Another thing for ASIC to think about. On January 29th 2017, the company put out its Quarterly Report with the following statement:
"Following a 1.successful meeting in November the Company now anticipates a CE Mark determination in the next few weeks. The Company remains confident of a 2.successful outcome on its CE Mark."
There was nothing 'successful' about the outcome of the CE Mark determination. Despite this, they have been promoting a successful outcome, specifically CE Mark approval (which means they can start selling in Europe and make big $$$) for at least two years. If they knew all along that the CE Mark body wanted more clinical data, then this is serious sh$t. The only way to know one way or the other is the company to be hit with an 'Aware Enquiry'. Shareholders deserve to know the truth!
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Ann: CE Mark Update, page-46
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