Stay Strong and Hold - Don’t sell too cheap With EUA for REVEALCOVID-19 PLUS Total Antibody test around the corner and a focus on production of 50.000 units PER DAY you should think twice before selling too cheap. A significant news release will push this over all time high easily.
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My original due diligence: 25 reasons why MedMira's upside is so huge (UPDATED)
UPDATE: MedMira introduced a new, significantly improved version of its total antibody test, called REVEALCOVID-19 PLUS, at the end of December 2020. Currently awaiting FDA Emergency Use Authorization.
The upside (risk-reward ratio) is huge for MedMira and I am really really confident they will receive FDA approval. Haven't sold a single share (quite the opposite). Here's why:
- REVEALCOVID-19™ is MedMira's once in a lifetime opportunity to grow from startup into a serious diagnostics player. A product with global demand, which can be produced and distributed inexpensively with a (probably) solid profit-margin. Family Meile and the team won't let this opportunity pass by. (drive and enthusiasm)
- Covid-19 getting even worse in the US, EU and South America with roughly 200.000 new cases PER DAY (growing market)
- REVEALCOVID-19™ Total Antibody Test is being currently manufactured at MedMira’s FDA-licensed (establishment license 3003595936) and ISO-certified Halifax facility
- MedMira has completed registration process and affixed CE mark to its rapid REVEALCOVID-19™ total antibody test in May
- MedMira is hiring like never before - "MedMira has ramped up its weekly production within a short period of time and has substantially increased its existing and trained work force in order to meet the increasing demand for its product."
- One advantage MIR has over most of the market competition is that it identifies 3 Antibodies out of 5 (competitive advantage) - especially IgA. IgA detection show the highest sensitivity after 4-25 days
- MedMira's technology, Rapid Vertical Flow, is patented - Simultaneous detection of multiple biomarkers on a single device
- WebbDx , the exclusive US distributor, put real money on the table and ordered 3.5 Mio. USD worth of MedMira's (not-yet approved) REVEALCOVID-19™ product
- WebbDx completed the process to do business with the U.S. Government (as of Aug 14th, check Cage code 8MTX2 at sam.gov)
- WebbDx seems to plan export of products to Greece and Turkey (https://s3-us-west-2.amazonaws.com/cdn.ceo.ca/1fjfcnl-5A01CDBB-E35E-4605-9920-E0828BF337B3.png)
- After allowing access to the US market under EUA notification, FDA now has to weed out a huge number of unusable test kits (removed 114 as of Sep 4th 2020). Only the best will we approved and Medmira is still under review!
- WebbDx and MedMira have become quiet on social media and news in general - maybe they are just very careful and don't want to risk leaking any information (as it happened with the 3.5 Mio. agreement)
- MedMira and WebbDx Management / Board members are accomplished experts in their field and have very strong connections and insights into the FDA approval process
- MedMira Insiders (former early employees, directors, investors, board members) have not chosen to sell their stock / options
- Same product setup already got FDA approval (only difference is the cartridge)
- "Helping WebbDX navigate the FDA was something I was proud to do" - Congressman Aderholt (who will chair the House Appropriations subcommittees that govern the FDA and HHS)
- "The FDA also stated in the letter that its current thinking on antibody tests was that they should have a minimum combined sensitivity of 90% and a minimum specificity of 95%. For tests that report specifically IgM and IgG, minimum sensitivity values of 90% and 70% for IgG and IgM respectively are called for." (Source: https://www.evaluate.com/vantage/articles/news/policy-and-regulation/fda-gets-aggressive-covid-19-antibody-tests)
- No doubts anymore about MedMira's accuracy regarding FDA standards - High sensitivity of REVEALCOVID-19™: >7 days after symptom onset – 99.1% & zero cross-reactivity (i.e. no false positive results). Source: https://www.globenewswire.com/news-release/2020/09/03/2088827/0/en/REVEALCOVID-19-Total-Antibody-Test-Sensitivity-and-Cross-Reactivity-Analysis.html
- No stock dilution in sight (according to Hermes Chan's letter)
- Antibody testing is essential before and after vaccination - With vaccines around the corner, demand will be outstanding and hard to handle for MedMira
- MedMira reported additional independent performance evaluation results of REVEALCOVID-19™ Total Antibody Test and the results were compared to two EUA approved serological tests ( https://www.globenewswire.com/news-release/2020/10/07/2105012/0/en/MedMira-reports-additional-independent-performance-evaluation-results-of-REVEALCOVID-19-Total-Antibody-Test.html )
UPDATE DECEMBER 2020
- "The increase in revenue of 74% for fiscal 2020 compared to fiscal 2019 is the direct result of the Company’s launch of its REVEALCOVID-19TM Total Antibody Test." (MedMira FY2020 Q4 and Year End Results)
- Huge manufacturing increase - "In the third and fourth quarter of FY2020, MedMira’s Operations team efficiently increased the weekly production in order to meet the growing demand for its REVEALCOVID-19TM Total Antibody Test by expanding its manufacturing team 10-fold." (MedMira FY2020 Q4 and Year End Results)
- Additional revenues from Switzerland (probably EU distributor ConvirmDX) - "Subsequent to the end of the fiscal year 2020, the Company has generated additional revenues from product sales and from a product development contract in the amount of CHF 500,000 equal to approximately CAD $750,000" (MedMira FY2020 Q4 and Year End Results)
- MedMira introduced the new REVEALCOVID-19 PLUS Total Antibody test. Fully validated with 100% specificity according to cross-reactivity study. MedMira’s REVEALCOVID-19TM Total Antibody Test that addresses the total antibody testing demands arising from recent developments in COVID-19 vaccines across global markets.
