Talon, the RS centers of excellence were taken into account in my timeline. Every center will have a cadre of educated motivated parents in their clinics. That will allow for more rapid recruitment than a typical study (i.e. PDD which affects a subset of PD, many older, does not have the same activist mentality). This is why 5 months might be achieved (though I think it will be longer, especially if there are 3 or more sites and academic IRBs are required). These 15 patients will not roll into the larger phase 2 (which is why it is a good thing that Anavex will give out free drug to them after the study). FDA changes will not significantly shorten the time it will take to prepare the larger study after the smaller one.
I suspect that some clinical scales will be used in the little study as an exploratory measure. Unlike AD where ADAS-Cog or CDR-SB are the gold standard measures of cognition, Rett studies each seem to use different ones. I expect they will want to use several in order to determine which will make the best primary and secondary endpoints for the larger phase 2.
We will see soon as they may PR the first enrollment and I believe they will need to post on clinicaltrials.gov
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