We have completed enrollment in the ongoing Phase 2 clinical trial of EB613 in Israel and filed an IND with the FDA for EB613. Based on feedback we received from the FDA in 2018, we plan to pursue approval of EB613 utilizing the 505(b)(2) regulatory pathway, as permitted under the Federal Food, Drug and Cosmetic Act. Our intent is to seek additional FDA guidance on the design and parameters of a Phase 3 clinical trial as part of a post Phase 2 meeting in the second half of 2020.


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