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.
Monster Microcaps Alert to APRI shareholders. Clean Energy Technologies (CETY) opened their Europe Sales and Service Center for Europe sales and to serve 65 existing customers with CETY’s General Electric clean energy heat recovery systems and has already sold the first of hundreds of units to come.
Each CETY Heat Recovery System sells for $300,000 and market demand is reported to several BILLION DOLLARS.
CETY purchased Heat Recovery Systems in 2015 from General Electric and products are now very attractive to huge unmet markets and can achieve over $250 million annual sales within the next 2 years. Demand for conversion of wasted heat to electrical energy in big applications is VERY LARGE AND UNMET.
Shares are steal with target of $.20 by year end and higher in 12 months.
Clean Energy Technologies, Inc. Secures New Order for Waste Biomass Application in Europe
COSTA MESA, Calif., July 12, 2017 /PRNewswire/ -- Clean Energy Technologies, Inc. (CETY) announced today that its subsidiary Heat Recovery Solutions has secured a new Clean CycleTM generator order for a Waste Biomass application in Europe. Growing d
26 countries approval still lost .17 cents next earning.
What has these shares so firm (LOL)? Tremendous volume and it looks like it wants to run. I think the sale of the X-US rights may have been part of a much larger plan...
OK, wow, this thing will be huge in US. ED affects millions. If this cream is approved in US as it has been in the other 26 countries, think about it...no more pills. throw this thing on and your good. OMG....Why is this so cheap, especially with the sale and closing they just did?
well once again...Pascoe was wrong he said on the conference call he would hear frim the FDA in Q2...well that did not happen,,, anyone want me to list the 12 other mistakes Pascoe has made to date? some include a Canada Abbott Vitaros launch and launches that never happened.... another a Femprox partner in Europe that never happned etc etc all lies? or is he just greatly mistaken to the point of being delusional?
APRI's product, Vitaros, has already been approved in 26 countries including ones with sophisticated health agencies. That's why Ferring bought the non-US rights. With such widespread use and patient experience, it's very likely to be approved in the U.S., too, which would be the biggest market, of course. Argentina, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
So the FDA approval of this new drug resubmission is anticipated for Q3, what's the potential of this new drug in dollars to APRI and its shareholders? Need some homework here, since they let go of there Ex operations to Farring, what are they making money on now?
APRI may be a compelling opportunity. Im not sure about you guys but awe.some.stocks has provided me with some pretty good trade ideas. I messed up executing some of them but thats on me.
I just wonder one thing.. will I get TUMORS on my WeeWee from APRI Cream like experimental mice in that study? Why did FDA Deny??... Tumors on mice WeeWees?? What's the real story here??
(TOPS) IS MOVING UP!
Monster MicroCaps SPECIAL ALERT to APRI shareholders – NWBO $.19 and climbing, just announced $11 million financing with convertible debt payable in 3 years at $0.25, $.50 and $1.00. NWBO expected to release final Phase III Trial results any day from now until mid-July. If results are comparable to preliminary data, shares likely to explode to yield enormous percentage gains. Announcement could be huge because DCVax-L and DCVax Direct are also proven effective against 13 common cancers and has only mild fever as potential side effect. This breakthrough immunotherapy might replace the $100 Billion chemotherapy market. https://finance.yahoo.com/news/nwbio-closes-3-convertible-debt-154100683.html
NWBio Closes 3-Year Convertible Debt Exchange and Financing, and Completes Payoff of Last $5 Million of 2014 Bonds
This completes the Company's payoff of $11 million in principal amount of bonds, plus associated interest and forbearance fees, over the period from March through June of this year in accordance with an installment payment agreement with the bondhold
X axis : Stocks Price Correlation Coefficient Y axis : Quantity of stocks Sep-2016 1,000 Day Parameter 2,830 NASDAQ Stocks Price Analysis This stock mode of correlation coefficient is -0.8 In other words, the correlation coefficient of the other stoc
Pascoe time to derliver, you said you'd hear from the FDA by 2nd quarter about Vitaros U.S. well one week left, deliver or i add it to your endless list of 'fibs? wrongfullness......?
IGXT (MC $46 M)US-NDA Submission for BLOCKBUSTER Drug this month =1000%+ Upside Potential ! PLEASE READ THIS
2 US-NDA submission within 2 months ,lot of Cash and heavily underpriced at a valuation of just $46 million .1 Big drug partnered with Endo Pharma already under review by FDA market launch expected in 1H 2018 .Load up guys before she the MEGA news hit the wire and thank me later .GL
MarketCap $46 Million Cash ~$12 Million (including convertible debt) =cash untill 2021+ Price: 0.70
NDA submission for tadalafil (erectile dysfunction) thin-film version of Blockbuster drug Cialis in June or July NDA resubmission for Rizaport (migraine) in early Q3 Partnership for Tadalafil in 2H 2017
IntelGenx previously confirmed the bioequivalence of Tadalafil to Eli Lilly’s Cialis, which had sales of $1.5-billion in 2016 but faces generic competition in 2020. IntelGenx has an exclusive license for oral films from Lilly for its dosing patent, which would allow Tadalafil to enter the ED market in the U.S. free from patent litigation from Lilly. Dr. Matzen explains that Tadalafil, which offers a discrete dosing alternative, could enter the market in 2018, with up to three years of market exclusivity before Cialis is hit with generic competition.
Tadalafil is an erectile dysfunction (ED) treatment that boasts bioequivalence with Cialis, the current leading brand, and with a successful biostudy in-hand a 505(b)(2) NDA is set to be filed any day now, meaning that a full launch should be expected in mid-2018. Cialis is already winning-out over Viagra in terms of numbers of prescriptions, which is largely down to price and efficacy, but when Tadalafil comes to market with the same product in a more convenient and discreet delivery mechanism, IntelGenX should see a massive number of customers take-up its services.
IntelGenx has multi-faceted BD approach for its oral films
With a burgeoning pipeline of pharmaceutical oral films, IntelGenx’s (OTCQX:IGXT; TSXV:IGX) business development strategy is focused on partnering its product pipeline along with actively meeting with potential partners to explore manufacturing
Any reason for this uptick?
The Typed words within this post is/are just Speculative thinking on my part,and I may be 100% incorrect and so take it as speculation only and not fact? I cant help, but to wonder, if the move in the Share price today with volume,is due to bad News? such as a Reverse/Split?maybe information about a proposed Reverse/Split,was leaked ,and knowing that a Reverse/Split, is a Negative event, generally, and causes the Share price to decline once a Press/Release is made public, and so for that reason they inflate the Share price allowing some to liquidate their positions at higher prices before the Bad News hits the street VIA a Public P/R? PS if anyone has any information as to the reason for the increase in Share price please replay
Is pascoe going to finally keep a promise about FDA decsion on Room Temperature Device this June? he said he should hear back from the FDA by Q2 that means only June is left in Q2 and we are in June!!!!!
BOD has got to wake up and make an example of pascoe for all his errors in judgement to date, imo, get rid of the guy, Trump would have told him years ago, "You are fired"!!!"
think about it, us shareholders paid $50M for fispemiphene 3 years ago. a drug that sat on the shelves since 2005? and pascoe rushes in to buy all U.S. rights from a near bankrupt European company, only to discover the reason no one else wanted to buy it..it was a total failure. Why is Pascoe still here?