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Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S.
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Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50% 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377) p=0.0012.
ANOUNCEMENT OF TEKKEN 7 TRIAL
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19 as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide Merck Plans to Seek Emergency Use Authorization in the U.S. At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died