Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome, page-36

While I agree that this meeting taking place isn’t a guarantee of alignment with the FDA, I think there are strong signs that agreement is likely.

Firstly, this a Type C meeting; not a Type A meeting.

Type A meetings are for products with stalled development programs or for resolving disputes.

Type C meetings are reserved for issues that do not fit in these categories and can be used to consult on the use of a biomarker as a new surrogate endpoint that has never before been used.

https://www.raps.org/News-and-Artic...uidance-on-formal-meetings-adds-new-categorie

Sure, Neuren isn’t proposing a biomarker as a surrogate endpoint but it is designing a pivotal trial without precedent.

Secondly, the language used by JP in the announcement is confident and I doubt that he would be referring to completion of discussions and timetable for commencement of Phase 3 unless he was almost certain that formal agreement will be reached.

A Type C Meeting was considered by FDA as the best forum for completion of the remaining efficacy endpoints discussion.

we are… planning for mid-year commencement of the first ever Phase 3 trial for children with Phelan-McDermid syndrome.

I’m relaxed.