Yes, the results of that Sept meeting will be very interesting.I had been wondering why Acadia hadn't initiated any further steps with NNZ-2591 in FragileX or Retts now they have the rights for NNZ-2591 for these. Given the obvious benefits of NNZ-2591 vs Trofinetide (and the failure to extend Nuplaiz) you'd think it would be a top priority for them.
Now I wonder if they are also waiting for this FDA decision. If Neuren succeed if getting FDA agreement for a simplified trial protocol this would presumably apply to Acadia also, which could then substantially reduce the cost and time to market for Fragile X and Retts for them also.
So if Neurens request is granted (and you'd think they have a strong case - esp if Angelman results are also positive) then maybe that will be trigger for Acadia accelerating NNZ-2591 for FragileX and Retts.
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Yes, the results of that Sept meeting will be very interesting....
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