Tony, I think you may find that the reporting of the results will not go through the FDA. My understanding is that Acadia have already agreed with the FDA as to how the statistical findings from the results will be analysed. That is, Acadia will unpack the results themselves and analyse the data themselves. Once they know the results they (and Neuren) will release same to the market. Acadia will then work through the NDA process with the FDA in the coming months.
Given the above, I would now be at all surprised to see an announcement on the trial in November.
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