It looks like these guys took a different approach to getting to...

It looks like these guys took a different approach to getting to market. They went straight to the main market is the USA. If TIS had done the same then we also would have been in market there by now. Instead TIS tried to squeeze through the back door with a dodgy application. I read in the Courier mail Mercers comments after the AGM and how he/TIS has been caught up in a European power struggle of some sorts. I'm surprised he has poked his head up in an attempt to blame others, as the situation rests 100% on the management and the decisions it has made. The fact that the EMA wasn't even going to accept the product as a rule 13 indicates the absolute folly of trying to get it through under a rule 8. And don't blame BIS. It was managements call all along. Of course its only natural to shift the blame.
I wonder about this perception of some answers didn't have to be answered till after the CE mark was granted. If it was in writing then the game can't be changed half way through. Not even the EMA could do that. I think it its another example of incompetence. Where did they get this perception from? One of their expert consultants. They should known by now that if they think the EMA may be out to make life difficult then you don't offer them opportunities, which they have done so.
These guys should be working weekends to get this in in November. But they won't.

If this company has relied on expert consultants to guide them along over the past years I would like to see an example of where some advice may have been proved to be accurate and effective, because it is difficult to imagine a scenario that every step could have been more screwed up than it has been. If they have based their decisions on these experts/consultants then I strongly urge the company consider using my cat in the future. It may just say Meow, but at least its not incorrect advice.

Don't blame others "management". The situation rests only on you and the decisions you have made.