What this is basically saying is that to get CE Mark, they need more clinical data - the opposite of what the company has been saying for the last three years which is that they could achieve CE Mark without the need for additional clinical data. That means that the company has waisted many, many millions of shareholders' money pursuing this failed strategy without having enrolled a single patient since the company's foundation four years ago. What a joke!
What this is basically saying is that to get CE Mark, they need...
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