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0.000327410185433095 0.00046373188082269 0.000327410185433095 0.00750066970265197 -0.00690537845640978 -0.00467303628300144 -0.00607197071167075 -0.00800666726195791
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FDA agrees to single phase 3 trial by Entera for bone disorder drug EB613 to support approval [Seeking Alpha]

Eli Lilly and Company (LLY) 
Last eli lilly and company earnings: 4/23 06:25 am Check Earnings Report
US:NYSE Investor Relations: investor.lilly.com
Company Research Source: Seeking Alpha
FDA agrees to single phase 3 trial by Entera for bone disorder drug EB613 to support approvalOct. 06, 2022 8:35 AM ETEntera Bio Ltd. (ENTX)LLYBy:RavikashSA News Editor1 CommentSDI Productions/E+ via Getty ImagesEntera Bio (NASDAQ:saidInthemeeting, the FDA also agreed that change in Total Hip Bone Mineral Density (BMD) could serve as the main goal of the 2-year study of EB613 [oral formulation of PTH (1-34, teriparatide)], which is expected to enroll 400 patients in total, the company said in an Oct. 6 press release.Entera added that FDA agreed to the proposed enrollment of post-menopausal women with osteoporosis based on a BMD T-score of â?¤-2.5 to -3.0 and no major fracture history. This patient population was similar with that studied during the company phase 2, 6-month dose ranging study which met all main and secondary goals.The company intends to submit relative PK data comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo Show less Read more
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