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Re: IB2011 post# 4849

Monday, 08/08/2011 4:25:44 PM

Monday, August 08, 2011 4:25:44 PM

Post# of 20689

....MNTA can use some of its cash horde to fund an M-Copax clinical trial.


From Dew's post -

This has been asked and answered on several occasions. The simple and direct answer is that the FDA accepted NVS/MNTA’s Copaxone application for review under the 505j (ANDA) regulatory pathway.

....the whole point of the 505j regulatory pathway is to allow generic drugs to come to market without clinical trials....