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Floyds - they don't need to do additional studied for the CE...

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    Floyds - they don't need to do additional studied for the CE Mark - my expectation is that this is on the path to being granted.

    They need to do additional work to get a scientific opinion. Reading the announcement again the panel was happy with the safety and effectiveness of the product. There is just an issue with one component of the product, and the EMA are going to sit down with TIS and agree on a pathway to achieving this in May.
 
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