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“This study could turn out to be a pivotal trial,” says Antisense chief executive Mark Diamond.“In other words, if we get the requisite data showing significant clinical improvement in upper limb function, we could submit for European approval.”

My question is -- do we need to show "significant clinical improvement" over baseline? Or do we need to only show "significant clinical improvement" over placebo?

Our IIA trial showed significant clinical improvement over baseline...however I am not confident we will be able to replicate that in this larger trial. There was one significant outlier patient with extremely positive PUL2.0 whose bloodwork was NOT correlated. That outlier, in that small trial, significantly altered our PUL2.0 mean improvement.

I am confident that ATL1102 will show significant clinical improvement over placebo in the Phase IIB, but I think there's a chance ATL1102 might not show significant clinical improvement over baseline.