They went down the EU route because the path to...

They went down the EU route because the path to commercialisation was supposed to be a lot faster and cheaper than the FDA path. CE Mark is also accepted in other countries (Canada, Australia) without further testing required. FDA trial could then be conducted as the company was earning money from Europe. Also, if you think the CE Mark process has been long and torturous that's nothing compared to the FDA minefield and maze.

Lodging of the study on the FDA register says to me that management are confident that the CE Mark will go through and that TIS will be earning money soon enough to support the FDA trial costs, which I can only take as a positive.

I was here when the CE mark was knocked back at the last minute but from the explanations of the process, the fact that classification is confirmed, no more questions can be asked of TIS, cautiously confident that this time we'll have a happy AGM.