"The FDA has approved the Phase III clinical trial design for KIT-302, in a Special Protocol Assessment, in accordance with the shortened regulatory pathway, Section 505(b)(2)" http://www.in-pharmatechnologist.com/Regulatory-Safety/Kitov-saves-time-and-money?utm_source=RSS_text_news&utm_medium=RSS_feed&utm_campaign=RSS_Text_News KTOV plans a marketing approval in 2017.