Thanks as my question was looking for an answer but you don't surely get to have a control group if these patients have no other options other than death - you can't expect some people to join the group if they know some will get " nothing". In fact the control group in this case is the time any of these test patients will live. However I could see the FDIC requesting a larger group! My guess is that G'tech will ask for a tentative approval for a limited use of the drug - if this was refused then I think we have a real problem at the FDIC - safety isn't surely an issue when the alternative is death!!!