News Focus
News Focus
icon url

BIOChecker4

11/23/25 9:44 AM

#509497 RE: georgejjl #509470

It is misleading to say that the only new trial that will be needed will be a phase 4. The truth is that we do not yet know what the EMA may require. In all likelihood, the EMA will require a large phase 3 trial. We will find out soon enough.