In an older call (Q4 2006) they also said they could petition the FDA to eliminate the 180 day waiting period based on futility of their (Teva/amphastar) application. But I am guessing this would take the better part of the 180 days to do. It sounded like IF they (Momementa) were approved that some sort of deal would be negotiated.
I was going back over an older call and Momementa said that Teva's application in Canada was approved but each province needed to put it on formulary which never happened and the application was delisted (rejected). They (Momementa) believed it was because of requirement to for trials. Has anyone ever heard anything about this from another source (like Teva)?