Taken from recent presentation p8
.Pivotal Phase III trial completion estimated by mid-2014
•FDA submission expected 2H 2014 utilizing 505(b)(2) pathway
•Approval expected 2015 (US), 2016 (EU)
This sounds extremely positive - they have even dropped the word 'potential' and are now running with 'expected'.
Just cant understand why there doesn't seem to be any excitement over this company
Ann: Investor Presentation , page-19
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