ifox, Author at Small Cap Exclusive

5 Days & Counting – Final Preparations Made Before Cannabis Goes Legal In Canada

Canada is just days away from becoming the 2nd and largest country in the world to legalize cannabis.

The day is almost upon us. A day that has been anticipated by recreational users and investors alike as the last 3 months of build up have resulted in a massive boom for the green industry.

On October 17, Prime Minister Justin Trudeau is expected to make good on a campaign promise to allow for the growing, possession, and consumption of marijuana for recreational purposes a little over 5 years after the country of Uruguay pioneered legislation on the issue.

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Note: Derivative products such as edibles, cosmetics and e-cigarette products containing pot will not be allowed until 2019.

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According to MedicalExpress.com, stats say that 5.4 million Canadians will buy cannabis in legal dispensaries in 2018—about 15 percent of the population. 4.9 million already smoke.

Legalization is expected to boost the Canadian economy, generating $816 million to $1.1 billion in the fourth quarter of which A $400 million tax revenue windfall is forecast as a result.

Key Takeaway: Legalization in Uruguay was a pioneering effort and was therefore largely ignored by the world stage. On the other hand, the world is now forced to closely watch and see how Canada proceeds. The long term fate of the green industry rests on what happens in North America’s most northern country. Expect growing pains, shortages, booms and busts as is expected when a brand new economy springs up overnight, but above all stay focused and use Canada as the example for what to expect if/when a 3rd country is to legalize cannabis in the near future.

Citius Pharmaceuticals (NASDAQ: CTXR) Successfully Raises $10 Million

Citius Pharmaceuticals Successfully Raises $10 Million – CTXR announced today that the Company completed the largest capital raise in its history of $10 million, and insiders were responsible for supporting 50% of the raise. Mr. Myron Holubiak, President and CEO of Citius Pharmaceuticals, invested $1 Million in the Company and Mr. Leonard Mazur, Executive Chairman of Citius Pharmaceuticals invested $4 Million to bring the deal into fruition.

Myron Holubiak, President and CEO Stated: “Management once again demonstrated its confidence in a very tangible way in Citius and its late stage development program. We intend to use the capital from the raise towards our Phase 3 clinical Mino-Lok trial for the treatment of catheter related bloodstream infections (CRBSIs), and our Phase 2b clinical trial of CITI-002 for the symptomatic treatment of hemorrhoids. This raise should enable us to reach some critical milestones.”

Get The Full Report Here: https://finance.yahoo.com/news/citius-pharmaceuticals-successfully-raises-10-120000460.html

CTXR has always been on our radar and for good reason. Get the Key Catalysts below:

Up-list to the NASDAQ exchangePositive news: Citius Announced The Closing of $10Mil Underwritten Offering Priced At-the-MarketTiny float of 3.46 million shares, according to Yahoo FinanceSignificant insider ownership (About 60% according to Yahoo Finance)Citius Pharma offers a promising pipeline of late-stage treatments.CTXR has a long history of making double & triple digit gains for our membersCTXR received “Fast Track” designation by the FDA for the Mino-Lok™ Investigational TrialCTXR showed results of a 95% efficacy in salvaging infected catheters for Mino-Lok™

About CTXR‘s Products

Mino-Lok™

The Mino-Lok™ product is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs). CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs), and in hemodialysis patients where venous access presents a challenge.

The Mino-Lok™ product is intended to salvage the CVC obviating the need to remove and replace the catheter. This is a recognized unmet medical need. There are no alternatives other than the removal and reinsertion of the CVC once the CVC becomes infected. Studies show that removal and reinsertion of CVCs have a 15 to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.

The Mino-Lok™ product contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter.

The Mino-Lok™ product is used in two-hour locking cycles allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.

Program HighlightsPartnership with a leading cancer center and support from key industry opinion leaders.In a Phase 2b trial, the Mino-Lok™ product demonstrated a 100% efficacy rate in salvaging infected CVCs; the Mino-Lok™ product had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.FDA QIDP designation and patent protected until June 2024.Advancing to a Phase 3 pivotal superiority trial.

