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KTOV (MC $16 M) (Cash $17 M) US-NDA Submission for Big Drug this Quarter

another super hot and dirt cheap FDA play

KTOV (MC $16 M) (Cash $17 M) US-NDA Submission for their osteoarthritis pain and hypertension drug exptected this Quarter. This ultra low float stock will be one of the hottest and most underpriced FDA play i ever have seen in last 20 years in stock trading. KTOV has really more than 10 bagger potential the stock is trading at cash level and the valuation is ONLY $16 Million i cant believe it but please do your own dd and realize the brutal potential here .Im so in and GL


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...

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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An older article but nice one which shows the massive potential here

https://seekingalpha.com/article/3939596-kitov-pharmaceuticals-bull...

Conclusion

In my original article, I ballparked KTOV's valuation at $22.50 per share. That valuation assumed KTOV took KIT-302 to market on its own and therefore, included additional equity financings and a concomitant higher share count on which to base the per share price. It also assumed a weaker marketing capability and therefore, lower peak sales. In this article, I've estimated KTOV's valuation on the idea that it sells KIT-302 to a large pharmaceutical company and I've provided some comparables to ground this valuation. (Nonetheless, there are a lot of assumptions here, particularly the peak sales numbers and the DCF inputs.) The comparable valuation method gives a share price target range of $13 to $29 per share, which corroborates the initial $22.50 per share target. As a result, I continue to hold KTOV as one of my favorite longs, and am hoping for a big payoff within the next four years or so. Indeed, after performing this research, I think it's likely that one of the companies mentioned in the article will buy KTOV sooner rather than later - with Pfizer (Celebrex's developer) being my front-running candidate.

KTOV (Market Cap $20 M ) (Cash $11 M) FDA Decision in Q2 + Phase 3 Results this Q / Shares Out: 10.6 M = HUGE Upside Potential here

Kitov Phama (KTOV)

Market Cap $20 Miillion
Cash $11 Million
Price: 1.94

Shares Out 10.6 Million

Kitov Announces FDA Acceptance of NDA for KIT-302
https://www.baystreet.ca/articles/research_reports/lifesci/Kitov100...

KIT-302 is a Treatment for Hypertension and Osteoarthritis Pain.
KIT-302 is a fixed dose combination drug comprised of the nonsteroidal anti-inflammatory drug (NSAID)celecoxib, and the well-known antihypertensive agent, amlodipine besylate. Celecoxib monotherapy often leads to hypertension, which if uncontrolled, can increase the risk of heart attack and stroke. KIT-302 is designed to provide a solution for physicians who avoid prescribing NSAIDs for osteoarthritis pain due to their hypertensive side effects. There is currently no single drug for the treatment of pain and hypertension, so, if approved, KIT-302 could be a unique product in the multibillion-dollar osteoarthritis market.

Expected Upcoming Milestones

■Q4 2017 – Top-line results from Phase III kidney function trial.
■Q2 2018 – Expected FDA approval decision for KIT-302.

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