Thanks Eire.
I'd like to know if the valve-in-valve revenue postulated for 2024 is expected to come from the DurAVR being awarded a Humanitarian Device Exemption by the FDA. If so, why would the FDA grant a Humanitarian Device Exemption to an unapproved device when there are approved devices already being used for the procedure? The lack of a comparable device is a requirement for the exemption.
AGM questions for submission to management, page-4
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