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Steady_T

06/18/24 3:08 PM

#461679 RE: hnbadger1 #461677

It's good to have a definition of cohort and where things are with that trial.

I had a conversation with IR some time back and inquired about the paper and was indicated that the paper had been going back and forth with the reviewers. So this seems to suggest that most of those issues have been resolved. Next up is when the Journal decides to publish.

I think the earliest I figured out that the MAA could be submitted was late July. So the question becomes, was the LOI submitted later than the centralized approval decision, or is preparation of the MAA taking longer than the 7 months. I guess they could also be waiting on the OLE data to include into the MAA.

Interesting that he said no meetings with the FDA. That also means they have all they need to start the next Rett trials. Getting the Rett and PD trials underway will be a good thing.