Koo,

I'm assuming that this means that this is the European Medicines Agency (EMA;http://www.ema.europa.eu/ema/). Perhaps a future RVX blog could focus on how FDA approval may differ from EMA and approval in other countries.

The "confirmation for our Phase 3 clinical plan has officially been received" means to me that with the European approval, that the European portion of sites for BETonMACE are now approved. But keep in mind BETonMACE is proposing to include sites in non-European countries as well Probably after the June 30th special meeting and/or the official closing of the Hepalink deal (in July I think) then the Asian sites can be "confirmed." And hopefully discussion with FDA for inclusion of US sites is still a possibility.