A limited indication only applies when side-effects affect a sub-group of patients. There is no big side-effect here, only a difficulty in interpreting the images from MRI relying on different technologies. I dont work with MRIs but anyone here who does will confirm this. The FDA should interpret the data as reflecting the different state of the MRI technology available; there is more than one standard, that's it. There is no reason for EPIX not to get approval and get back to 25 in a few months, none.
MRA of the abdominal vessles - or MRA of the renal arteries. The pivotal studies in this indication are quite unequivocal. Then, they may ask to do a comparative trial MS-325 in an MRA indication (or multiple MRA indication) versus current 0.5M standard. BUT, what's strange in all of this is that the FDA had given them approval of their plans many years ago, stating their current trial design was okay - but, they've seem to have changed their minds. I think there will be some pressures on the FDA to get their act together and approve this agent.