I was replying to your false claim to Dew that the FDA cannot give final approval for an ANDA for a drug that has valid patents listed in the Orange Book. In the case of Momenta, the DIstrict Court order will likely enjoin the FDA from a final approval until expiration of the patent, but it will be that order, and not the fact of a valid patent, that prevents final FDA approval. I'm not holding my breath, but until that order is issued, the FDA could approve. The consequence of such an approval would be no different than a tentative approval, because the Court will also almost surely enjoin Momenta from launching prior to the expiration of the patent.
This is all academic as I see no difference between final and tentative approval in these circumstances. The benefit of the approval will be launch if and when the patent expires or there is a successful appeal or settlement. GIven that TEVA has contended in three Citizen's petitions that the FDA should not approve without requiring a clinical trial, approval, whether tentative or not, is significant, at least to me.
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