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Post by bernstein on Jul 18, 2017 17:17:04 GMT
Another very hot and heavily undervalued FDA Gem ... 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 .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 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 kitovpharma.investorroom.com/download/KitovPresentation+June+2017+FINAL.pdfKIT-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 baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdfKitov 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 kitovpharma.investorroom.com/news-releases?item=46Kitov 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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Post by JHam on Jul 19, 2017 6:44:22 GMT
Another interesting find. I'll took a closer look later. Thanks for bringing it to our attention.
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Post by JHam on Jul 20, 2017 1:59:40 GMT
The science certainly looks compelling and the trial results are better than the standard of care. Plus it tackles two indications at once. The cash/market cap ratio is delicious and the o/s is really low. All things I like.
My only concern is, why is the price so low? They had great trial results, are about to file an NDA for which they will almost certainly get approved, have a SPA set up, and had the $2M NDA submission waived by the FDA. Is there something I am missing? Is it just that the market is late in discovering this one? Because NASDAQ is their secondary index? Do you know the reason for the massive sell off last fall? Capital raise/dilution?
It's an intriguing stock. May open a small position tomorrow.
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Post by JHam on Jul 20, 2017 9:52:18 GMT
I don't like this headline: Kitov Pharma CEO arrested and released, misleading study results suspected; shares down 26% premarketFeb. 7, 2017 9:26 AM ET|About: Kitov Pharmaceuticals ... (KTOV)|By: Douglas W. House, SA News Editor Kitov Pharmaceuticals (NASDAQ:KTOV) slumps 26% premarket on increased volume in response to the news that CEO Isaac Israel was arrested then released on bail in Israel. Apparently, the Israel Securities Authority suspects the company of publishing misleading information regarding findings from an independent committee appointed to review clinical trial results of one of its drug candidates. seekingalpha.com/news/3241116-kitov-pharma-ceo-arrested-released-misleading-study-results-suspected-shares-26-percentAnymore info on this? It looks as though it is still not resolved.
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Post by JHam on Jul 20, 2017 10:11:03 GMT
Here is the latest update from the company in a May 1st 6-K filing: www.sec.gov/Archives/edgar/data/1614744/000121390017004420/f6k050117_kitovpharma.htm On February 7, 2017, the Kitov Pharmaceuticals Holdings Ltd. (the “Company” or the “Registrant”) announced that it is currently being investigated by the Israeli Securities Authority (the “ISA” and the “Investigation,” or “ISA Investigation” respectively). The Company has not yet been advised by the ISA of the full scope and focus of the Investigation. However, the Company has had discussions with the ISA regarding the Investigation, and is now able to provide additional information to the Company’s investors and other stakeholders, with regard to the nature of the ISA’s concerns with respect to the Company. Based on these discussions with the ISA, the Company now understands that the Investigation with respect to the Company relates to the Data Monitoring Committee (“DMC”) that was appointed in connection with the Company’s Phase III clinical trial of KIT-302. In connection with the clinical trial, the Company appointed an independent statistician and an orthopedist to serve as the Company’s DMC in order to review the preliminary results of the initial patient group, with respect to determining if it would be necessary to increase the number of patients to be enrolled in the clinical trial in order to demonstrate statistical validity required to meet the primary endpoint of the clinical trial. This DMC’s responsibilities and reporting procedures were detailed in a document that was distributed to all the team members involved in the clinical trial, including the members of the DMC (the “Procedure”). According to this Procedure, a group of external independent statisticians was to receive the preliminary clinical trial results and analyze the standard deviations. The Procedure provided that the independent statisticians would send the analyzed standard deviations to both of the DMC members, who would then review the analysis, and determine whether or not the primary efficacy endpoint was met (i.e. they were to look at the statistician's printout and see if the lower limit of the 95% confidence interval for the KIT-302 drug exceed 50% of the value for amlodipine). The Company understands that the ISA is investigating the circumstances surrounding the actual dissemination of the statistical analysis to the members of the DMC, and whether or not this led to any misleading disclosures in any of the Company’s public filings. The Company believes that the ISA’s concerns with respect to the DMC are misguided and not consistent with industry accepted U.S. Food and Drug Administration (“FDA”) regulatory requirements, nor with the procedures for the conduct of clinical trials for the purposes of New Drug Application submissions to the FDA. In addition, the Company strongly disputes the legal ramifications of any possible concerns of the ISA with respect to the Company’s disclosures in these matters. The Company firmly believes that, (i) information relating to the circumstances surrounding the actual dissemination of the statistical analysis to the members of this DMC is not material; and, (ii) that such information was not material at the time of the Company’s announcement of the final clinical trial results. This matter had no impact whatsoever on the validity of the statistical analysis of the KIT-302 Phase III clinical trial data, which met its primary efficacy endpoint with statistical significance. Furthermore, the Company believes that the ISA is not the regulatory body authorized to evaluate the materiality of events and the completeness of public disclosures made by the Company in compliance with United States federal securities laws. The process actually undertaken by the Company in connection with such clinical trial results, fully complied with the requirements of the FDA, and the Medicines and Healthcare products Regulatory Agency (“MHRA”) and the human ethics committee agreed-to protocol for the Phase III clinical trial of KIT-302 (“Clinical Trial Protocol”). Some clinical studies, mostly in certain types of Phase III clinical trial studies where it is required under the applicable clinical trial protocol, are overseen by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or committee. This group recommends whether or not a trial may move forward at designated check points based on access to certain data from the study. The clinical study sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate. According to the KIT-302 Phase III Clinical Trial Protocol approved by the above-mentioned regulatory authorities, no data monitoring committee or data safety monitoring board or committee was required at all, and the committee named “DMC” by the Company, had no authority or power to modify or otherwise alter the conduct of the clinical trial, and was not tasked with usual data safety monitoring board or committee responsibilities related to a clinical trial. In accordance with the Clinical Trial Protocol, which had been approved by the FDA, the decision as to whether or not to add additional patients, or to stop patient enrollment, was based solely upon the statistical analysis of the preliminary data performed by an independent statistician (who was also a member of our “DMC”). The statistical analysis of the preliminary data collected in the Phase III clinical trial definitively showed that the study met the pre-specified criteria the FDA required for stopping patient enrollment and completing the final statistical analyses. The statistical analyses of the efficacy data collected in the Phase III clinical trial of KIT-302 resulted in a p-value of less than 0.001, clearly demonstrating that the Phase III clinical trial met its primary efficacy endpoint with statistical significance (any p-value less than 0.05 would have been adequate by statistical standards for proving efficacy).
