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Posted On: 08/06/2020 3:34:24 PM
Post# of 149007
Lorbas,
You are absolutely correct that the SAE PR was a mess, botching a great opportunity.
The DSMC evaluation is, apparently with rare exception of extraordinary demonstration of efficacy, a binary event of trial stops due to safety risk to trial participants or trial continues.
Data is not disclosed to Cytodyn, this no data in PR. We have to wait for 195 patient interim analysis.
The PR was succinct and objective, indicating that Cytodyn passed a milestone which has stopped them trials of many other therapeutics.
So yes, the DSMC PR was completely appropriate e and a huge improvement over m/m safety SAE PR.
You are absolutely correct that the SAE PR was a mess, botching a great opportunity.
The DSMC evaluation is, apparently with rare exception of extraordinary demonstration of efficacy, a binary event of trial stops due to safety risk to trial participants or trial continues.
Data is not disclosed to Cytodyn, this no data in PR. We have to wait for 195 patient interim analysis.
The PR was succinct and objective, indicating that Cytodyn passed a milestone which has stopped them trials of many other therapeutics.
So yes, the DSMC PR was completely appropriate e and a huge improvement over m/m safety SAE PR.
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