Sep. 26 at 3:42 PM
$ORGO •
🧾 AI analysis:
1. Consistency of direction
• Trial 1: met primary endpoint (p=0.0177).
• Trial 2: numerical benefit, narrowly missed prespecified alpha (p=0.0393 vs 0.023).
• Both show directionally consistent benefit.
2. Pooled analysis
• Pre-specified IPD pooled SAP: combined data statistically significant for pain reduction.
• Clinically meaningful effect size: ≥0.5 WOMAC units → exceeds MCID thresholds.
3. Responder rates
• ≥30% and ≥50% pain reduction responder rates: strong separation vs saline,
• significant improvement in function (Trial 2 function endpoint p<0.0001).
• safe: no RPOA, no accelerated structural damage, no new safety signals.
• Favorable compared to corticosteroids, HA injections, and prior NGF inhibitors.
• RMAT designation demonstrates FDA recognition of unmet need
• Willing to accept narrower initial label (e.g., severe OA KL3–4) if that eases approval.
• Commitment to post-marketing confirmatory trial to strengthen long-term data.
