Well the positive way to look at this is.....we are still in the game and not rejected.
I think the crux of the matter is that the EMA has not previously dealt with a 'device' that also has pharmaceutical action.The fact that they have been forced by legal means to accept the device classification does not help either.
Oral explanation to be held on Wednesday 25 March 2015 at 11.00, page-24
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