AVR 0.80% $18.90 anteris technologies ltd

Ann: Notice of Annual General Meeting/Proxy Form, page-10

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    "Because they still have to submit the results of the feasibility study to the FDA to get clearance for the pivotal trial..."

    Please excuse my laziness, as I am sure that the answer to my question lies in a report somewhere, but if this trial going on now isn't an FDA approved "pivotal trial", what is it?
 
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