They will be worldwide no matter what the FDA has to say, They proved to themselves and the medical community that it works. Dont be confused by the corruption of wallstreet. The last 8 years with the Bush administration proves to be a time of wide range corruption that has put our entire world in jeopardy. Eyes are wide open for mis-doings, so my suggestion is, either buy and hold....or daytrade. but shorting this at any point can be devistating if any news of partnership or buyout, or any other positive study results....dont forget they do have other ongoing trials.