19 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 and South America with roughly 40.000 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)
Seriously, this company is no joke. Active for 27 years, trading publicly for 20year. 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).