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ghmm

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ghmm

Re: None

Wednesday, 12/12/2012 4:01:11 PM

Wednesday, December 12, 2012 4:01:11 PM

Post# of 252468
Question on sNDA vs NDA for 3x week Copaxone

On the Teva analyst day there was a question regarding that. Teva management indicated they did not think more data would be required to file (in the US at least) and were in dicussions with FDA as to whether it would be an sNDA or NDA. I have a question for anyone more knowledgeable in this things. If it is approved what would be the difference in how it is was filed (i.e. is it more preferable to go one route vs. the other?)
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