CE Mark Odds, page-12

BSI is a profit-oriented business. All the time they have a willing customer who can pay the bills they will continue the relationship. In fact the longer it goes on the more $ they make.

I think that any view of BSI 'giving a second chance' is rather naive, to say the least. To suggest that they must have been very close is a fundamental misunderstanding of how the process actually works.

I do hope they get the CE Mark, and are able to achieve good data in the trials. However, as many of us discovered with SRX clinical trials for cancer radioactive devices is a minefield. Of course, as with SRX and BTG (UK), successful businesses can be built even in the absence of outstanding trial data.