The results from the recent Phase 3 trials were excellent. However, nothing is ever a slam dunk with the FDA for NDAs for a multitude of reasons. And this is regardless of Orphan Drug designation, priority reviews, high unmet patient needs, or if there’s no other approved treatments for the indication etc etc etc.
The article in the link below is very recent. Whilst it was published just before the December Retts results it does appear to ask valid questions about the suitability and adequacy of the Acadia’s trial endpoints which could be a factor when Acadia submit the NDA and it is assessed by the applicable Advisory Committee (which assesses the NDA and makes recommendations to the FDA) and then subsequently the FDA.
Please don’t think that I’m downramping or have an agenda. Rather I’m just passing on info which may give cause to pause, some food for thought and to temper expectations of a NDA slum dunk, even though I understand that the FDA had agreed to the trial endpoints in the collaborative trial design phase.
I have only been a recent short term holder of NEU and was lucky to ride the spike up but exited today for the moment. Will consider re-entering and am keeping an open mind and close watch.
Would appreciate thoughts and comments on the article.
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