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Replies to post #27615 on MindMaze Therapeutics Holding (RLFTF)
"...today announced that, after a strategic review of the [their] clinical trial that included an assessment of the evolving COVID-19 treatment landscape, feedback from the U.S. Food and Drug Administration (FDA) and an interim analysis of the [their] study data, it has elected to discontinue the trial. Importantly, [their drug] was generally well tolerated and there was no adverse safety signal reported in the [their] trial.
In response to the medical community’s rapidly evolving understanding of COVID-19 disease progression and approaches to treatment, [other company] recently submitted a revised [their] trial protocol and received feedback from the FDA regarding the regulatory and development path in COVID-related ARDS. For [their drug] use in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and ARDS, the FDA highlighted the likely need for additional clinical trials with sufficient sample size to adequately assess mortality risk. Based on this feedback, [other company] determined that it would be unlikely that the 70 patients targeted for enrollment in each of the [their] trial’s treatment arms would be sufficient in size to adequately evaluate mortality and that at least one additional clinical trial with a mortality endpoint, which would require significantly more patients, would be required for approval of [their drug] for use in patients diagnosed with COVID-19.
10/23/20 1:30 PM
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