CE Mark, page-14

Pardon my ignorance, it's been a while since I was totally up to speed here.

There was a question at one stage which was based on whether the scaffold was a device or a medicine. Is this question part of the current process? My worry was that they would judge it a medicine and totally reject the application. Then they would left with the problem of having to fund a US trial as a medicine which would take many more years.

Thanks in advance if anyone knows the answer.

I reckon it is bordering on criminal that these agencies delay life saving products for endless years while people suffer. It happens the world over.... while media talk up great leaps in medicine the man in the street is no better off. No, it doesn't border on criminal it IS.

Anyway, I hold from sub 30c this time around and am trading the trade. One day there will be a company I can buy that actually grows instead of becoming a play thing for traders while the powers that be dither endlessly.