You might want to keep an eye on this. NAVB has a few reasons to be considered:
1. CRL on manufacturing only means almost "certain" FDA approval on resubmission ( but never say never )
2. almost no competition
3. CH partnership, huge backup on marketing, sales force, possibility for buyout
4. they have pipelines ( dementia, Alzheimer )
PDUFA date is April 30. A lots of time to get in.