Nice appointment, page-16

BB - the CE process IS taking far longer than the company has said. Over and over again. Last years report states CE mark in Q3. We have OSL telling us that they expected it in Oct, then Nove and then EOY, Now it is 1st 1/4 this year.

I understand the machinations involved with a CE mark, and that sometimes there are 'opportunities' to further explain to the NB. However now being some 3 months later than first suggested, by OSL do you not think it appropriate for OSL to notify SH what the current stays is?

It may be dead, or not. Technically it is ever dead as long as the client wishes to spend the time and money in their pursuit. But 3 or 4 months post the expected date of a 'fast track' application says there is a problem somewhere. You don't need inside information to deduce this.

In regard to the IDE - well I think the days limit is probably about up for the FDA to reject. So if not rejected they have the IDE, as per guidelines. Something tells me that the day the IDE is granted, we will all know about it. You would have to check to see how the 45 day limit is counted e.g. does it exclude a Xmas break etc. But we are getting close, whichever way the days are counted. I assume that OSL would notify the market ASAP as granted or a rejection.

There may be some posts you don't like, and in particular the style of posting. But when posters are attacked you must expect the style to be less than conciliatory?

Now having got that out of the way, lets enter a reasonable debate about the CE and IDE.

What is your view regarding the delay of the CE and the impending deadline for the IDE, if indeed not already passed?