If you aren't familiar with Avanex below is some useful information. They changed the primary endpoint from the CGI-I to the RSBQ during the trial and ultimately the development hasn't gone further (to date). Interestingly they also changed to include the Anxiety, Depression, and Mood Scale (ADAMS) scale as a secondary endpoint which wasn't there originally.
Btw: Not suggesting that NTI is moving the goal posts like Anavex did. It is simply to show how particular the FDA is with these things.
