I have never seen a management team so confident, without hyperbole, as to the quality of their product. I don't think there is any question that MNTA's management team does not believe, but knows, that their version of copaxone is as identical to the innovator drug as enoxaparin is to its innovator drug. Unfortunately, they have to wade through the regulatory thicket despite this fact.
I do agree that if MNTA is conducting a month or two long bioequivalence study, that they are near the end of the process. It is not something that they would do early on in the process.
I put the odds heavily into 2012, only because of FDA backlog. Were this a less overburdened and efficient agency, I would think the drug is ripe for a 2011 decision. I give it 6-12 months after the period of time that management believes the decision could be imminent. Similar to what happened with enoxaparin.
Yes, it does appear unlikely that tenoxaparin will be approved any time soon, but here is a scenario no one else has broached, what if the FDA approves both mcopaxone and tlovenox on the same day! I think MNTA share price skyrockets once the market actually takes into account what just happened with copaxone, and Teva crashes. Then again, that scenario does seem somewaht ridiculous givne Teva's current enoxaparin posture. It just seems incongruent for the FDA to approve something that is clearly not the same, as MNTA has proven the "same" within the biological variability is indeed possible. A generic is suppose to be medicinally equivalent after all, and not just good enough. Which is s standard that the FDA appears to be holding firm on, at least with enoxaparin.
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