Yes, IMO. MNTA’s generic version of 40mg Copaxone has an FDA decision (BsUFA) date during 2H16, and I expect FDA approval on the first review cycle because the 40mg product is essentially the same as MNTA’s generic version of 20mg Copaxone.
40mg Copaxone has about 80% of the combined 20mg/40mg US Copaxone market; FDA approval of the 40mg generic will make MNTA cash-flow positive again.
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