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Re: genisi post# 150407

Thursday, 10/11/2012 7:55:30 AM

Thursday, October 11, 2012 7:55:30 AM

Post# of 252254

Assuming thrice-weekly Copaxone entry in early 2014…

That may be optimistic. Before reviewing the NDA, the FDA may want to see the results of GALA’s open-label safety extension, which is slated to run until May 2014 (http://clinicaltrials.gov/ct2/show/NCT01067521 ). If so, market entry will likely be delayed until mid 2015.

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