Well, in part, it IS a learning experience. This is the first...

Well, in part, it IS a learning experience. This is the first product that TIS has brought to market. Sure, they could have done the testing and then licensed it off to an established pharma company, with divisions devoted to bringing new products to market quickly. But that's not what I suspect most of us are in this game for.

Instead, We paid BIS to consult and guide us through the CE Mark process (look what happened there).

My only regret for the company is that they didn't bite the bullet sooner and raise cash for the FDA process sooner. When your fate is in the hands of an external body, and what you are left to do amounts to a waiting game, reacting to the regulatory body's questions, maybe the guys should have taken a bit more control of the company's destiny and pushed on with the FDA approval, even if it meant more dilution in the process.