Of course they are working on approval, as this factors into the RA approval/commercialization process, hence the importance of having it in place long before most think its necessary. You can have the best frug/treatment in the world, but if you can up-scale and mass produce its worthless until the time comes where you can. Personally I think the approval process may have started awhile ago in the UK and they may be very close. Recent posturing and discussions by NWBO @ ASCO seem to point that way. We are one PR away from lighting the fuse. Some see it, some dont. I always try to stay ahead of other retail investors as by the time the pile-on happens, the real money has already been made. I would rather be early to the show, than late. Chasing a SP is never fun and something I seldom ever have to do. If this takes another 6-8 month I could care-less, I have time. Not many good tech stocks to be throwing cash at anyway. That ship sailed last year.