EMA Fails to Follow Legislation and Its Own Policy, page-19

CroMagnon,

There are no 'missing studies' so you should not start throwing indiscriminate irons in the fire just to get some fuel for yourself.

TIS has met all the requirements for CE approval (other than the very important answers to the questions in hand) and hopefully that will be received in the first quarter of next year - hopefully earlier rather than later.

NO more trials are required for the CE process - as I am lead to believe.

However, TIS have had initial discussions with the FDA and the jury is still out on final requirements - BUT - they will definately require more detailed testing such as Phase 1, 2 and 3. The final requirements have not been fully outlined and no doubt the company will inform us as soon as they have their final guidelines'

DYOR

Regards...............................