my opinion

Here's my 2 cents worth,

TIS knew that there was controversy re medicine or device classification from day 1.

TIS proceeded down the device path with the hope it would be easier or quicker as apposed to going down the medicine road.

TIS management failed to put the fine tooth comb over their final submission to BSI for EMA submission. Surely if they were not sure they should have got there submission looked over by an independent expert who is very familiar with EMA processes/expectations BEFORE lodgement.

EMA comes back saying the submission from BSI was "poor".

For this to happen is everyone's worst nightmare and our only distant hope now is that EMA may still come out with a ruling in favour of granting CE Mark.

Bottom line this management failed and somebody needs to answer questions. The investors and SP have been smashed and we have no announcement guidance from TIS about what is being done to remedy this issue. THe CEO at a minimum needs to step aside fall on his sword. The buck stops with him for failing to ensure that our submission was checked, re - checked and triple checked.fundamental stuff!

Awaiting answers from the co. about where we sit and where we go from here. As usual, Comms are non existent. Not happy Jan!

Surfrat