That is correct, except that in certain situations, when the drug (or in this case the technology) is a breakthrough (it is called breakthrough status by the FDA) or even "fast track" (Not as vital) It can take less than a year for a decision with the former. This has been done recently with some Hep C drugs as in the case of a Gilead drug called Solvaldi and this designation have also been given to other new hep c drugs in the pipeline which are due for an FDA decision shortly. I believe that the "fast track" designation only means given priority attention and does mean a decreased time for approval (or non-approval for that matter).