OSL oncosil medical ltd

Ann: Update - CE Marking Application, page-27

  1. 117 Posts.
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    A couple of facts about the BSI regulatory process to date at OncoSil;
    1. BSI told Oncosil in August 2014 that to secure CE approval an RCT was required, demonstrating safety, efficacy and clinical benefit - I can request a copy of this correspondence to be sent to you, I can't make any promises
    2. At least 2 staff members were told to "get on board or get out" when they challenged the decision not to disclose this information to the stock market and voiced concern re: telling the market CE approval was imminent knowing it was not only not imminent, but impossible
    3. BSI made it exceptionally clear that 20 patients was a pilot safety study only, that the outcomes no matter what they were would not support CE approval
    4. The board and c-level staff ... well we all know the decisions they made
 
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