Revive Therapeutics Ltd. (OTC: RVVTF) (CSE: RVV): Management Believes That The Company Holds A Rich Portfolio of Licenses and Intellectual Property That Differentiates It & Sets It Apart…
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We’re now living in a world bound by COVID-19. But it’s not only a vaccine we need to worry about, it’s all of the lasting side-effects that come with it. Not only the economic ramifications but the health risks as well. For this reason, it will be important to have an eye on coronavirus stocks for the foreseeable future.
This Could Be Just the Beginning for Coronavirus Stocks
What has been the significant factor for making money with coronavirus stocks? Being early.. The fact that not one but multiple coronavirus stocks have produced thousands in percentage gains means that there is likely a huge focus on what’s next.
While the first wave of speculation taught us a lot and produced record-setting gains, the next wave of “undiscovered” coronavirus names could deliver even more. While some emerging stage and even well-established biotechs are trying to create a brand-new host of options, the smart money is betting that possible treatments exist, and they just need to be repurposed for COVID-19. One company could actually be holding that key as we speak.
(OTC: RVVTF) (CSE: RVV)
For smart investors, the next big thing to come about in the coronavirus-era are means to not only prevent the virus but also address issues caused by it if and when it is contracted. As the coronavirus (COVID-19) outbreak continues, we’re learning more about the disease, what it does to the body and the damage it can cause.
Although many people with COVID-19 have no symptoms or only mild symptoms, a subset of patients develop severe respiratory illness and may need to be admitted for intensive care. As Dr. Mukhopadhyay explains, Chinese researchers have linked COVID-19 to acute respiratory distress syndrome, or ARDS. Their study examined risk factors for 191 confirmed coronavirus patients who died while being treated in two hospitals in Wuhan, China.
The researchers found 50 of the 54 patients who died had developed ARDS while only nine of the 137 survivors had ARDS. Whether it occurs at home or at the hospital, ARDS can be fatal. People who survive ARDS and recover from COVID-19 may have lasting pulmonary scarring. This is something that is also realized in a host of other viruses including pneumonia and chronic influenza. So this is not just something isolated to COVID-19 leaving more potential for a viable treatment if and when a coronavirus vaccine is discovered.
For investors, the next coronavirus stock to watch is a huge focus and when you talk about timing and opportunity in the market, getting your eyes on the next potential company to break out is key.
Recommendation: Go Directly To Phase 3
It’s quite rare to talk about stocks under $1 in the same breath as talking about companies with a U.S. FDA recommendation to go into Phase 3 studies before conducting any other Phase trials. But that’s the importance of timing right now when it comes to Revive Therapeutics Ltd. (OTC: RVVTF) (CSE: RVV). Where other companies are trying to recreate the wheel, Revive has direct access to a drug that could be a prime candidate for repurposing and applying to COVID-19 patients immediately.
How? A Potential Silver Bullet Known As Bucillamine
In the past, Revive Therapeutics (OTC: RVVTF) (CSE: RVV) has explored the use of Bucillamine in the treatment of acute gout flares in a Phase 2 study in the U.S. This was under its Investigational New Drug (IND) application that was granted and accepted by the U.S. FDA.
Additionally, Revive Therapeutics (OTC: RVVTF) (CSE: RVV) explored the use of Bucillamine in the treatment of cystinuria, a cause of cystine stones in the kidneys. It received FDA orphan drug status and its IND was also accepted by the FDA to conduct a Phase 2 study in the United States. If this wasn’t enough, Bucillamine has been prescribed for treating arthritis for over 30 years in places like Japan and South Korea. So when looking for a treatment with a history of anti-inflammatory characteristics as well as proven acceptance by organizations like the U.S. FDA, Bucillamine can stand out.
According to Revive Therapeutics (OTC: RVVTF) (CSE: RVV) Bucillamine has unrealized potential for the treatment of influenza with both proven safety and proven mechanism of action similar to that of something known as NAC, or N-acetylcysteine. NAC is important for a variety of health reasons — including replenishing the most powerful antioxidant in your body, glutathione. These amino acids also help with chronic respiratory conditions, organ vitality, fertility and brain health.
Revive Therapeutics (OTC: RVVTF) (CSE: RVV) stresses that Bucillamine is 16-fold more potent than NAC as a thiol donor in vivo, giving it vastly superior function in restoring glutathione and therefore greater potential to prevent acute lung injury during influenza infection. Considering similarities at a biological level between influenza infections it may not be unreasonable to think that this could possibly justify the investigation of Bucillamine as a key treatment and intervention for COVID-19…
Validation Is The Ultimate Factor
This couldn’t be more true: Validation is key. Anyone can say “X could possibly justify Y” but Revive Therapeutics (OTC: RVVTF) (CSE: RVV) has something bigger backing up this justification. The company received positive feedback from the U.S. FDA in response to the Company’s Pre-Investigational New Drug (“pre-IND”) meeting.
The FDA recommended that Revive Therapeutics (OTC: RVVTF) (CSE: RVV) proceed directly into a Phase 3 confirmatory clinical trial to evaluate Bucillamine for the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection in order to “ensure expeditious evaluation of the safety and efficacy of Bucillamine.”
The FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout to support the COVID-19 Phase 3 study. Therefore, the company doesn’t have to perform any Phase 1 or Phase 2 clinical studies. It is currently in the process of preparing its IND for the Phase 3 study. The company received approval from the independent Institutional Review Board at Advarra for its Phase 3 clinical trial protocol. Advarra is a premier IRB services company in North America.
