Cleo Diagnostics (ASX:COV) received positive feedback from the US Food and Drug Administration (FDA) at the second pre-submission meeting for its ovarian cancer pre-surgical triage test, according to a Monday filing with the Australian bourse.
The feedback will help the company improve the robustness of its clinical trial design by strengthening data collection processes for a high-quality submission, the filing said.
Shares rose 9% in midday trade Monday.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.