Replies to post #64202 on 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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[DewDiligence]

MNTA – Craig Wheeler said this today on the first-to-file status for generic Copaxone (Sandoz/MNTA submitted the Copaxone ANDA on 12/27/07, the known date of the first ANDA submission from any company):

“Unless there was another company that was working over Christmas and submitted on the 27th, our chances of being the first to file are pretty good.”

The art of the understatement :- )