u/Suitable-Increase-38

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?

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u/Suitable-Increase-38 — 8 days ago

FOMO kicking in now for many people. Let fuckig go

I'm surprised by how an earning call that showed a loss but not as much of a loss as was expected is generating so much hype. I'm not complaining, I've been in on CMPS for a while. I mean, I don't really care too much about earning right as they aren't actually selling a product yet, but I am happy to see the price movement

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u/Suitable-Increase-38 — 8 days ago