When the initial meetings with the FDA were taking place there was relative calm in the United States.
This process has proceeded under a cloud of chaos and turbulence and sadly may continue that way for some time to come.
My personal timelines or expectations of progress went out the window after the Nov election and were further skewed after the proposed selection of Kennedy.
I am relieved that a meeting has been secured as this could easily have been thrown on the indefinite pile to be looked at ‘in the future’.
Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome, page-12
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