Teva officials told the Journal that the company met with the FDA in October and raised questions about possible bias. It (TEVA) has said its application, which was filed two years before Momenta's, is stuck in bureaucratic limbo, and that it received delayed notice when the FDA changed the terms for evaluating the drugs.
Teva is complaining about terms/standards that were; evolving, adapting, being developed (take your pick), with the ultimate intent of defining rigorous standards and ensuring public safety by the FDA. They were not able to "hit the moving target" while Momenta was able to step up to the challenge (probably because they helped write the book on these standards).
I've said it before and I'll say it again: the FDA will fight this criticism (and lawsuits - Amphastar, Sanofi) by defending Momenta's superiority.
Hmmm, Teva's public squawking might also be a preemptive move to slow down mCopaxone as the FDA would probably want to ensure that mCopaxone approval is free and clear of any construed bias.
Teva is envisioning that they are about to have their lunch eaten...as a MNTA long, this is something I'm all for.
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