On a slightly different topic- i emailed Jon and asked him if he had any concerns regarding the CRL the FDA provided to Acadia. I was worried the FDA were shifting the goalposts and perhaps they could do the same with us even if we repeated the P2 results which we have been advised is all we need to do. His response is below. I think his comments can also be put into context with the diarrhea side effect. Given there is no treatment to for this condition i dont think diarrhea is a great concern.Hi XXXX, It’s a different division of FDA (Neurology versus Psychiatry) and an orphan drug in a serious condition affecting kids with no treatment options is a very different situation to the large and broad indication Acadia are chasing. So whilst I have great sympathy with Acadia about what has happened, I don’t think it implies anything relevant.
Regards, Jon
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