Replies to post #185750 on Biotech Values

[genisi]

>>BIIB anti-LINGO drug

What if anything should we understand from meeting the primary endpoint and missing the secondary end points?

I think data on the primary endpoint from this proof-of-concept trial did detect a signal of remyelination. Why was this signal detected via functional electrophysiological measures (VEPs) but not the secondary endpoints both functional (LCLA) and structural (OCT-assessed RNFL thickness) measures, I don't know. Perhaps allowing newly diagnosed MS patients (based on the current episode of AON and positive brain MRI results) in the trial was a problem because the trial design assumes the unaffected fellow eye is normal, which usually is the case in patients with AON as a clinically isolated syndrome but often is not so in the presence of MS.

Does it raise doubts about the ability to remyelinate?

To me it raises doubts about the ability to detect remyelination and to demonstrate clinically relevant benefit on vision as well as structural preservation.