American Invest Hub
  • Politics
  • Investing
  • Business
  • Latest News

American Invest Hub

  • Politics
  • Investing
  • Business
  • Latest News
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
Why Europe’s youth are flirting with the far-right

Related Posts

American Express stock has upside, but a pullback...

September 21, 2024

Copper price forecast: US election, China stimulus in...

November 5, 2024

Best Solana crypto coins to buy as SOL price...

March 5, 2025

Axon Enterprises stock surged but faces one key...

January 5, 2025

Retire rich with these blue-chip dividend ETFs

January 25, 2025

DXY index analysis: Here’s why the US dollar...

December 20, 2024

Progress Software shares up 6% after impressive Q3...

September 26, 2024

USD/JPY forecast: signal as the Japanese yen crash...

October 28, 2024

​Tech 5: Recession Fears Kick Panic Selling into...

August 10, 2024

Norfolk Metals

April 30, 2024

    Stay updated with the latest news, exclusive offers, and special promotions. Sign up now and be the first to know! As a member, you'll receive curated content, insider tips, and invitations to exclusive events. Don't miss out on being part of something special.


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

    Latest News

    • Kraft Heinz plans breakup, weighs $20 billion grocery spin-off: report

      July 13, 2025
    • Trump’s 50% tariff on Brazil imports to brew trouble for Starbucks and Dutch Bros

      July 13, 2025
    • US to announce 30% tariff on EU and Mexico says Trump

      July 13, 2025
    • Why India is rushing to build bigger banks and what’s standing in the way

      July 13, 2025
    • Wall Street braces for weakest earnings season since 2023 amid market highs

      July 13, 2025

    Categories

    • Business (3,388)
    • Investing (2,615)
    • Latest News (2,017)
    • Politics (1,530)
    • About us
    • Contact us
    • Privacy Policy
    • Terms & Conditions

    Disclaimer: americaninvesthub.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 americaninvesthub.com | All Rights Reserved