Is it too early to raise the question once more of what, if anything Breakthrough Therapy designation would mean for the company?
Last year about this time, and following the exciting success of Retts in phase two, Neuren had requested BT from the FDA which was denied (As most requests are). This year we are potentially in the same position - have NEU submitted an application for BT for Fragile X? I believe they have to, as once again they can prove efficacy of Trofinetide in an area of unmet need. Again, what could let us down is the small size of the trial. In our favour is those compelling ABC scores.
Dare I mention the words...
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