The thing/difference with Rexulti and Cariprazine is that it has to go through the 3 phases of trials before approval/marketing in Europe. Lumateperone has NO development-status in the EU whatsoever. The company that develops this drug purely develops it for the US-market only.
I’m guessing if this will be a blockbuster in the US, they also want to market it in the EU afterwards. However, I’m trying to find an answer on how many years of “delay” we can expect if that’s the case. And I’m unsure if it will be “only” 3 years or many(!) more.
Just like Rexulti and Cariprazine, take MIN-101 and ALKS-5461 for example, both drugs which are respectively also in phase III and phase II in Europe. If they get approval too, we can expect a delay of 3 years with the US marketing. However, with Lumateperone, it’s a whole different story because there’s no development status for the EU at all!