Adding to the above...DAYBUEThe costs will be covered by US...

Adding to the above...

DAYBUE
The costs will be covered by US Medicaid, but due to the cost, each person needs to be individually authorised (hence the size of the Acadia team). 4,500 girls have already been registered. Most of the registrations should be completed by the end of the third quarter. Accordingly, JP said that little insight will be gained from the initial quarterly data (and revenue).

ROW
The shortlist includes prospects that will be able to supply to ROW, and others that will be able to supply regionally.

NNZ-2591
Given the improved NEU balance sheet, the delay from moving to P2 results to P3 trial should be minimal (and certainly not a repeat of what occurred for Trofinetide). Discussions will be opened without delay with both US FDA and EU EMA on the required design of the P3 trial.

The P1 (mouse model) results for NNZ-2566 provided a good degree of confidence that the P2 results would be positive. The P1 results for NNZ-2591 provided a similar degree of confidence going into the P2 trial.

Homework for those with the skillset: Are the NNZ-2591 P1 results stronger than those for NNZ-2566?

NEU has learnt an enormous amount over the past decade through the FDA process. The approval of Trofinetide was the first time the FDA approved a drug on the basis of a qualitative evaluation by medical practitioners. It paves the way for a similar P3 evaluation model for NNZ-2591.

Fragile X
It is not likely that anything will happen with Trofinetide and Fragile X. Long term investors will recall that the Fragile X results were marginal (at best), which was one of the reasons for the shift in focus to Rhetts Syndrome.

Revenue from Trofinetide for Fragile X will be incremental, but insignificant when compared to NNZ-2591. The impression I got from JP was that Fragile X revenue (if Trofinetide successfully completed trials) would be somewhat of a rounding error.

AGM
Following the meeting, JP was backed up against the wall and peppered with questions (which he seemed more than happy to answer). I advised him to ensure that he didn't schedule any back-to-back meetings on AGM day. I'm sure that when the room is populated with just SHs, he'll have trouble making it to any other appointments.

An excellent opportunity to hear from JP, particularly after the formal presentation.