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Post by bernstein on Jul 20, 2017 13:55:52 GMT
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Post by JHam on Jul 20, 2017 14:19:07 GMT
I also just opened a teeny position at $1.57. If the data results weren't embellished by the DMC, then I think this gets approved quickly. I agree that this is what has likely bogged down the pps over the past several months (plus the raise). I would feel less confident if we had to rely only on management's word about the investigation being a non-event. However, the FDA, imo, wouldn't wave the $2M NDFA submission fee if they thought this was an issue.
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Post by JHam on Jul 21, 2017 2:00:56 GMT
Wow. Huge run up today. Already up 14% Thanks Bernstein. If it dips at all tomorrow I'll likely beef up my position. I don't know if the recent run up is due to people anticipating the NDA submission, insiders responding to the investsigation being dropped, or what, but this seems to have some legs. At the very least this is still a good value play. Good luck to us!
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Post by JHam on Jul 21, 2017 13:39:04 GMT
Holy mackerel! Blasting right out of the gate. Up to $2.42 (35%). Didn't have a chance to grab more.
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Post by JHam on Jul 21, 2017 15:34:32 GMT
Well that was fun. Back down to earth. Classic pump and dump. I forgot how easy these low o/s stocks can jump. Glad that it is back below $2 though since I would like to add more in the next few days. Today was just a small taste of what can happen though when good news hits.
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Post by JHam on Jul 24, 2017 14:18:23 GMT
Figured this was going to happen today. I'll be a buyer in the $1.60s.
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Post by JHam on Jul 28, 2017 12:21:05 GMT
I've been waiting for this to drop a bit so that I could add more, but it seems to have formed a bottom around $2 now. We'll know if that new base is for real or today if there is no PR today for the NDA go ahead.
I am up 45% so I'm not complaining, but would like to add some more if the price is right.
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Post by bernstein on Jul 31, 2017 19:54:39 GMT
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Post by JHam on Aug 1, 2017 1:19:01 GMT
Very good. Why did they wait until after hours to announce this?
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Post by JHam on Aug 17, 2017 7:50:46 GMT
Q2 plus update from management: www.prnewswire.com/news-releases/kitov-pharmaceuticals-provides-corporate-update-and-reports-first-half-2017-financial-results-300505649.html" We are pleased with the significant progress we have achieved during the recent months. Thanks to the intensive, dedicated and professional work of our staff, investigators and CROs, we recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KIT-302, our lead drug candidate developed to simultaneously treat pain caused by osteoarthritis and to treat hypertension," said Kitov's CEO, Isaac Israel. "We are confident in the quality of the submitted package, and look forward to a response from the FDA shortly regarding whether the NDA is complete and acceptable for filing."In addition, we have expanded our pipeline with NT-219, a promising cancer therapy candidate, through the acquisition of a controlling interest in TyrNovo. Results from pre-clinical studies of NT-219, a small molecule, demonstrated its efficacy in overcoming drug resistance in a variety of cancers and in combination with multiple pharmacologic cancer therapies. We are focused on advancing this highly promising therapeutic candidate into clinical trials in 2018 in order to provide enhanced treatment options to cancer patients."With the completion of the recent equity offering, we are well positioned to accomplish our strategic initiatives in 2018. Our plan is to continue growing Kitov as an innovative, emerging pharmaceutical company. Our mission is to leverage the significant potential of our product development pipeline to create long-term shareholder value."
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Post by jerojuujarvi on Sept 4, 2017 6:24:01 GMT
Interesting article. Looking forward about this topic.
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Post by hansgruber on Sept 25, 2017 14:01:13 GMT
Stock is moving. I think we're due from the FDA soon...
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Post by JHam on Sept 25, 2017 15:11:34 GMT
Stock is moving. I think we're due from the FDA soon... Yep, supposed to happen before the end of this month.
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Post by JHam on Oct 2, 2017 13:29:52 GMT
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Post by bernstein on Oct 6, 2017 14:00:29 GMT
Bought my shares at $1.90 back which i sold at $2.20 ..Love the huge Potential here especially because of its dirt low valuation of only $21 Million .GL Kitov Announces FDA Acceptance of NDA for KIT-302 www.baystreet.ca/articles/research_reports/lifesci/Kitov100317.pdfKIT-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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