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Alias Born 02/15/2011

Re: None

Friday, 11/10/2017 3:48:14 PM

Friday, November 10, 2017 3:48:14 PM

Post# of 12427
LXGTF Development Plan from the executive summary:
• Develop regulatory plan and meet with FDA to confirm
• Create test platform for algorithm development
• Establish scientific advisory board
• Create quality system
• Identify and sign contract with manufacturing partner
• Manufacture units
• Acute calibration study
• Clinical study comparing cFMD to uFMD (or
other standard) and show positive correlation
• Submit for FDA approval with calibration study data