I agree with Baldwin's comments. The FDA could well have stated we only need to replicate P2 when NEU/Acadia was designing the P3 trial but when push comes to shove for the FDA to vote on the NDA you dont know what will happen. In saying that it will come down to the results and also the fact this is treating a condition which currently has nothing so the advocacy groups would push hard for approval in my opinion.
Not long to go now.
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