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Tuesday, July 18, 2017 12:57:30 PM
Kitov Pharma (KTOV)
Market Cap: $16 Million
Cash $17 Million
Price: $1.44
Shares Out: 10.6 Million
Kitov Updates on KIT-302 New Drug Application http://kitovpharma.investorroom.com/news-releases?item=50
Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.
Presentation June 2017
http://kitovpharma.investorroom.com/download/KitovPresentation+June+2017+FINAL.pdf
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
https://baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdf
Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
Kitov Received a $2 Million Filing Waiver from FDA http://kitovpharma.investorroom.com/news-releases?item=46
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
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