Can anyone tell me why it is such a big negative to be with the EMA and not the FDA? There are lots of successful drug companies in Europe which did trials under EMA before taking their drugs to the US market no?

Looking at the ESPR issues I think DM and his team deserve some credit in advancing 208 into an affordable PIII trial situation. RVX has managed to avoid doing a very expensive CVD outcomes trial. RVX has navigated its way through the EMA regulatory framework extremely well by the looks of things. This is no small achievement when you are trying to advance a new drug, at the cutting edge of science, which has a multi-modal MOA. Must be super difficult for lots of scientists/KOLs to get their heads around the fact that BET inhibition can do so many different things to your body’s biochemical pathways.

I think the Yale presentation really showcased all the due diligence and painstakingly methodical research they have been doing over the last 2 years; and building support with KOLs; and talking about pharma economic models with payers. RVX is now in a situation where it has the potential remit to do ODD trials for indications which weren’t even in the picture 12 months ago when the MOA was less well understood (I noted with interest that sales of ALXN’s Soliris are mostly outside the US). If there was a silver lining to the Assure failure then perhaps it is that it forced RVX to do all this painstaking analysis on the multi-modal MOA.

tundup