Yes, I get all that. However, IMO it goes to credibility; their attempt, once again, to try and throw a fast one past the FDA in lieu of actually doing the heavy lifting. From there, it seems to me that it should raise the question in any observers mind as to how much of the lifting they can actually do. At this point, two hard sliders notwithstanding... Strike Two.
TEVA - I can't understand how the FDA's statement on low volume Copaxone won't impact MNTA's generic approval.
"The FDA noted that the 0.5mL formulation contained the same active ingredient as the currently marketed Copaxone®, but that because the mechanism of action of Copaxone® is not fully understood, even a formulation change could impact clinical outcomes."
Wouldn't MNTA's formulation be considered a change even if contained the same active ingredient? Count me into the hoodwinked group.
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