Remember that this is the first P3 trial EVER and ANYWHERE for Phelan-McDermid syndrome.
Synchronicity regarding efficacy endpoints with the FDA is paramount for optimal rigour in the trial.
Much, much better to do this face to face in a Type C meeting so everything is crystal clear, transparent and explicitly outlined.
Then the Magnificent NNZ-2591 will just get on and do the business as we know it will.
Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome, page-15
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