"I wonder about 'degree' in this FDA feedback. They are now asking for a change, but is it a change to an agreed standard already submitted, is it an additional standard or protocol, is it something NEU missed (I doubt that with this team's experience).
Many questions."
I fully agree gingerclam, there are many questions and it would be good to see management address them for some much needed clarity.
Ann: Neuren receives feedback on IND for Phelan-McDermid syndrome, page-6
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