

One of the comments he made was that the FDA likes to see a "dose range" in its trials (which is why there were two dose levels in the Rett trial).

Remember that the primary aim of the Ph II trial was safety. Of course they wanted to show efficacy (and they did), and of course BT would have been the preferred outcome. but I think it's fair to say that Neuren seems to be following the steps that the FDA demands, and that short circuiting that process isn't really on the cards.