More relevant for RVX is the news today on Vertex.  Their drug, Trikafta was approved several months before even Vertex expected!  Usually the FDA dragged its feet when there was an existing "cure" in place.  But cystic fibrosis already has 3 (very expensive) drugs in use.  So the FDA may be wanting to bring more competition in place for that disease.

This is an FDA that means business.  I think the mood now in the FDA is "we will approve it if we can get away with no controversy".  I am willing to bet that the FDA will give a positive hearing to RVX.  If the written comments are effectively "we will approve it if more patient years show CI 95%"...then RVX immediately becomes a buy out candidate.  And why won't the FDA?  I can't see any other option for the FDA, particularly given the "safe enough for chronic drug use" comment from RVX.  

The caveat of course, is that my assumption of it only being a statistical issue of too few patient years is correct.