I have heard DK say that he is confident that this will get the CE mark.
He also said it was imminent.
Why is he confident?
Is this because the company has fulfilled the previous requests of the BSI?
Does anybody know what these requests were?
Is it because Directors initially expected 4-5 resections (10%) heading into the study and it was 24%?
Is this a significant improvement on alternatives?
If CE mark doesnt get approved, we may as well forget FDA, right?
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