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Basal Insulin, Bolus Insulin, DPP-IVi, Dual/triple agonist, GLP-1RA, Glucagon, Glucose Monitoring, Insulin Delivery, SGLT2i

REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 '19 Earnings Update

Here is a brief preview of this blast: Lilly hosted its Q1 '19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for "technical reasons," and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 '19 regulatory events in diabetes.