We intend to pursue approval of EB613 utilizing the alternative Section 505(b)(2) pathway permitted under the Federal Food, Drug and Cosmetic Act. Our intent is to seek FDA guidance as part of a Pre-IND meeting in the second half of 2018. Based on the response of the FDA, we intend to conduct a dose ranging Phase 2a study in approximately 150 osteoporosis patients. Following analysis of this data, we will design and execute pivotal trial(s) in osteoporosis patients guided by the feedback of the FDA.


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