Does the FDA's acceptance of the application as a 505(j) shed any light on how they view MNTA's technology? There are analysts out defending TEVA stating that generic Copaxone will likely fall under the new biologics legislation, implying clinical work will be necessary.
I think these analysts are underappreciating the possibility that MNTA's technology may give them a unique advantage that will avoid the need for clinical work.
Of course only time will tell but M-enoxoparin approval would be a giant step towards generic Copaxone approval.
Market Data 
Markets 
AI
