I could be argued that it would make most sense, if NNZ-2591 has successful results in all 4 current indications, for a well-resourced pharma to run concurrent Phase 3 trials. But from a risk-managing perspective, that might not be an attractive option for them.
Also, outside of those 4 indications, where does Acadia stand with NNZ-2591 in Rett and Fragile-X? Phase 2 or 3 trials are yet to be held and so are quite some years away from any FDA approval. Why would Acadia bother if, say, NNZ-2591 in PMS was approved in a few years’ time, setting off the ticking of the IRA clock on Acadia's in-licensed NNZ-2591 Rett and Fragile-X assets?
What does make sense to me is for Neuren to continue to proceed full steam ahead on Phase 3 in PMS as that just continues to add value. I think the big decision-making point wouldn’t come until the time of any NDA submission and, in the meantime, the IRA law might have been amended and/or Neuren might have already been acquired and it’s someone else’s decision to make!
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