The CNPV is a new program and no one outside of the government knows how it works or how the decisions are made.
Anavex can give its application its best shot as will many other companies. The odds are against any one company. To say this is a test of management skills is like saying a roll of the dice is a test of the dice throwers skills.
All you say is true about the Anavex program. Predicting what a bureaucracy will do when faced with a new situation is a fools errand.