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Posted On: 02/01/2022 4:13:38 PM
Post# of 148884
Re: onestepahead #117069
Onestepahead,
You may be correct that the trial enrollment size is in fact being reduced. As the update was posted January 4, four weeks after the referenced PR, I made the assumption that Cytodyn was continuing with the original trial size.
This could reflect anticipation of increasing cases ensuring better access to trial participants, desire of ANVISA to continue as planned, or recognition that the FDA has failed to act on positive results from small trial populations.
Then again, maybe Cytodyn is taking the short path to trial data. I hope not, as even with four doses, the risks are higher within a smaller trial size.
You may be correct that the trial enrollment size is in fact being reduced. As the update was posted January 4, four weeks after the referenced PR, I made the assumption that Cytodyn was continuing with the original trial size.
This could reflect anticipation of increasing cases ensuring better access to trial participants, desire of ANVISA to continue as planned, or recognition that the FDA has failed to act on positive results from small trial populations.
Then again, maybe Cytodyn is taking the short path to trial data. I hope not, as even with four doses, the risks are higher within a smaller trial size.
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