Ann: Update - CE Marking Application, page-68

For starters if it was such it was all a misunderstanding the company should have gone into suspended trading until its all clarified.
The oversight committee have assesed the strong data package and determined it to be insufficient clinical benefit. BSI is going to have to agree for now with the oversight committee. Do they all agree to do another trial to try and achieve clinical benefit if possible. Where did the original trial fail to achieve clinical benefit ??.

"The Clinical Oversight Committee has determined that at this time insufficient clinical benefit has been demonstrated to recommend approval. The Clinical Oversight Committee will now send this recommendation to BSI’s Medical Device Group for final determination. Although the Company is still assessing the feedback to determine the next steps, on its initial assessment it is extremely disappointed with the determination given the strong data package that was presented. The Company will look to clarify the issues with BSI and update the market when a course of action has been formulated."