MNTA- Dew, I'm sure you've addressed this question before, but I took a position in MNTA this week & I'm trying to get a better grasp of some issues.
M-Enoxaparin, its my understanding that MNTA produces an exact replica of the molecule so it doesn't make sense to conduct clinical trials for the immunogenicity issue. Their technology puts them ahead of TEVA & other generic manufactures who have also filed ANDA's for M-Enoxaparin.
Is the argument against Teva, etc's approval that their generic versions are different molecules?
What percentage chance do you give for MNTA being the sole generic manufacturer approved?
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