Teva reports results on the thrice-weekly low volume Copaxone trial at the end of this year. Assuming the results are positive will TEVA file an NDA for this new formulation or is another approval pathway available?
I don't see why TEVA needs to wait for the extension study to complete prior to filing for approval. Couldn't they file & then submit the extension study data as an addendum? I'm just trying to figure out if TEVA could get the low-volume formulation approved prior to the patent expirations & how it impacts generics entering the market.
TEVA/MNTA—In scanning some old posts, I came across yet another instance of misdirection by Teva’s Bill Marth (who is no longer with the company). Marth said as recently as late 2011 that Teva was still developing the “low volume” formulation of Copaxone: #msg-67094037. We know now that this program is dead, and it was probably dead even then.
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