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Re: Henkel post# 40328

Friday, 08/13/2021 3:00:44 PM

Friday, August 13, 2021 3:00:44 PM

Post# of 43837
Looking at a letter from the FDA to Cyto Dyn (CYDY), they make this statement. I wonder if this will apply to CVM? I'm not short, nor do I intend to be.

"... If the analyses of the primary and secondary endpoints do not support conclusions of the medicine’s benefit, then FDA considers subgroup analyses to be exploratory, meaning they may inform the design of future trials, but do not support reliable conclusions about the medicine’s benefit. Focusing on only the most favorable of many subgroup analyses,

even if the sub-groups are pre-specified,

can lead to overestimating the evidence of benefit, because regardless of a drug’s true efficacy, some analyses are likely to appear favorable by chance when a large number of analyses are conducted. "

https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab
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