Thursday, October 17, 2019 11:58:33 AM
Another key issue might be that the new European MDR regs may require a higher standard of clinical proof than is required for a US FDA 510(k) for a Class II topical wound dressing. ARTH had said nothing about this subject to date (other than to state that no new questions have been posed), so one can reasonabley assume that the new MDR regs are not introducing new issues. However, ARTH's silence on all matters encourages speculation.
In the meanwhile, $2.5MM will support the executives' and directors' cash compensation requirements.
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