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Oral teriparatide tablet (EB613) gets FDA nod for Phase 3 trial

Osteoporosis & Bone Health | Last Active: Jun 30 2:13pm | Replies (28)

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@mayblin

Here is the link for press release;
https://www.biospace.com/press-releases/entera-bio-receives-positive-fda-feedback-on-12-month-registrational-phase-3-study-for-eb613-the-first-oral-anabolic-tablet-in-development-for-postmenopausal-women-with-osteoporosis

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Replies to "Here is the link for press release; https://www.biospace.com/press-releases/entera-bio-receives-positive-fda-feedback-on-12-month-registrational-phase-3-study-for-eb613-the-first-oral-anabolic-tablet-in-development-for-postmenopausal-women-with-osteoporosis"

tillymack | @tillymack | Jun 24 10:37am

@mayblin Very exciting development!
I read: Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028.
Do you know how to interpret that statement in terms of when this might be available to the general public?

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