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.
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’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.
Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.
Shorts are desperate, I see. 700,000k to cover and no volume. Ed and his aliases abound, the reek of desperation.
So we now don't even have an active application for the Focal-1. Management still owns no more than a pittance of stock. Despite EU approval, they can't make anything of the European market. Earnings for the second quarter are likely to be lousy. And we have another ineffective PR outfit. And we have had to pay an "opinion maker" (where did they ever come up with such a stupid term?) to try to talk up this mess. WHAT A DEBACLE!
From 5/15-6/15, short interest increased from 160k to 770k, this period was edap price from 2.4-3.8 From 6/15-6/30 short interest decreased from 770k to 740k, edap price was around 3.4-3.8 I think some shorts realized they cannot push back to 3- again and start to regret their mistakes
The next possible positive news for EDAP may come in the form of earnings...It is unfortunate that Focal 1 is taking as long as it is, but I do remember the starts and stops concerning their now approved device in the US market via the FDA...Patience is definitely a virtue when it concerns this company...
So mgmt has added another hog to the trough. A complete concession that they have no clue as to how to extract the company from this absolute mess they have created. How much money have they thrown at useless "advisors"?
A new application? Absolutely incredible incompetence. This really ought to be the final straw for Oczachowski.
@ $3.50 ah's , . , . , . , only 2 shares though.
Paying an "opinion maker" to say that the stuff is viable? Can they be any more desperate or indicate that they themselves have little hope?
These guys have always been way over their heads trying to enter the US market and we can see that they still are.
Is it possible with the study completed this year, and they are submitting these results as part of the new application? This trial was not just prostate ablation, but this is actually designated as prostate cancer treatment. This would be huge. Just a thought. Either way, I'm in this long and believe in this technology. Treatment centers/Dr.'s count is up to 207
This is now verging on hopelessness. How much are they throwing at the "key opinion leader" to say that he thinks the prostate cooker has some possibility? $100,000? More? Sheer desperation.
A Green Day for EDAP.
Frances, Rob Goode, Ed....you really shouldn't use all big adjectives in your post. It makes it too obvious that you are the same person.
The bottom line here is that this is a yooge disaster created entirely by bad management. Funny how there's always a pump and dump before every bad news.
Now we know who was the beneficiary of the pump-and-dump: "Hal Mintz decreased its stake in Edap Tms S A (EDAP) by 95.79% based on its latest 2016Q4 regulatory filing with the SEC. Sabby Management Llc sold 522,925 shares as the company’s stock declined 9.68% while stock markets rallied. The hedge fund run by Hal Mintz held 22,993 shares of the electromedical & electrotherapeutic apparatus company at the end of 2016Q4, valued at $76,000, down from 545,918 at the end of the previous reported quarter. Sabby Management Llc who had been investing in Edap Tms S A for a number of months, seems to be less bullish one the $93.27 million market cap company. The stock rose 1.26% or $0.04 reaching $3.22. About 75,787 shares traded. Edap Tms SA (ADR) (NASDAQ:EDAP) has declined 15.92% since July 13, 2016 and is downtrending. It has underperformed by 32.62% the S&P500."
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