For everybody coming disappointed from other Covid stocks. Here is my original due diligence why I've chosen MedMira. Still valid as of today:
22 reasons why MedMira's upside is so huge
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 )
- 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)
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).
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.