RE: NASDAQ ADR’s17 Feb 2022 17:32
This is an interesting point. From the FDA's perspective, although Filsuvez was not as effective at the 90 day point there was significant efficacy demonstrated at the primary endpoints. Considering the fact that the safety profile was good and there is no other approved therapy, I find it hard to see how they won't approve based on the AMRYT push to have KOLs on EB involved from an early stage. If patient advocacy groups are saying we want this and it is safe, surely that is better than no treatment at all.Then again, what do I know, the FDA approved OxyContin for headaches.