My opinion is the same as yours Masterchief. A higher calibre, more competent management team would have secured this outcome a lot faster. Let the market never forget that 5 years ago largely the same leadership told the market they considered they had sufficient data to obtain CE mark by Q3 2015 (investor update March 2015). It may be harsh to say but I would argue that if all it took to get the March 2019 negative CE decision reversed was to pull together a literature review/comparison and get some experts in a room to lobby for the company, in my view this could and should have been done and dusted by middle of last year with better management. Now they will be on further hiatus and launch delay due to pandemic, but they have only themselves to blame.
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Ann: Oncosil breakthrough device receives CE Marking approval, page-89
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