Replies to post #104114 on Biotech Values

[DewDiligence]

But isn't the low-volume Copaxone considered a new drug?

Yes.

So the approval process is much more difficult.

More difficult than what? Surely, the FDA review of Teva’s low-volume Copaxone, which differs from branded Copaxone only in the concentration of active ingredient per ml, will be very much simpler than the FDA review of NVS/MNTA’s Copaxone ANDA.