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Third Quarter Conference Calls, In Brief

Executive Summary

Novartis Prexige launch delay?: Novartis anticipates launch of COX-2 inhibitor Prexige (lumiracoxib/COX-189) could be delayed until 2004. "We have here left a range for the launch. It is too early to speculate what the scientific and regulatory environment will be 15 months from now," Clinical R&D Head James Shannon says. "It is possible that we will have a straight 12-month review, and we could get approval at the end of 2003, but we feel it is conservative and gives a better indication, a better guidance, that we place the launch somewhere in 2004." Novartis plans to submit an NDA by year-end; the ongoing TARGET study will not be required for approval (1"The Pink Sheet" Nov. 12, 2001, p. 32)...
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