Have to say the last minute nerves are are picking up.
I could easily see the FDA not approving due to the data - RSBQ isa questionable measure, and the CGI-I (which FDA asked to be included) results weren't spectacular. They sit right in the middle between 'No change' and 'Minimally improved'.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2880930/table/T2/
Is an expensive drug with side-effects worth approving if the improvement may be minimal?
That being said this is the only drug that's ever made it this far for Rett and the patients need an option. That might sway it.
FDA, page-50
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