For those who feel PVCT has a solid story and track record it will be a mute point, right...PVCT will write a flawless application and the FDA will have to succumb to the will of management in 45 days, right...LOL
LOL...yea, FDA can say "the company has not provided sufficient evidence to support....." and have provided feedback with no guidance...hence the point that PVCT would have to come back shooting in the dark again.
I think the protracted process you read about here is from companies trying to re-submit without clear feedback from the FDA. In an iterative process two sides are working toward the center, with shared feedback and responsibilities (a traditional PIII process)....when one side does not have to provide feedback the other side has to 'shoot in the dark' at the proposed target...maybe the word 'repetitive' is a better way to think about it.
In fact, the traditional PIII and SPA are both battlegrounds for positioning toward future claims...one is an informed process, the other is one shell shot gun