Replies to post #110662 on Biotech Values

[genisi]

I don't think it's funny unless you find giving the legal department more work to be funny. Seriously, I think Teva knows this CP will be rejected. The purpose seems to be discussing the five criteria from generic Lovenox approval with regard to Copaxone and also asking for an advisory committee.

[DewDiligence]

Teva submitted a fourth Citizen Petition opposing FDA approval of a generic version of Copaxone on 6/4/12:

http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-0555-0001 (click on first link)

The House version (but not the Senate version) of the PDUFA-renewal bill pending in Congress has language to thwart the filing of repetitive, abusive Citizen Petitions. Perhaps the timing of Teva’s fourth CP on the same subject is explained by trying to get it submitted before the pending PDUFA bill becomes law.

Background: Teva’s first Copaxone CP was submitted in Sep 2008 and was rejected by the FDA as premature; Teva’s second Copaxone CP was submitted in Dec 2009 and rejected by the FDA on its merits; Teva’s third Copaxone CP was submitted in Dec 2010 and was likewise rejected by the FDA on its merits.