Mr. Markus Meile reports
MEDMIRA S JULY UPDATE AS PER THE IIROC REQUEST
Medmira Inc. has issued a statement to address the request from the Investment Industry Regulatory Organization of Canada (IIROC) and comment on the recent increase in the price of the company's shares. MedMira is not aware of any material change in its business affairs that has not been publicly disclosed and could account for the recent increase in market activity.
RevealCOVID-19 total antibody test is being currently manufactured at Medmira's Food and Drug Administration-licensed (establishment licence 3003595936) and ISO-certified Halifax facility under strict good manufacturing practices (GMP). 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. The company has started shipping
RevealCOVID-19 total antibody test, RVF-based rapid serological assay that detects total antibodies to the SARS-CoV-2 virus, the causative agent of COVID-19, in human serum, plasma and venipuncture whole blood, to its exclusive distribution partner, WebbDX. Medmira is extremely pleased that, at the time of the continuing COVID-19 crisis, the company could bring
RevealCOVID-19 total antibody test to the market, as well as create new jobs.
In April, Medmira announced the development of RevealCOVID-19 total antibody test. In early May, the emergency use authorization (EUA) application was successfully submitted to seek the United States FDA product authorization. At this time, Medmira's EUA application is still being reviewed. Medmira would like to re-emphasize that EUA review is a very interactive process that involves continuing communications between the FDA and Medmira. Time required to receive the FDA product authorization under EUA varies on a case-by-case basis; thus, the timeline of the EUA review cannot be defined. Medmira's unique and patented Rapid Vertical Flow platform differs from the commonly used lateral flow technology, prompting different questions from the FDA and may result in a longer lead time. While awaiting the FDA authorization, however,
RevealCOVID-19 total antibody test can be distributed in the United States as per the FDA policy.
About Medmira Inc.
Medmira is a leading developer and manufacturer of Rapid Vertical Flow diagnostics. The company's tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV and Hepatitis C, in just three easy steps.
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