Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

From the FDA’s legal brief:

“Teva’s request that this Court decide whether an abbreviated new drug application (“ANDA”) may be approved in the first instance without first meeting Teva’s additional “conditions” for approval – conditions above and beyond what Congress has set forth in the [Hatch-Waxman] statute – is absolutely unprecedented, extrastatutory, and extrajudicial” [emphasis added].

Based on the above, I think it’s safe to say that the FDA is highly unlikely to require safety & efficacy trials for Copaxone ANDA filers, as some investors and analysts (astonishingly) still believe.