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mufc7

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mufc7

Re: None

Wednesday, 01/17/2018 3:24:04 PM

Wednesday, January 17, 2018 3:24:04 PM

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Development Plan
• 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
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