Aug. 13 at 11:12 PM
$NGEN A fascinating key detail for me is the 1–10 years post-injury, mean 3.5 years. Natural-history literature shows that most spontaneous motor recovery after traumatic SCI occurs during the first 6–9 months & generally plateaus by about 12–18 months. CONNECT wasn’t taking ppl 3 months after an accident, when substantial natural recovery could contaminate the result. These people were, on avg, yrs removed from injury.Against that background, the gait analysis found: 10/10 NVG-291 patients met the responder criterion 1/10 placebo patients met it. Responder comparison: p ≈ 0.0001 Overall multivariate gait effect: p = 0.0197 Coordination: p = 0.007
Mechanical effort: p = 0.038
Postural stability: p = 0.044
& there’s an important technical detail: “responder” wasn’t simply “the patient walked a bit better.”
$NGEN SEC filing says a responder was someone who outperformed the majority of subjects in the opposite treatment arm across the composite of coordination, effort and stability.
