Ann: CE Mark Update, page-257

My god this is being drawn out isn’t it! Intentionally? They were failed last March as all current and former SH know, and I’d understood this would be a binary thing ....either they convert BSI’s position on the product from “insufficient” benefit to “sufficient” benefit or they do not. And With no significant new trial data I was told. Perhaps their brilliant seismic ‘look we’re life prolonging and better than all the rest’ revised submission has been taken apart again. Perhaps BSI want to know why in almost half the implanted patients in panco the radioactive stuff appears not to stay fully where it should (fact: OSL’s own data posted on their website under presentations). Could be a critical product design flaw. (I wrote to osl about this and received no reply)
Does anybody know what’s going on?
whether this company is on a path to eventual CE success or another failure they’re really taking the scenic route. Homo sapiens will have evolved into the next phase on the evolutionary path and osl will still be talking about CE imminent and having great meetings with BSI.
could this be the slowest CE on record?