I dont see this pushing anything out.
They've always said midyear. They are already working on manufacturing and sites.
I guess enrolments might need to start veery soon.
But the type C meeting isn't going to change the trial format or dosages.
It's just setting up what the final outcome would need to be to be considered a pass.
And let's fact it, NEU know what end points are critical and which ones aren't.
They simply need to convince the FDA that they are right.
Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome, page-18
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