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Posted On: 08/12/2020 4:18:16 PM
Post# of 151654
• Cytodyn request FDA EUA for M/M population due to CD10 trial data
• NEWS2 statistically significant (secondary endpoint) 2.5x better than placebo
• 70% SAE, AEs from study in placebo arm
• P3 study if no EUA from any country (~ 75-85 patients) due to NEWS2 score being already achieved and safety already established
• NEWS2 statistically significant (secondary endpoint) 2.5x better than placebo
• 70% SAE, AEs from study in placebo arm
• P3 study if no EUA from any country (~ 75-85 patients) due to NEWS2 score being already achieved and safety already established
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