While Novartis AG's oral treatment, Gilenya could gain market share during 2011, Teva could file a new drug application (NDA) with the FDA for its own oral treatment, Laquinimod, in the first half of the year.
How could they file NDA for Laquinimod in the first half of the year when the second phase 3 result won't be known until 3rd qtr 2011?
From Teva's own press release:
Laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA) in February 2009. The second phase III study, BRAVO is still ongoing with results anticipated in the third quarter of 2011. Regulatory submissions in the U.S. and the EU will then follow.
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