At any time: FDA decision on the Lovenox ANDA. ANDA’s do not have formal timelines, so no one outside the FDA knows when a decision is coming. What we do know is that the FDA has inspected the physical facilities in the supply chain and MNTA/NVS believe they have given the FDA everything the FDA needs to approve the ANDA. If approved, generic Lovenox can be launched immediately because all patent-related issues have been resolved.
Copaxone
20-Jan-2010: Markman pre-trial hearing in the Teva lawsuit against MNTA/NVS. This is the point in the litigation where the court irons out the meaning of the relevant patent claims.
Feb 2011: Expiration of 30-month stay on FDA approval of the Copaxone ANDA. Unless there’s a final non-appealable judgment in the patent case before this date (possible but unlikely, IMO), Feb 2011 is the soonest that MNTA/NVS could launch their generic. (Although the FDA could conceivably provide feedback on the Copaxone ANDA before Feb 2011, MNTA probably wouldn’t disclose this unless the feedback was tantamount to a rejection.)
M118
1H10: M118 partnership deal followed by start of one or more phase-2b trials. (Phase-2b trials in ACS are sufficiently large and expensive that I can’t see MNTA running one on its own dime: #msg-44370052.)
Other
Timing unknown: IND filing for M402, MNTA’s proprietary heparin-based cancer drug.
Timing unknown: FoB partnership. (The likelihood and timing of this depend greatly on what the US Congress does with enabling FoB legislation.)
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