This review is not the DSMB safety review. It is a
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Posted On: 09/18/2020 12:30:38 PM
This review is not the DSMB safety review. It is an interim clinical analysis.
These are not the same. Period
The interim results could be great and Cytodyn goes to FDA for approval. They could be mixed and Cytodyn could ask for a trial modification (as many have done during covid), to they could be fine but just require continuation to 390 patients.
As we know, there was not analysis of the data by Cytodyn/Amarex, as the INDEPENDENT DSMC conducted the safety analysis and 'Carry on'.
This is an interim analysis by Amarex/Cytodyn.
These are not the same. Period
The interim results could be great and Cytodyn goes to FDA for approval. They could be mixed and Cytodyn could ask for a trial modification (as many have done during covid), to they could be fine but just require continuation to 390 patients.
As we know, there was not analysis of the data by Cytodyn/Amarex, as the INDEPENDENT DSMC conducted the safety analysis and 'Carry on'.
This is an interim analysis by Amarex/Cytodyn.
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