It is such an honour to share with you today one more piece of exciting news stemming from our commencement of an FDA approval pathway for Ivectosol™ as well as providing an update on the official start of our BSL-4 and dose sparing adjuvant trials!
First things first, we are thrilled to share that we have sent out a media release this morning announcing that MVMD has contracted Camargo Pharmaceutical Services to support MVMD’s pursuit of U.S. Food and Drug Administration (FDA) approval of its novel Ivectosol™ rapid dissolve oral format for human applications.
This is a very significant and important initiative!
Camargo is recognized as one of the most experienced global organizations who specialize in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) investigational new drug and new drug applications (NDA), preparations and submissions, including participation in more than 1100 Agency meetings and more than 200 FDA NDA and Abbreviated New Drug Application approvals.
In the words of Mike Farber, our head of Life Sciences “After successful pre-clinical studies of our novel solubilized Ivectosol™ sublingual in our pre-clinical trials, this is a critical next step in the approval process to support our human application objectives. Camargo will be a great partner to accelerate our efforts for the initial pre-IND presentation to the FDA outlining Ivermectin's prior usage history and extensive safety record for the FDA’s assessment and approval pathway.”
Bottom line, we are moving quickly down a pathway with our novel solubilized Ivermectin sublingual wafers for FDA approval, through proof of absolute superiority, efficacy and safety, paving the way for us to realize our vision to have Ivectosol™ products be the number one commercial form of Ivermectin in the world.
What’s more and as promised, we are also incredibly pleased to announce that we have successfully formulated our Ivectosol™ product and provided trial quantities to our Bio Safety Level 4 (“BSL-4”) laboratory partner. The trials are immediately commencing as scheduled and we couldn’t be more thrilled.
As previously outlined, the study is designed to prove the superiority of the Company’s solubilized Ivermectin technology versus commercially available oral form in speed and efficacy of COVID-19 viral clearance and will also include the more virulent B.1.351 South African COVID-19 variant.
Inactivated Polio Vaccine – Dose Sparing Adjuvant
Additionally, I am pleased to share that the dose sparing adjuvant formulation work for the Inactivated Polio Vaccine has been completed and Tulane University School of Medicine has confirmed it will be commencing its trials the week of March 8, 2021.
You can read the full media release on our website at:
We are living in truly exceptional times and I have to say that I couldn’t be prouder of how our team of change makers has worked tirelessly in pursuit of our vision to make this world a better place. As we’ve said all along…we are on a mission to stop needless deaths and ensure more life. More fathers, mothers, sisters, brothers, sons, daughters and friends.
So, thanks to you, to our Mountain Valley MD team, partners and family too…we are changing the world and we continue to reimagine what is possible.
President & CEO, Mountain Valley MD