I cant remember where i read it either but yes the grant rate is...

I cant remember where i read it either but yes the grant rate is high, and the reject rate low.

Objective statistical inference.
based on no other evidence the odds on our product getting a CE mark real soon is High.
a recentish report by an analyst put it as pretty darn high too
I personally have more 'unknown' in how fast product uptake and market penetration will be.

When i made my buy decisions, my Personal >>opinion<< of the other evidence was that the odds on getting the mark were significantly higher than average. That was based on my best understanding of the case studies I read, and the pretty much total absence (IMO) of complications arising, or plausibly arising. Adding that the treatment is also for people whose quality of life is significantly compromised by the ulcers, the cost risk profile of the stuff seems pretty darn good too.

So when the original rejection of the stuff as a device and reclassification as a something else (drug?) came up as a proposal, I was kinda dumbfounded. (both procedurally and technically) Not only because i thought the classification was a procedurally done deal, but because of the risk benefit analysis above.

So while it is perfectly true that I cant see why a CE mark wouldn't be granted... I also could never see why other things that did happen did happen. I fully expect that on future occasions to see things that I cant see why happening again.
So while that caution caution caution ^^^^^ as disclosure for balance I will disclose that I have made a significantly larger bet on TIS than I have on any other speculative stock ever.

So yeah i cant see why or how the CE mark could even plausibly not be granted. And i hope like hell I am right.

Also thanks Rev. I have much more clarity on what procedurally happens now. Ta.