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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.