Sport Investors League
  • Politics
  • Stocks
  • Investing
  • Business

Sport Investors League

  • Politics
  • Stocks
  • Investing
  • Business
Investing

Cleo Commences U.S. Regulatory Process with FDA

by admin June 27, 2024
June 27, 2024
Cleo Commences U.S. Regulatory Process with FDA

Ovarian 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. Food & Drug Administration (FDA) where CLEO outlined its submission framework and clinical plan
  • Positive feedback from FDA provides confidence in CLEO’s U.S. regulatory strategy
  • Clinical trial design receives Institutional Review Board (IRB) approval in both U.S. and Australia

Commencement of U.S. Regulatory Process

CLEO has completed an initial pre-submission meeting with the U.S. 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. 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; and
  • Operate with an open and transparent approach.

CLEO is pursuing expedited FDA approval for its first ovarian cancer detection product – the pre-surgical Triage test – via the 510(k) application pathway. This approach provides the quickest pathway to achieve regulatory approval for devices that achieve ‘substantial equivalence’ to an existing predicate.

Clinical Trial Activity

CLEO’s clinical trial design has now been reviewed and approved in both the U.S. and Australia. Institutional Review Board (IRB) approval is a legal requirement for any clinical trial, to ensure trial activities are ethically sound and compliant with federal regulations.

Trial sites are being formally contracted, and patient recruitment is to commence shortly. CLEO is working with U.S.-based Contract Research Organization (CRO), Lindus Health to manage the international arm of the trial.

Click here for the full ASX Release

This post appeared first on investingnews.com

0
FacebookTwitterGoogle +Pinterest
previous post
Sarama Completes Tranche 1 Equity Placement and ASX Cleansing Notice
next post
‘It’s just obscene’: House eyes crackdown on US dollars going to Taliban

Related Posts

Investing in Graphene Companies (Updated 2024)

August 1, 2024

Sona Nanotech to Showcase Its THT Cancer Therapy...

November 8, 2024

Crypto Market Update: Ethereum Funds Draw US$2.12 Billion...

July 22, 2025

LaFleur Minerals to Restart Gold Milling at Beacon...

March 1, 2025

Crypto Market Recap: Bybit Investigates Lazarus Hack, SEC...

February 27, 2025

Tech 5: US Lifts EDA Restrictions for China,...

July 6, 2025

NorthStar Gaming Announces Results of Annual Meeting and...

June 3, 2025

Copper Prices Surpass US$10,000 as US Tariff Fears...

March 22, 2025

Alice Queen

August 22, 2025

Top 5 Canadian Mining Stocks This Week: Noble...

March 16, 2025

    Get free access to all of the retirement secrets and income strategies from our experts! or Join The Exclusive Subscription Today And Get the Premium Articles Acess for Free


    By opting in you agree to receive emails from us and our affiliates. Your information is secure and your privacy is protected.

    Recent

    • ‘Doctor Strangelove with a mustache’: Bolton blasted for ‘profiteering’ off US secrets by White House advisor

      August 27, 2025
    • EPA urged to axe funds for ‘radical’ climate project accused of training judges, state AGs rally

      August 27, 2025
    • Bolton may be in hot water as FBI investigation expands beyond controversial book

      August 27, 2025
    • EPA urged by state AGs to axe funds for ‘radical’ climate project accused of training judges

      August 27, 2025
    • Intel rival SkyWater pitches itself as all-American firm as Trump mulls more equity deals

      August 27, 2025

    Categories

    • Business (1,083)
    • Investing (2,915)
    • Politics (3,567)
    • Stocks (1,155)
    • About us
    • Contact us
    • Privacy Policy
    • Terms & Conditions

    Disclaimer: sportinvestorsleague.com, its managers, its employees, and assigns (collectively “The Company”) do not make any guarantee or warranty about what is advertised above. Information provided by this website is for research purposes only and should not be considered as personalized financial advice. The Company is not affiliated with, nor does it receive compensation from, any specific security. The Company is not registered or licensed by any governing body in any jurisdiction to give investing advice or provide investment recommendation. Any investments recommended here should be taken into consideration only after consulting with your investment advisor and after reviewing the prospectus or financial statements of the company.

    Copyright © 2025 sportinvestorsleague.com | All Rights Reserved