The other piece of news (for me) was which section of the FDA's Neuroscience Office is handling the various INDs.
Neuren hopes to receive clearance from the FDA after 30-day reviews of each submission. All three programs are supervised by the FDA Office of Neuroscience, with Phelan-McDermid and Pitt Hopkins reviewed by the Division of Neurology 1 and Angelman reviewed by the Division of Psychiatry.
I recall that Fragile X was under the Div of Psychiatry. There was also some speculation on the Forum here about a preferred Division. I'm not sure if there was anything in that, whether it was to do with treatment under the leadership of the various Divisions, or the speed and thoroughness with which they worked...but it is any interesting point as to why the NNZ2591 suite didn't all 'fit' under, say, Division of Neurology 1.
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