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Good morning.  I am pleased to provide you with a some very exciting news.  This morning we distributed a media release announcing our patent filing to protect the IP around a breakthrough that enables the drug ivermectin to be up to 5,000 times more water-soluble without the use of organic solvents – a critical requirement to enable the drug to be dosed by injection or inhalation in humans.
 
Our release outlines the many reasons and implications of how this new technology could become critical to develop a significant therapeutic in the fight against COVID-19 and numerous other viruses.  Many studies have confirmed that the use of ivermectin is associated with a lower mortality in hospitalized COVID-19 patients despite currently being limited to an orally dosed tablet with poor bioavailability, an issue that MVMD believes would be directly addressed with our new discovery.
 
Ivermectin is a well-documented anti parasitic drug being used globally in both veterinary and human medicine and its uses are being broadened to include such applications as an anti-malarial. Billons of world-wide doses annually are utilized in underdeveloped countries to protect most domestic and husbandry animals from parasites including poultry, pigs, cattle and horses.  Ivermectin has documented limitations due to its poor solubility in water (.005 mg/ml), thereby requiring the use of toxic organic solvents such as glycerol formal and ethanol – which of course would not make it possible in its current form for the FDA to approve for human injection form or a more bio-available oral solution.
 
Our scientists, while working on improving the inclusion of ivermectin into our patented Quicksome™ delivery system for current pre-clinical trial work, made this important discovery that they were able to make ivermectin highly water-soluble without the use of organic solvents, improving its water solubility by nearly 5,000 times.  The Company believes that this result would eliminate the main limiter of the drug ivermectin to achieve stronger pharmacokinetics and better overall efficacy. 
 
This quote from Mike Farber, our Director of Life Sciences at Mountain Valley MD is a great summary in my opinion of the broad implications of this breakthrough - “We believe this discovery to be a breakthrough that will enable the efficacy needed to treat respiratory infections such as COVID-19, influenza and tuberculosis by enabling the drug deposition into the airways and lungs through aerosol formulations and pulmonary delivery. This will also allow ivermectin to be administered to humans via syringe and intravenous therapy, presenting what we believe are unprecedented options to provide treatment for numerous viruses.”
 
Another critical element outlined in the media release is that our new discovery uses only excipients that are currently approved by the US Food and Drug Administration (FDA).  Our strategy is to license our intellectual property to global pharmaceutical, vaccine and nutraceutical third parties and as such, this discovery provides additional advantages to potential licensees as we believe it will enable  them to obtain FDA approvals more quickly based on there being fewer approval steps required for immediate applications in human and animal dosing. 
 
I would encourage you to read the full media release on our company website - https://www.mountainvalleymd.com/investor.
 
Our team continues to work at an unprecedented pace across an incredible portfolio of game-changing applications of our Quicksome™ technology.  As expected with our technology advancements, we are starting to attract global attention from world-class pharmaceutical, vaccine and nutraceutical companies and have had many meaningful discussions with potential partners as we shift towards a monetization focus for the company. I believe today’s news release will accelerate interest in new application license areas and accelerate the exploration of meaningful partnerships even further.  We have many exciting developments in our pipeline that I look forward to sharing in the coming weeks.
 
I think it is very fitting that we continue to work on technologies to save lives and improve the human condition, that this announcement falls on November 11th.  Here in Canada and across other commonwealth member states, we observe Remembrance Day, marking the day World War One ended, at 11am on the 11th day of the 11th month, back in 1918. Please take a moment today to pause at 11am to remember the incredible sacrifices made by those who were lost in the war fighting for our freedoms.
 
Wishing you continued health and safety!


Sincerely yours, 

Dennis

Dennis Hancock
President & CEO
 
Mountain Valley MD
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