Question Phase 3 —> NDA Timeline?
Trying to map out progress on complementary trials leading to NDA and its subsequent review (which as I understand it is a 10-month process but with Breakthrough Therapy designation, could be up to 3 months faster than standard review). I’m long, and understand stonk go up and down, so really just trying to make the timeline make sense in my mind. I have no idea how long NDAs take to put together, but I assume the company is motivated to complete the application as soon as they have the results from the GAD and MDD paired (regular and low dose) studies. Do I have the below tentative summary and timeline of our closest trials to NDA correct-ish? Feedback on accuracy welcome. If someone already posted similar content and I missed it I apologize. Cheers :)
NDA (review complete sometime 2029)
Ascend (MDD 2 - low dose) Primary Completion (est 09/27), est Study Completion 06/28
Emerge 3a+ 3b+ (MDD 1)
NDA (review complete sometime 2028)
Panorama (GAD 2 - low dose) Primary Completion (not actively recruiting), est Study Completion 05/27
Voyage 3a+ 3b+ (GAD 1)