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That covers: Fasting glucose (basal insulin) Post-meal glucose (GLP-1) Weight loss (GLP-1) Cardiovascular protection (GLP-1) The COMBINE Phase 3a trials have already shown superior HbA1c reduction with a lower insulin dose and non-inferior control vs

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The Prescription Drug User Fee Act typically calls for a period of 10 months for the FDA to review such applications, although drugs that are deemed a priority have a review period of six months.