1 early termination which also counts as a failure

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)"