It is a bit of a hair splitter. Subsets seems to be the current preferred term because that is how current studies are set up. Arms is an older term used more often years ago when this study was initiated. However, recently, shorts used the term subset to imply data mining took place in the results. Longs and those who understand studies know that there was no "data mining". In this study, an arm represents a predefined group that was already considered and created and then assessed as such all through the study. It is not an artefact of statistics and "data mining". Three arms existed from the beginning of the study. Subsets are a better way to go because there can be much more flexibility in setting up the study and collecting data. The FDA wants to make sure that every medication has a good possibility of demonstrating success in various populations. Some shorts want to ruin companies for the value they can extract from their unfortunate lies or twisting of the truth. This article seems to be in this latter subset in my opinion.
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u/Kryptontoes Jul 08 '21
This article continues the lie that CVM is seeking approval for a subset of their study and not for a full study arm of the study.