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Posted On: 12/30/2021 12:15:49 AM
Post# of 148899
Figgs,
The data apparently will be able to be used in a meta analysis of CD12 and recently approved US critical covid trial. On their own, the CD12 critical data were insufficient, principally I believe because they were a subset, not apparently specified in the trial design. Ad hoc data analysis (fishing for good result after the fact) is a good tool to guide additional trials, but not to win approval.
Had Cytodyn conducted separate critical/intubated and severe covid trials, the data would be able to better stand on its own. Recognition of this trial subset after the fact is good evidence for further exploration, but insufficiently rigorous for the FDA.
The data apparently will be able to be used in a meta analysis of CD12 and recently approved US critical covid trial. On their own, the CD12 critical data were insufficient, principally I believe because they were a subset, not apparently specified in the trial design. Ad hoc data analysis (fishing for good result after the fact) is a good tool to guide additional trials, but not to win approval.
Had Cytodyn conducted separate critical/intubated and severe covid trials, the data would be able to better stand on its own. Recognition of this trial subset after the fact is good evidence for further exploration, but insufficiently rigorous for the FDA.
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