We are currently conducting ph I/II trials. Does this mean after this round of trials are completed (150k, 200k cells implanted) that we apply for ph III? Or, does it mean we received approval to run ph I and ph II in series, and ph II will start next? Thank you in advance for any responses.
Gary is hopping to go right into phase 3 trials from phase 1. They will of course need to get some very good results from a few of the phase 1 patients. Our advantage as you know is that the eye is self contained so they can easily confirm that there are no side effects and that the treatment is working, thereby giving the FDA confidence to let ACTC go right into phase 3 trials. Let's hope it works that whey.
So we do have to do a serial Ph I followed by Ph II unless we receive special permission from the FDA to jump to ph III. Ph I and ph II are not combined in to one.... Why do they call it a ph I/II study then? Is it only because both are approved at this time? Thank you for the reply and any future information.