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.
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.
NEU Price at posting:
$14.06 Sentiment: Hold Disclosure: Held
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