“With the IRB approval of the Phase 3 study protocol for COVID-19, we can recruit U.S. clinical sites efficiently, allowing us to move forward with providing Bucillamine to patients under our IND that was approved by the FDA [in July],” said Michael Frank, Revive’s Chief Executive Officer.
What’s more, Revive has also applied for a provisional patent with the U.S. Patent and Trademark Office entitled, “Use of Bucillamine in the Treatment of Infectious Diseases” to further secure its position in the market. Revive Therapeutics has also signed a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP in mid-August 2020. This is to establish Attwill as a resource for clinical packaging and distribution for Revive’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.
Attwill is one of the largest contract Lyophilization services facilities in the USA. It even has its own MOU with Vaxart, Inc. affirming the parties’ intent to establish Attwill as a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine…and Revive already has “the inside” on Attwill! Revive Director Bill Jackson is quite literally an insider of Attwill. The primary activities that Attwill may perform for the Phase 3 clinical study in COVID-19 are analytical and stability studies, clinical supply chain management, storage, distribution and project management.
More Than Just Another Coronavirus Stock: Pioneering Psilocybin-Based Pharmaceuticals
But as with any leading pharmaceutical company, it isn’t just about 1 drug but an entire pipeline that addresses multiple indications. Medical cannabis was in its infancy in the public markets back in 2013 and 2014 but it was the early investors who scored some of the biggest windfalls from early entrants into the arena. A new trend has begun to emerge on the fringes of the pharma-world: Psilocybin.
Call it “shrooms” or call it “psychedelics” that facts are the same. Research is starting to show a direct correlation to the use of psilocybin-based pharmaceuticals and successful treatments for “untreatable” diseases. With its acquisition of Psilocin Pharma Corp., Revive Therapeutics (OTC: RVVTF) (CSE: RVV) is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.
The company entered into a sponsored research partnership agreement with the University of Wisconsin-Madison to evaluate novel formulations and drug delivery technology focused on psilocybin-based pharmaceuticals. Under the agreement, Dr. Reed and his research team will evaluate psilocybin-based formulations and the patented Tannin-Chitosan composite drug delivery technology for psilocybin, in which the Company has an exclusive license with the Wisconsin Alumni Research Foundation.
Revive Therapeutics Enters into Clinical Trial Agreement to Evaluate Psilocybin for the Treatment of Methamphetamine Use Disorder
In Q3 of 2020, Revive entered into a Clinical Trial Agreement with the Board of Regents of the University of Wisconsin System (UWS). The company will conduct a clinical study entitled, “Phase I Study of the Safety and Feasibility of Psilocybin in Adults with Methamphetamine Use Disorder.”
Under the terms of the CTA, the Company has an exclusive option to obtain an exclusive, worldwide, royalty-bearing commercialization license to all rights, title, and interest that UWS may have or obtain in any invention that results from the clinical study.
The study will be conducted at the University of Wisconsin Schools of Medicine and Public Health and Pharmacy, which hold a Wisconsin special authorization and Drug Enforcement Administration license to perform clinical research with psilocybin.
Unique Drug Delivery Technology
The delivery technology is a natural, non-toxic, biodegradable and biocompatible composite. It combines a tannin material derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties. It’s also made up of a chitosan material derived from the crustacean group having blood-clotting and antimicrobial properties.
This delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation. The fact that Revive Therapeutics (OTC: RVVTF) (CSE: RVV) is not only producing novel psilocybin treatments but also developing a unique drug delivery technology could offer opportunities far beyond treatment.
It can possibly open doors to breakthroughs in drug delivery for myriad other treatments as well. This is always something to think about when it comes to leading biotechs. Are they focused on just one thing or are they building a versatile pipeline that is dynamic across multiple treatments and methods of treatment?
Revive Therapeutics (OTC: RVVTF) (CSE: RVV) has key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens). Furthermore, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.
What Other Assets Does Revive Own?
Revive also has a cannabinoid pharmaceutical portfolio. This focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.
Revive aims to build a portfolio of FDA orphan drug designations of cannabinoids that are complementary to Revive’s cannabis-based pharmaceuticals initiatives that support the long-term potential of cannabinoid prescription medicines for rare diseases and disorders. The company believes this has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX®.
Why Revive Therapeutics Ltd.
(OTC: RVVTF) (CSE: RVV)
- Revive Therapeutics (OTC: RVVTF) (CSE: RVV) is one of the few companies still flying under the radar as one of the few undiscovered infectious disease/ coronavirus stocks holding a true asset supported by FDA and the suggestion to go right to Phase 3 Trials.
- Revive Therapeutics (OTC: RVVTF) (CSE: RVV) already has a proven drug that has a strong safety history and was developed with multiple indications and proven efficacy with Phase 2 trials.
- Revive Therapeutics (OTC: RVVTF) (CSE: RVV) has more than just pharmaceuticals to rely on. It’s a partnership with the Wisconsin Alumni Research Foundation gives it an exclusive license to patented Tannin-Chitosan composite drug delivery technology. Its IP also consists of numerous patents and provisional patents filed.
- According to company management, Revive Therapeutics (OTC: RVVTF) (CSE: RVV) is one of the few companies that have unique formulations giving it direct exposure to an emerging trend in Psilocybin-pharmaceuticals. A first-mover advantage.
- While early names have gone to trade much higher, the next round of coronavirus stocks could be offering immediate opportunity. With a market cap of less than $20 million, Revive Therapeutics (OTC: RVVTF) (CSE: RVV) could be one of the lowest-priced biotech stocks that is actually looking at moving towards the final steps of Phase 3 trials
- Revive Therapeutics (OTC: RVVTF) (CSE: RVV) has begun the process of uplisting to the OTCQB Market exchange in the US.