MNTA: "Given the regulatory timeline I discussed and the timing of the patent litigation, we do not expect an M-Enoxaparin approval and launch in 2008. [NVS previously said this on their own 2Q08 CC (#msg-30763224).] It's always difficult to predict the timing of any FDA approval action but with our partner Sandoz, we are planning for a 2009 approval and product launch."
Just a redundant clarification for new readers: "Approval" can occur at any time, but "launch" is considered to be facilitated after the 180-day exclusivity clock runs out (assumed to be in late Q1/early Q2 2009.) However, as has been mentioned, a deal could possibly be worked out whereby MNTA/Sandoz could launch before such 180-day expiration. The key remains "approval," which *may* occur in 2008. Hence, the phrase "approval and launch" is a catch-all.
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