MNTA: Perhaps the FDA has not completed their review of each respective application for Teva/Amphastar. Regardless, immunogenicity will be a concern for both of those companies. MNTA received a "not approvable" letter because the FDA didn't want (apparently) to reject the app outright; additionally, an "approvable letter" mechanism isn't in place for ANDA's.
I probably misspoke. I should have said submit the immunogenicity data not refile.
On the competition, it's actually not material to teva stock so they dont need to disclose anything and amphastar is private, I bet they weren't happy when wpi publicly discussed it.
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