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Monday, October 11, 2021 5:10:11 PM
Naw, any DEBUNKED outdated info will suffice as tout material no matter what the FDA publicly said.
CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.
https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?Mon,%2017%20May%202021%2014:59:28%20EDT
CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.
https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?Mon,%2017%20May%202021%2014:59:28%20EDT
Recent CYDY News
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- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 04/08/2026 09:15:18 PM
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