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Posted On: 03/22/2019 12:34:22 PM
Post# of 150040
SJ - I believe that induction period now should be not 6 wks but at least 8.
Before in 6 wks , patients took for the first one week both HAART and Leronlimab
Company noticed that at the end of this 6 weeks they really don't see more failing , so it was 5 weeks only on Leronlimab
Now with longer overlap of 3 weeks when we add 5 weeks , the induction period will be 8 weeks or little longer if that what they will decide.
This is no big deal if efficacy is better.
I also think that if pivotal will be in 2 parts , induction and maintenance ,
maintenance will be 24 weeks.
48 they will do only if there is one part of study as is our phase 3 at present.
As always IMO only.
Before in 6 wks , patients took for the first one week both HAART and Leronlimab
Company noticed that at the end of this 6 weeks they really don't see more failing , so it was 5 weeks only on Leronlimab
Now with longer overlap of 3 weeks when we add 5 weeks , the induction period will be 8 weeks or little longer if that what they will decide.
This is no big deal if efficacy is better.
I also think that if pivotal will be in 2 parts , induction and maintenance ,
maintenance will be 24 weeks.
48 they will do only if there is one part of study as is our phase 3 at present.
As always IMO only.
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