Ann: Preliminary Final Report-PBT.AX, page-9

Of course FDA can block PBT2 to get to the market. That's what they have effectively done and what continues. They are doing their job in protecting the public until they are provided with reasonable proof of safety and efficacy before allowing it to get to market.

Assuming that other drug regulators (Europe for a start) will suddenly put an incompletely proven therapeutic on the market is really jumping to conclusions. The Europeans, like the US FDA, are professional scientists who will not side-step protocol to allow selling a compound that has not yet been ruled out as ineffective or possibly worse in its value to the public.

A long road continues to lie ahead IMHO. The information just now provided in the annual report is already two months old. There is a possibility that since the end of the fiscal year that something positive may have happened, such as actual submission of the data package et al to the FDA. That is the prime step that has delayed this long inactive period from coming to an end. If the FDA has received Prana's data and come to a positive conclusion, that will be the first hope that the EMA's receipt of Prana's data will also lead to their approval of an application to begin their investigation of PBT2. Then the waiting will continue.