I agree getting the plant up to code is not a big stumbling block for Teva. But my read is that the FDA would not have wasted their time inspecting the facilities if they did not have a reasonable expectation of approving the drug to be manufactured there within a year. Do you have a different read on this? I'll freely admit I'm not experienced in this area.
And yes, MNTA shareholders must be getting nervous :)
I'm actually sleeping quite well at night as a MNTA long, which is surprising given all the doom and gloom surrounding MNTA these days. Even if we are to take the leap and assume that Teva's generic Lovenox will be approved by the FDA in the near-term, how can one be certain that its generic Lovenox will be approved and be deemed fully-substitutable? I think that's an important question that people seem to forget. Also, even if we are to assume the absolute worst-case scenario pans out and Teva's generic Lovenox is approved and deemed fully substitutable, let's not forget about the potential opportunity for MNTA with generic Copaxone. That very large opportunity is still very much a possibility and if MNTA does indeed get the authority to go ahead and market a generic Copaxone, MNTA doesn't have to worry about Teva as competition there (unless we're talking about Teva launching an authorized generic of Copaxone I suppose). Let's also not forget about the rest of MNTA's pipeline, namely the proprietary programs that are entirely separate and distinct from the generic programs. All told, I find all the doom and gloom a bit overblown. ; )
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