This is an old document - old in the sense that once TIS got the device ruling it was clear that the above referenced scientific opinion was an integral part of the approval process. It is extremely unlikely that TIS's management was not aware of this document and its implications. Of course, they could have been made aware just a couple of month's ago and that may tie in with the veiled warnings in the announcements. If they did know - and I think we can safely assume that, then it does put the latest CR in an entirely new light. If they didn't then they are truly incompetent (excluding the Chief Scientific Officer).
TIS Price at posting:
10.5¢ Sentiment: Hold Disclosure: Held