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DewDiligence

08/05/13 12:59 PM

#10814 RE: alertmeipp #10813

To answer, one needs to handicap a few issues including, but not limited to, the following:

1) Does FDA award six months of first-filer exclusivity to MNTA? The normal Hatch-Waxman period during which FDA can make such an award (30 months from first ANDA submission) has long since expired, but FDA has the discretion to make the award anyhow if warranted by unusual circumstances.

2) Does FDA approve Teva’s thrice-weekly Copaxone and, if so, when?

3) If FDA approves thrice-weekly Copaxone, does Teva continue to detail regular Copaxone as stated on last week’s CC? (If so, this is bullish for MNTA.)

4) Does Teva license another company (or one of its own subsidiaries) to launch a Copaxone authorized generic?

5) What market share of the US multiple sclerosis market will Copaxone have in May 2014?