300% increase, page-14

Wayne has said that the Georgia study is meaningful to the FDA:

"This study is not in the FDA process, but the patients will count in the FDA file that we submit, they have to be. We’re working very closely with the FDA now on our submission.

A lot of US companies use this particular centre in Georgia and the reason you use it, is they do what’s called GCP (good clinical practice) studies, the studies are therefore recognised by the FDA.

Early Feasibility Study – and we’ve been dialogue on this study, it’s not like you just roll in and hand in a file and hope the approve you. We’ve been liaising with them for a good 12 months on the work plan of the studies we have to do and bit by bit we’ve been submitting information and discussing it with them so that we are going to get that approval for the study."

Interview with Wayne in April

I've been through a lot of FDA trials with my investments and it's important to remember that, as Wayne said, there is a continuing back and forth between companies and the FDA when it comes to the different aspects of submissions and trial designs.