- Focus on production of 50.000 units of REVEALCOVID-19 PLUS Total Antibody Test daily! Hermes Chan, CEO of MedMira Inc. "“This shall enable us to introduce the new product version and address the additional market demands, focussing our attention on the production of 50,000 units of REVEALCOVID-19™ PLUS Total Antibody Test daily. This will position MedMira as a major contender in the coming months, as the vaccines are now being administered globally. The knowledge gained during the original EUA application has been invaluable.” (https://www.globenewswire.com/news-release/2020/12/31/2151927/0/en/MedMira-Announces-Product-Update.html)
Seriously, this company is no joke. Active for 27 years, trading publicly for 20 years. They waited years for this opportunity and will take full advantage of it. They are now at the right place, at the right time. Keep calm and stack shares (as they are still cheap now).
Why MedMira's new test is a game changer
Be honest to yourself: Do you understand why MedMira developed the "new" test and has even withdrawn their current application from the EUA list to resubmit the new one? A lot of people here and on other sites don't seem to grasp the huge improvement and significance of MedMira's new REVEALCOVID-19 PLUS Total Antibody test (reacting to demands from the market and regulators) and why it's necessary to detect antibodies against the N (nucleocapsid) and S (spike) proteins of SARS-Cov-2 virus:
It helps to understand whether antibodies have been built from a (past) natural infection or triggered by a vaccination using the Pfizer/BionTech or Moderna vaccines. Many current candidate vaccines aim to induce an antibody response against the SARS-CoV-2 spike protein.
MedMira's improved test is an incredibly useful tool not only in worldwide vaccine studies, but increases the confidence of a persons immune status BEFORE and AFTER vaccine administration.
Furthermore, I couldn't find any other antibody test detecting antibodies against both proteins in one swoop.
Big pharmaceutical players like Roche from Switzerland (hint ;) recognized this opportunity and improved their products as well - and got U.S. FDA approval shortly after!
Roche receives FDA Emergency Use Authorization for new test to measure the level of SARS-CoV-2 antibodies
Link: https://www.roche.com/media/releases/med-cor-2020-12-02.htm
MedMira meets FDA requirements
Futhermore, I found some interessting details about FDA performance requirements. Excerpts from their updated (as of June 26th) "Serology Template for Commercial Manufacturers":
"Ideally, performance characteristics are established in a clinical study with prospective samples [...] Clinical agreement data should be provided using at least 30 unique antibody positive samples from 30 patients for each immunoglobulin claimed and 75 unique antibody negative samples from 75 patients tested for SARS-CoV-2 and confirmed as negative, or 75 unique samples collected prior to December 2019, and the data should demonstrate a minimum of the following:
(PPA NPA = positive and negative percent agreement)
For tests that detect either total antibodies, only IgG or only IgM:
PPA of 90% and NPA of 95% "
So FDA requires at least:
PPA of 90%
NPA of 95%
Now the interessting part begins - MedMira data from the REVEALCOVID-19 package insert:
Venous Whole Blood Samples
Thirty-seven (37) SARS-CoV-2 negative whole blood samples (collected in K2 EDTA tubes) were assessed with REVEALCOVID-19TM Total Antibody Test prior to studies
PPA = 97.1%
NPA = 100.0%
Plasma Samples
Thirty-seven (37) RT-PCR confirmed SARS-CoV-2 positive and 124 negative (collected between 2013 and 2015) plasma samples were tested.
PPA = 97.1%
NPA = 98.1%
Serum Samples
Thirty-one (31) RT-PCR confirmed SARS-CoV-2 positive and 110 negative (collected between 2013 and 2015) serum samples were tested.
PPA = 100.0%
NPA = 99.0%
So if I have read and understood everything correctly, MedMira REVEALCOVID-19 meets the FDA requirements easily.
By the way, share freely with your friends and other MedMira investors. Understanding its products and market goes a long way for all of us.