Pivotal Study Coming

Mino-Lok was originally developed by clinicians and technologists at the venerable M.D. Anderson Cancer Center. Through an exclusive worldwide license (excluding South America) signed in May 2014, Citius assumed control of the technology. Mino-Lok has recently been designated by the FDA as a Qualified Infectious Disease Product (QIDP), making it eligible for priority review, the FDA’s Fast Track program, and a five-year extension of market exclusivity under the Hatch-Waxman Act.

In a 90-patient Phase 2b trial, Mino-Lok demonstrated a 100% efficacy rate in salvaging infected CVCs. In addition, no significant adverse events were reported in the Mino-Lok arm compared to 18% serious adverse events in patients where the infected CVC was removed and replaced. Research on Mino-Lok shows it is able to eradicated some of the most difficult-to-treat pathogens, including Gram-positive, Gram-negative and fungi that are resistant to many of today’s antibiotics.

Citius is now preparing for a 700-patient, multi-center pivotal Phase 3 study. If enrollment, anticipated to include 50-65 clinical sites, goes as scheduled and the data validates the mid-stage research, Citius believes it can have a New Drug Application approved in about 30 months.

Hydro-Lido

As discussed in a recent press release from Citius, 10 million Americans suffer from hemorrhoids, a gastrointestinal disorder characterized by pain, swelling, itching and bleeding of hemorrhoidal veins. According to the National Institute of Health, about 75% of people will have hemorrhoids at some point in their life. Over 25 million units of over the counter topical hemorrhoid-treatment products are sold annually in the U.S.; and the estimated prescription market in the U.S. is over $1.0 billion.

The Company’s Hydro-Lido product is a proprietary topical formulation combining hydrocortisone and lidocaine. Hydrocortisone, an anti-inflammatory topical steroid, and lidocaine, an anesthetic product, are commonly used today to treat hemorrhoids. However, there is not a single product today, either alone or in combination, backed by safety and efficacy data collected through the clinical trial process to receive FDA approval for the treatment of hemorrhoids.

Data from a 210-patient Phase 2a study evaluating Hydro-Lido in patients with Grade I and Grade II hemorrhoids was released in February. The study was not powered to show statistical significance, but designed as a dose finding study to evaluate the optimal concentration of hydrocortisone and lidocaine in Hydro-Lido. As such, patients received either a placebo or one of six active drug treatments. Based upon patient feedback and physician assessments using the Global Score of Disease Severity, Hydro-Lido performed favorably compared to comparators with respect to faster onset of relief of symptoms and reduction in disease severity. In fact, Hydro-Lido seemed to achieve greater relief of pain, discomfort, and itching in only two days compared to either of its components alone.

Mr. Holubiak informed us that further study is needed since the Phase 2a trial was designed to identify an optimal concentration and the data are too small to jump to conclusions; but, Citius is now prepared to conduct a Phase 2b trial and get the most precise evaluation of the efficacy of combination of hydrocortisone and lidocaine. “Our goal with Hydro-Lido is to successfully complete a Phase 2b trial and have it Phase 3 ready in order to pursue licensing opportunities,” said Holubiak. “We’re talking about an untapped market with an FDA-approved therapy. With a growing aging population, the market is going to get even bigger. I suspect that there will be strong interest in Hydro-Lido with compelling data from a larger trial.”

The Company is preparing to initiate a 300-patient Phase 2b trial during 2017. With therapy only taking 14 days, this trial should move forward expeditiously.

Hydrocortisone and lidocaine are already both approved by the FDA separately. Citius can leverage safety data from the active ingredients to expedite development of Hydro-Lido through the FDA 505(b)(2) pathway. Not only does it shorten development time, but it also conserves cash resources and can open the possibility of other incentives, including extended market exclusivity.

All Star Management

Leonard Mazur, Chairman of the Board, Director

Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable accomplishments in founding, building and creating value and returns for investors. Mr. Mazur was the Chairman of Leonard Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He is the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products. Akrimax was founded in September 2008 and has successfully launched prescription drugs while acquiring drugs from major pharmaceutical companies. From January 2005 to May 2012, Mr. Mazur also co-founded and served as the Chief Operating Officer of Triax Pharmaceuticals LLC (“Triax”), a specialty pharmaceutical company producing prescription dermatological drugs. Prior to joining Triax, he was the founder and, from 1995 to 2005, Chief Executive Officer of Genesis Pharmaceutical, Inc. (“Genesis”), a dermatological products company that marketed its products through dermatologists’ offices as well as co-promoting products for major pharmaceutical companies. In 2003, Mr. Mazur successfully sold Genesis to Pierre Fabre, a leading pharmaceutical company.

