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TIS 0.0¢

Uncoupling EMA and FDA - A positive step

  1. Revreboot

    468 Posts.
    I finally got around to reading the investor presentation that has just been released. I was pleased to see TIS moving forwards despite the delays ingaining CE Mark and the potential for EMA to further delay that approval. In their words they have uncoupled the progression to FDA trials from the EMA result and plan to forge ahead with those trials beginning in the second half of the year. Of course the ideal is still to received CE mark and start sales in Europe in the short term but at least moving into the US market is no longer dependent on that outcome. A sensible and perhaps overdue plan IMHO.


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