MNTA 2009-2010 Possible/Probable News Flow
[Removed entry for reporting of M118 data—the data are already out.]
2009: FDA action on Lovenox ANDA. (ANDA’s do not have formal timelines, and hence an FDA decision could come at any time.) If approved, generic Lovenox can be launched immediately because all patent-related issues have been resolved.
1H10: Partnership deal for M118 followed by start of phase-2b trial(s). (Based on the latest financing transaction, I’ve changed this entry from 2H09 to 1H1; it could still occur in 2009, of course, but I now think 1H10 is more likely.)
(Timing highly uncertain): IND filing for M402, MNTA’s proprietary heparin-based cancer drug.
(Timing highly uncertain): New FoB partnership(s) and/or progress on existing FoB partnership with NVS.
2010-2011: FDA action on Copaxone ANDA. Although the FDA is barred from granting final approval of the ANDA before the statutory 30-month stay expires in Feb 2011, the FDA is allowed to take other actions during this period including tentative approval, non-approval, or a request for more information.
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