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CLEO Diagnostics Ltd ( (AU:COV) ) just unveiled an update.
Cleo Diagnostics Ltd has made significant progress in its regulatory activities, receiving positive feedback from the U.S. FDA during its second pre-submission meeting. This feedback will help enhance the robustness of its clinical trial design and data collection processes, reducing regulatory risk for its upcoming 510(k) submission. The company has also secured approximately 1,600 biobank samples from various sources, which will support its FDA submission and accelerate the development of its screening and recurrence tests. These samples will provide a strong scientific evidence base and facilitate the refinement of their Pre-Surgical Ovarian Cancer test.
More about CLEO Diagnostics Ltd
Cleo Diagnostics Ltd is a company specializing in ovarian cancer diagnostics. They are focused on developing a simple and accurate blood test for the detection of ovarian cancer, with a significant emphasis on entering the U.S. market.
Average Trading Volume: 171,039
Technical Sentiment Signal: Strong Buy
Current Market Cap: A$52.69M
Find detailed analytics on COV stock on TipRanks’ Stock Analysis page.