Approval comes when the FDA is satisfied with efficacy , similarity and a number of other points. This could of came months ago if it met their guidelines. I believe the FDA does not care about patent expiration , they are not the patent office or a legal entity that should be concerned about such matters. That is what the courts are for. With that said I don't expect approval any time soon. With the major price drop over last couple months , a lot of people do not expect it either. But some times the world surprises. But I think that the May date will come and go with nothing. Momenta will still say they are in communication with the FDA in their next CC same as they have last 5 quarters or so..