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DRG1025

09/15/16 2:42 PM

#45042 RE: Flenderson #45041

Isn't the design freeze and CE Mark more essential than FDA approval at this stage? FDA approval simply opens the door for us to operate/sell within the United States. So what's keeping us from getting to design freeze then CE Mark and at that point test the markets outside the U.S. and actually bring in revenue? Getting to design freeze and CE Mark doesn't require 65 million does it?