You clearly have no idea how CE Mark works. The submission is essentially rejected in its current form. Saying that they need to get more data for a biotech company is saying that the company should have provided more data in their original submission which is the opposite of what the company said they needed to get approved in the first place. It was a ridiculous strategy to expect to get approved on a handful of patients enrolled by another company a decade ago. Not one patient enrolled since. How much money has this company raised since their listing four years ago? Most of it completely waisted and none of it spent on recruiting patients, contrary to the original prospectus. Only smoke and mirrors from this bunch. Very disappointing. Kenny should resign.
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