Genedrive® CYP2C19. CE-IVD application exoected >>15 Apr 2025 11:11
"Market access routes and reimbursement strategies defined in key initial international target countries, including the Middle East region, with well-positioned and aligned in-country distributors, with required regulatory certification (CE-IVD under IVDR) on track for April 2025".
Followed by:-
"510(k) route identified for regulatory submission for US market entry, with initial pre-submission engagement with Food and Drug Administration (FDA) held and feedback positive and with regulatory approach confirmed as appropriate".
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Why the sp is up 2.63% I suspect.