Biotech Values

[DewDiligence]

MNTA first-to-file status on generic Copaxone:

>They are not sure if they are "first to file." Yet. However, it seems obvious that they are.<

It just became more obvious. The FDA’s list of Paragraph-IV challenges shows 27-Dec-2007 as the date of the ANDA submission for Copaxone, and we know that this was the date Sandoz/MNTA submitted:

http://www.fda.gov/cder/ogd/ppiv.htm

Unless another company submitted a Copaxone ANDA on the exact same day (the probability of this is too small to try to quantify), Sandoz/MNTA are indeed the first to file.




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