Re: AMRN AdCom
Beyond the 16-0 vote in favor of efficacy and safety, there was considerable discussion about whether the voters would support a broader primary prevention label or just secondary prevention. Group seemed split roughly in half on that point.
As a refresher, the study was powered about 70/30 secondary/primary. When you broke out the subgroups, the secondary prevention group was the only group that had a stat sig result, trend only for primary.
The "secondary only" group seemed to think it had a good chance of working in primary, but that the sponsor hadn't demonstrated it and needed to in a properly powered trial.
The "primary" group kind of argued that this was one trial that should be evaluated as a whole that covered both groups, and it wasn't right to split out and exclude subgroups that were underpowered.
I don't know this section well enough to know what the FDA will do, although I'd lean gently towards a primary label based on cost and safety. Pazdur would limit it to secondary only if it came to him back in the day I would guess. Curious what others may think.
