What's the earliest MNTA could attain Copaxone generic approval if the judge doesn't issue the summary judgment?
The FDA can grant tentative approval for NVS/MNTA’s Copaxone ANDA at any time.
The FDA can grant final approval for the ANDA, which is needed for product launch, upon the earlier of: i) Feb 2011 (when the 30-month Hatch-Waxman clock expires); or ii) an appellate court ruling holding that Teva’s US Copaxone patents are unenforceable.
“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.