tell me, have you prescribed Filspari, or have you spoken to...

tell me, have you prescribed Filspari, or have you spoken to proper doctors that have prescribed filspari? I can tell you we have, nephrologists using filspari currently in IgA nephropathy or during clinical trials, and none expressed any big concern about the FDA imposed warnings. Some of this wording imposed by FDA is a legacy of earlier endothelin blockers. We were told the liver monitoring is not a major issue because these patients are having regular blood tests anyway as part of their kidney disease management and they are used to dealing with drugs which show liver enzyme changes. Anyway it looks like some of this is going to be relaxed by FDA. This isn't the first drug to have warnings about usage in pregnancy. The DXB phase 3 trial excludes pregnant women, is that because there is a risk picked up in animal studies that will also end up with a warning?
I agree if acc approval happens there will be companies willing to partner in US, but that hasn't happened yet. The quality of the partner will be key IMO, if it's a company with existing nephrology selling infrastructure then all OK, but if it's like ADVANZ who have no real capability in nephrology then you're having to build this from scratch, which IMO is a big disadvantage especially in market like US. Interesting times ahead that's for certain.