Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[ash111]

You asked about The final and complete analyses, including the clinical study report...so "According to FDA requirements, a similar PK bioequivalence study for the KIT-302 product, containing a lower dosage (2.5 mg) of amlodipine will be conducted by the end of this year. The FDA has indicated that KIT-302's final approval will not be dependent on this study's results". https://www.firstwordpharma.com/node/1382154?tsid=17

Also on June 24, 2016 kitov announced newly available data from its successfully completed Phase III study of KIT-302 : http://www.newswest9.com/story/32300319/kitov-reports-new-data-demonstrating-kit-302-has-beneficial-effects-on-kidney-function

And on June 28, 2016,Kitov's Lead Drug KIT-302 Achieves Manufacturing Milestone Ahead of Planned NDA Filing with U.S. FDA..."has successfully completed an initial stability study for its lead drug candidate KIT-302".
http://www.prnewswire.com/news-releases/kitovs-lead-drug-kit-302-achieves-manufacturing-milestone-ahead-of-planned-nda-filing-with-us-fda-300291276.html