Biotech Values

[DewDiligence]

MNTA 2009-2010 Possible/Probable News Flow

[Updated for presentation of M118 data at TCT conference on Sep 24.]


24-Sep-2009: Presentation of M118 data at TCT conference.

2H09: 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.

2H09: Partnership deal for M118.

2H09 (following partnership deal): Start phase-2b trial(s) for M118.

2009-2010: IND filing for M402, MNTA’s proprietary heparin-based cancer drug.

2009-2010: Possible announcements of new FoB partnerships 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.