Can someone help me understand the regulatory pathway for CMPS?
As far as I understand it, normally a company would submit their NDA, the FDA would would officially accept it, which I think is called a filing decision. Then there would be a period of review usually followed by a 3rd party advisory board who would make recommendations to the FDA based on their own review, then the FDA would announce if they approve it or not. But from what I have read this is not the way things are going to go with CMPS because of the rolling submission and priority review.
Does anyone know if there will be a 3rd party advisory board similar to Lykos? If not what will the singal be when we are approaching an approval decision?