Ann: FDA Strategy and Regulatory Update, page-541

The company has a lot of potential however there may be some necessary changes to the company structure. Previously when the share price was at 40 plus cents the board comprised of strong medical background professionals. In my opinion we require a CEO with a medical background.
Unfortunately the company has had continuous failed attempts and/or withdraws at FDA approval. We were expecting a decision initially for FdA approval for MEB sleep at the end of the September quarter. I understand delays are out of the companies control however if their application is rejected where would that leave us? I believe the non regulated part of the business i.e illumen is their strength at present but is that going to be enough to get the share price moving and investor confidence back?