Also remember this will be a global, pivotal registration study which will involve study sites in both the US and the EU. The study results will be included in regulatory submissions to both the FDA and the EU regulatory authorities for market approval (as opposed to running 2 separate studies). Anteris will pursue both submissions in parallel. If CE approval occurs prior to FDA approval, then sales could commence in Europe.
Also remember this will be a global, pivotal registration study...
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$6.03 |
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Mkt cap ! $93.45M | |||
| Open | High | Low | Value | Volume |
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| Last trade - 15.36pm 20/06/2025 (20 minute delay) ? |
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