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Entera Bio Inks Deal With FDA For Single Phase 3 Trial To Support NDA For EB613 For Osteoporosis

Entera Bio Inks Deal With FDA For Single Phase 3 Trial To Support NDA For EB613 For Osteoporosis

Entera Bio Ltd. (ENTX), a developer orally delivered peptides and therapeutic proteins, announced Thursday the successful conclusion of its Type C meeting and agreement from the U.S. Food and Drug Administration (FDA) that a single Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission of EB613 (oral hPTH (1-34), teriparatide tablets) under the 505(b)(2) regulatory pathway.
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