Teva's latest trials are one small and few months long trial : http://clinicaltrials.gov/ct2/show/NCT00947752?term=teva+song&rank=1 and one large and long: http://clinicaltrials.gov/ct2/show/NCT01067521?term=teva+gala&rank=1 What will the FDA ask for? I'm guessing something in between - few hundred patients and couple of years long.