Investing News NetworkJune 25, 2024Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce progress in its regulatory strategy for its first commercial product, the pre-surgical triage test. Highlights Initial pre-submission meeting held with the U.S.

。重点介绍与美国举行的首次提交前会议。

Food & Drug Administration (FDA) where CLEO outlined its submission framework and clinical planPositive feedback from FDA provides confidence in CLEO’s U.S. regulatory strategyClinical trial design receives Institutional Review Board (IRB) approval in both U.S. and Australia Commencement of U.S. Regulatory ProcessCLEO has completed an initial pre-submission meeting with the U.S.

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Food and Drug Administration (FDA) where the Company outlined its submission framework and clinical plan for its ovarian cancer detection blood test. The pre-submission meeting is designed to permit CLEO to receive early guidance from FDA review teams prior to an eventual application submission.The meeting was interactive with the FDA providing constructive and positive feedback on CLEO’s approach to obtaining regulatory approval in the U.S.

食品和药物管理局（FDA），该公司概述了其卵巢癌检测血液测试的提交框架和临床计划。提交前会议旨在允许CLEO在最终提交申请之前尽早获得FDA审查小组的指导。会议与FDA进行了互动，就CLEO在美国获得监管批准的方法提供了建设性和积极的反馈。

for its ovarian cancer detection blood test. This outcome provides confidence that CLEO's clinical trial designs and strategic direction are appropriately aligned with FDA requirements.Early interaction with the FDA is important as a part of CLEO’s U.S. market access strategy for a number of reasons, as the guidance outcomes allow CLEO to:Refine its clinical trial design to maximise resourcing and quality of data;Reduce the possibility of rework;Shorten the potential timeframe to application submission; andOperate with an open and transparent approach.

对其进行卵巢癌检测血液检测。这一结果为CLEO的临床试验设计和战略方向与FDA的要求相一致提供了信心。由于许多原因，作为CLEO美国市场准入战略的一部分，与FDA的早期互动很重要，因为指导结果使CLEO能够：改进其临床试验设计，以最大程度地提高资源和数据质量；减少返工的可能性；缩短提交申请的潜在时间；并以公开透明的方式运作。

CLEO is pursuing expedited FDA approval for its first ovarian cancer detection product - the pre-su.

CLEO正在寻求FDA对其首款卵巢癌检测产品pre-su的快速批准。