Biotech Values

[DewDiligence]

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.