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Posted On: 02/24/2021 8:29:34 AM
Post# of 153936
Hulk67,
Breeze woods friends believe, without any direct knowledge, that the discussion is based on secondary endpoints.
An alternative explanation is the primary endpoints were hit and that discussions are about managing allocation. If approval (normal with primary endpoints hit) is granted, fda loses ability to prevent off label use (mild/moderate, hiv, cancer) and the supply for severe Covid will be likely be diminished.
Either scenario is possible. DSMb continuation of Cd12 without modification leads me to believe primary endpoint with statistical significance was achieved.
Breeze woods friends believe, without any direct knowledge, that the discussion is based on secondary endpoints.
An alternative explanation is the primary endpoints were hit and that discussions are about managing allocation. If approval (normal with primary endpoints hit) is granted, fda loses ability to prevent off label use (mild/moderate, hiv, cancer) and the supply for severe Covid will be likely be diminished.
Either scenario is possible. DSMb continuation of Cd12 without modification leads me to believe primary endpoint with statistical significance was achieved.
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