Bone Medical shares results of meeting with FDA

By Lisa Kerner

Erie, Pa., Jan. 10 - Bone Medical Ltd. said that it will seek application under 505(B)2 for its oral formulation of salmon calcitonin (Capsitonin) after a positive pre-investigational new drug meeting with the U.S. Food and Drug Administration in November.

Bone Medical is clear to pursue its dose-ranging study followed by a six-month study of nasal marketed forms of salmon calcitonin for the treatment of osteoporosis. The primary endpoints for the study are bone markers for the dose ranging and pivotal studies with supporting secondary tests over the study period, according to the company.

Bone Medical, with headquarters in Bentley, Australia, is a biopharmaceutical company developing products to treat bone disease, including osteoporosis and arthritis.

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