I think Jon / NEU are approaching their FDA discussions regarding their proposed PMS Ph3 PMS trial in a very strategic manner.
Jon / NEU knows that obtaining a favourable / reduced set of requirements for the safety protocol and a clear set of requirements and end points similar to their Ph2 trial, will set the ground work for all future FDA discussions regarding new potential 2591 indications - including those discussions that Acadia may have with the FDA regarding 2591 for Rhett and Fragile X syndromes.
Despite the disappointment in the delay, I suspect Jon is very busy and focused on delivering more long-term value for shareholders that will enable this important new drug to be brought to the market to help many people sooner.
I think Jon / NEU are approaching their FDA discussions...
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