redfaces, page-6

And to add to what you have said, and to state the obvious Redfaces, the reason Phase IIb and Phase III trials are required, is that it hasn't been proven conclusively that it works with a variable group of women, of different ethnic groups living in different countries and what effect if may have for people taking different drugs and having other conditions.
If we knew it worked and was safe it would be already on the market. There is evidence to suggest that CVAC has potential and it is now upto PRR to prove this. 30 people and the previous trials that have been completed are not enough.
So some people saying that it is a foregone conclusion don't obviously understand the risks still associated with trying to be successful in Phase IIb or Phase III.