Biotech Values

[DewDiligence]

Teva’s low-volume Copaxone is not Copaxone—it’s a distinct drug that required Teva to submit an NDA under the 505b2 pathway.

I’m surprised that you were hoodwinked by the spin in Teva’s PR that posits a linkage between Teva’s low-volume Copaxone NDA and NVS/MNTA’s Copaxone ANDA. In fact, no such linkage exists because these are two different drugs.

That the FDA rejected Teva’s NDA for low-volume Copaxone was fully expected by those who have done a modicum of DD on this matter. The reason rejection was expected has nothing to do with Copaxone per se; rather, rejection was expected because Teva’s data package, consisting of a single open-label trial, was pathetically weak.

Please see #msg-50939364 and #msg-51123550 for additional background info.