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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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