Unlike Lovenox, Copaxone does not have any “junk” that needs to be characterized (#msg-56267201), which makes Copaxone an easier task for MNTA to replicate, all told, than Lovenox was.
The FDA’s published guidance for what is required for approval of generic Copaxone will probably end up being taken from MNTA’s application, as was the case with Lovenox.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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