Quote:1 early termination which also counts as a failure per
Not counted in the "viral failure" group, it is possible to terminate and still have a suppressed viral load.
Quote:They say they want to enroll additional 200 pts across all 3
Only across the 525 vs 700 group, dose-response study showing the effectiveness without placabo if there is distinguishable results. This is 100 525mg vs 100 700mg, which they have already enrolled most, starting last year. I posted this week here how many at least they currently have at 700, some were enrolled in February.
Quote:Why not simply enroll them to 700mg only?
This 200 additional pts above 300 started last year, not now, 525 vs 700 random in dose-response study. I posted here early the fda guidebook talking about this. Also 525 is still viable. Most failures happen early, not randomly throughout the trial, so they are going to add a 5x half-life overlap bring leronlimab to steady-state before stopping haart. Also switch to induction/maintenance, which will change success/failure.
Quote:
Safety wise, we had 30 SAE incidents in total of 387 pts or 7.75%, where it is unknown whether these were definitely or probably related to PRO 140.
This is probably OK, but have no details about the nature of the SAEs yet.
It says: "None of the reported SAEs were definitely or probably related to PRO140(leronlimab)"
