Replies to post #3403 on Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[Oceanfreedom]

It's coming anytime. From most recent pr:


"We have advanced according to plan in the clinical, chemistry, regulatory, and intellectual property areas of KIT-302's development," remarked Kitov's CEO, Isaac Israel. "We are on track to submit our NDA for KIT-302 anticipated for the end of 2016. We are committed to extending our pipeline of drugs with cutting edge technologies, and to continue securing the intellectual property rights over our proprietary assets in order to maximize value to our shareholders."

Ps. I also thought this hinted at acquisition coming: "We are committed to extending our pipeline of drugs with cutting edge technologies"

[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