All of Neuren's current Phase 2 and post-Phase 2 candidates will...

All of Neuren's current Phase 2 and post-Phase 2 candidates will be eligible for priority FDA review (i.e 6 months) so there is no use for a PRV, which can only shorten review time for drugs facing standard FDA review.

Any PRV NEU receives on any approval of its current candidates will be owned solely by NEU. There is no provision for sharing with Acadia in the JV and Licence contract of last year. However, this amended contract does retain NEU's right to a third of the value of the PRV awarded to Acadia on the approval of trofinetide in Rett syndrome.

It has already been stated in recent NEU presentations that PHS is also eligible for Rare Pediatric Disease Designation so I expect it will receive this designation as well. However, only the first indication approved will receive one as only one PRV can be awarded per drug compound.