Aug. 14 at 2:15 PM
$IMNN Final points from AI:
"On the Phase 2 data: Tier 1 — primary endpoint, ITT. PFS, the pre-specified primary, came in at HR 0.79, roughly a 3-month improvement. That's modest. Tier 2 — secondary endpoint, ITT. Median OS of 45.1 versus 30.4 months, the 14.7-month figure. This is a legitimate randomized, all-comers comparison. It's the strongest thing they have. The caveats are that it was a secondary endpoint in an open-label trial of ~112 patients that was not powered for significance, so it's a real signal but not proof. That number that should govern expectations for Phase 3, because OVATION 3's primary endpoint is OS in the full population. If the effect is closer to 14.7 months, the trial can work....Asked directly about HRD-positive versus HRD-negative screening, Faller said patients have been enrolled essentially equally. So they're running an all-comers trial, which is the methodologically correct choice and meaningfully better than what Celsion did with OPTIMA."
