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Sunday, 10/10/2021 11:04:42 PM

Sunday, October 10, 2021 11:04:42 PM

Post# of 44690
ZYESAMI has demonstrated a statistically-significant reduction in mortality rate when compared to placebo in treating critical COVID-19 and respiratory failure in patients, which used a written statistical analysis methodology agreed in advance with the FDA that controls for differences in baseline severity of disease. If one does not control for baseline severity, a numerical but not statistically-significant advantage is observed. ZYESAMI has been approved for Emergency Use by the Nation of Georgia with pending applications in surrounding Caucasus nations and has been submitted for “Emergency Use Authorization” (“EUA”) to the FDA, where it is awaiting a regulatory decision. Applications to other regulatory authorities worldwide are currently in process. Additional Phase III trials of ZYESAMI are now being conducted by the U.S. National Institutes of Health (“NIH”) and by an entity funded by the U.S. Biomedical Advanced Research and Development Authority (“BARDA”).

https://seekingalpha.com/filing/5708277