MNTA: How long will we have to wait before FDA rules on MNTA's generic Lovenox?
ANDA’s do not have PDUFA dates, so no one knows when the FDA will act.
As an aside, if ANDA’s did have PDUFA dates and hence investors knew when the FDA was going to act on the Lovenox ANDA, dimwitted biotech speculators would probably be pumping MNTA now the way they’re pumping such companies as HEB. Corollary: because ANDA’s do not have PDUFA dates, you can buy MNTA a lot more cheaply than you could if ANDA’s did have PDUFA dates.