Carol Webb, Director

From 2000 to 2005, Ms. Webb served as Company Group Chairman of Johnson & Johnson, and from 1987 to 2000 she served in capacities including President, Vice President, Executive Director, Product Management and Senior Product Director of Ortho Biotech. Ms. Webb has worked in various positions including Sales Representative, Sales Trainer, Product Manager and Manager of Public Policy at Roche Laboratories from 1972 to 1983. Carol has extensive experience in the oncology supportive care space and was responsible for the successful development and launch of several successful products, including PROCRIT® (epoetin alfa). Ms. Webb received her B.S. in Biology from Bowling Green State University.

Start your own research on CTXR immediately as this one is looking strong heading into next week. And, as always, stay tuned for more news and updates!

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Solar Integrated Roofing Corporation’s (OTCMKTS – SIRC) Pending Marketing Company Acquisition Integral to Nationwide Expansion Plans

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POWAY, CA, July 10, 2018 (GLOBE NEWSWIRE) — Solar Integrated Roofing Corporation (OTCPINK: SIRC) CEO Dave Massey said he was “tremendously excited” about the company’s most recent pending acquisition.

“This will be a revenue game-changer for us,” said Massey. “The target company has generated nearly $40 million in revenues since their inception 5 years ago, with more than $12 million of that coming in 2017 alone. They deliver over 14,000 leads across 43 states every month. This is a milestone event for SIRC. Acquiring a marketing company with a national footprint fits right in with our overall expansion goals and objectives. As the burgeoning growth of solar continues its upward trends across the country, this acquisition gives us the opportunity to showcase and market our industry expertise. Both companies will grow exponentially. We are tremendously excited about this deal!”

Massey added that the pending deal will also enhance the company’s continuing growth plans of acquiring roofing companies and converting them to solar companies as well. “SIRC’s solar and roofing expertise and track record allows for seamless integration of solar into existing roofing companies’ operations. Roofing companies we target as acquisition candidates will be very attracted to our business model and strategy,” he said.

About Solar Integrated Roofing Corporation

Solar Integrated Roofing Corporation (SIRC) is an integrated solar and roofing installation company specializing in commercial and residential properties with a focus on acquisitions of like companies to build a footprint nationally. For more information, please visit: www.solarintegratedroofingcorp.com

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Small Cap Exclusive is owned and operated by JBN PARTNERS LLC, which is a US based corporation. We are paid advertisers, also known as stock touts or stock promoters, who disseminate favorable information (this “Article”) about publicly traded companies (the “Profiled Issuers”).

We publish the Information on our website, smallcapexclusive.com and in newsletters, text message alerts, audio services, live interviews, featured “research” reports, on message boards and in email communications for specific time periods that are agreed upon between us and the Profiled Issuer and / or third party paying us. Our publication of the Information is known as a “Campaign”. This information may be sent to potential investors at different times that are minutes, hours, days or even weeks apart. Typically, the trading volume and price of a Profiled Issuer’s securities increases after the information is provided to the first group of investors. Therefore, the later an investor receives the Information, the more likely it is that he will suffer trading losses if they purchase the securities of a Profiled Issuer late in a Campaign. We are paid to advertise the Profiled Issuers, Solar Integrated Roof Corp. Small Cap Exclusive has been hired by a third party, Sunrise Media, LLC ., for a period beginning on March 25, 2018 to publicly disseminate information about (SIRC) via website and email. We have been compensated $200,000. We will update any changes to our compensation. We own zero shares of (SIRC).

Third Parties paying us to market the Profiled Issuer we believe intend to sell their shares they hold while we tell investors to purchase during the Campaign. International Cobalt is a penny stock that was illiquid (little to no trading volume) prior to our Campaign, and therefore these securities are subject to wide fluctuations in trading price and volume. During the Campaign the trading volume and price of the securities of each Profile Issuer will likely increase significantly because of the media exposure. When the Campaign ends, the volume and price of the Profiled Issuer will likely decrease dramatically. As a result, investors who purchase during the Campaign and hold shares of the Profiled Issuer when the Campaign ends will probably lose most, if not all, of their investment.