I thought that the primary endpoint in the pivotal
Post# of 154118
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Posted On: 05/04/2019 4:47:05 AM
I thought that the primary endpoint in the pivotal mono trial will be overall efficacy of at least 70%.
Since per 26th March PR, "Approximately 30% of subjects fail within the first 10 weeks of monotherapy on a 525 mg dosage and 17% at a dosage of 700 mg", a responder's rate post-10 weeks of 95% will be 95%*70%=66,5%. Sure with longer overlap, the failures within the first 10 weeks might/will be decreased, but why take the risk and go with 525mg instead of 700mg since there are no safety concerns?
Or did I get that wrong? Can someone clarify?
Since per 26th March PR, "Approximately 30% of subjects fail within the first 10 weeks of monotherapy on a 525 mg dosage and 17% at a dosage of 700 mg", a responder's rate post-10 weeks of 95% will be 95%*70%=66,5%. Sure with longer overlap, the failures within the first 10 weeks might/will be decreased, but why take the risk and go with 525mg instead of 700mg since there are no safety concerns?
Or did I get that wrong? Can someone clarify?
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