Ann: Preliminary Final Report-PBT.AX, page-7

"Separately, creation of a comprehensive non-clinical and clinical package of data on PBT2 for submission to selected European national authorities and the European Medicines Agency (EMA) is underway".

So FDA cannot block PBT2 to get to the market. But of course it has taken lot of time to "create" the package and it looks it is still not ready. At least Shoulson poster and Tanzi's talk in Toronto will be added to the package with perhaps some new toxicological info and else. IMO the target is to get somewhere PBT2 to the market, not only to start new Ph3 study under the control of FDA. Unfortunately we do not know why there is this delay, but IMO there is some very good reason for it. But now we know that there will be several other authorities than FDA considering if PBT2 is ready to the markets.