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DewDiligence

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Re: pollyvonwog post# 99536

Friday, 07/23/2010 6:47:22 PM

Friday, July 23, 2010 6:47:22 PM

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What's the earliest MNTA could attain Copaxone generic approval if the judge doesn't issue the summary judgment?

The FDA can grant tentative approval for NVS/MNTA’s Copaxone ANDA at any time.

The FDA can grant final approval for the ANDA, which is needed for product launch, upon the earlier of: i) Feb 2011 (when the 30-month Hatch-Waxman clock expires); or ii) an appellate court ruling holding that Teva’s US Copaxone patents are unenforceable.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
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