Dr. Tanzi Comments, page-29

I'm not sure how long it takes for Ema to respond.. Anyway it hasn't been submitted at the time of the annual report, who knows of it has since then

From annual report :
"The US Food and Drug Administration (FDA) currently has a partial clinical hold on PBT2 that limits the dose that can be administered in trials in the US. In response, we have submitted a strong technical and safety data package, incorporating our Phase 3 HD trial design in support of lifting the hold. Concurrently, we are creating a comprehensive non-clinical and clinical package of data on PBT2 for submission to selected European national authorities and the European Medicines Agency."

Note, the fda has 30 days to respond but they can just say "need more info" .. Which prana would have to spend time preparing again.. Hoping that arent sent down take home again but I'm curbing my enthusiasm until we get news


(but still can't help get excited at thought that there is a chance we can get an announcement about hold being lifted this week )