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|refused to submit||提出を拒否した|
|required to submit||提出する必要があります|
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TMDX completed their OCS Liver PROTECT Trial on time despite the recent COVID-19 issues, and as of their Q1 conference call on May 6, 2020 was planning to submit a PMA to the FDA “within the coming weeks.” Internationally, the business has no set reimbursement policies with payers in Europe or Asia, so incremental adoption will be a steeper hill to climb than in the U.S. where reimbursement is already established under OCS Lung, which sets the stage for similar reimbursement for OCS Heart and OCS Liver.