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pollyvonwog

12/10/10 3:45 PM

#110661 RE: DewDiligence #110659

So why go at it again? Seems a bit silly.
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zipjet

12/10/10 3:46 PM

#110662 RE: DewDiligence #110659

I find it a bit funny that TEVA files a third CP.

Since FDA has already addressed this and since they often like to answer the CP at the same time they approve the ANDA this sets up well for that.

ij
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mouton29

12/10/10 4:23 PM

#110668 RE: DewDiligence #110659

<<That’s right. Teva’s first Copaxone CP was rejected by the FDA because it was filed prematurely and Teva’s second CP (the one referenced in my previous post) was rejected by the FDA on the merits>>

The law of symmetry demands that the FDA approve generic Copaxone and reject this CP on the ground it is moot.