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Posted On: 08/05/2020 12:37:01 PM
Post# of 154134
I disagree. First, we dont know that we didnt meet the primary end point. I dont see any value in making that statement.
More importantly however, the distinguisment between primary and secondary endpoints in a ph2 trial is small. In Phase 2 trials, it is common to have many secondary endpoints, for the purpose of identifying the best endpoints for phase 3.
In Phase 3 the Primary endpoint is the only one that FDA is concerned with. That is NOT the case in Phase 2 trials.
More importantly however, the distinguisment between primary and secondary endpoints in a ph2 trial is small. In Phase 2 trials, it is common to have many secondary endpoints, for the purpose of identifying the best endpoints for phase 3.
In Phase 3 the Primary endpoint is the only one that FDA is concerned with. That is NOT the case in Phase 2 trials.
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