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Cash runway updated into October 2018
Recent Pre-NDA Meeting Provided Guidance on Female Only NDA Filing Strategy and Post-Approval Safety Study
Call Scheduled for October 31st at 9am ET
505(b)(2) NDA on track for FDA submission in Q1 2018
Data expected in Q4 2017 followed by a 505(b)(2) NDA submission in late 2017/early 2018
Expected to be final clinical trial prior to 505(b)(2) NDA submission
Company on track for late 2017/early 2018 submission
Data Demonstrate Gimoti Significantly Improves Symptoms in Women with Moderate to Severe Diabetic Gastroparesis
Company reaffirms NDA submission by year end 2017
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