FDA Question of MedMira's PlatformMedMira mentioned that the FDA had questions about thier platform, not test validation (that we know of). Going by what they publicly shared, the only concern one would reasonably have is - will this platform in question hamper approval? I do not know the answer to that, however, in my "I'm Just Joanna" opinion, the likelyhood of approval looks great because of the below. If the platform has been already FDA approved in other uses, perhaps, perhaps, the transferable technology will suffice. I know the notion that just because it worked once, doesnt mean it will work twice stands true on some occasions. In the end all we can do is research, analyse, and report our findings with what is available, critical thinking, sentiment, history, and some hope with a pinch of luck.
"MedMira’s technology platform and growing portfolio of diagnostic tools demonstrate excellence in performance and quality in the highly competitive diagnostics industry. More than $30 million has been invested in perfecting MedMira’s core technology, which has proven itself time and time again with its excellent clinical performance and its success in rigorous evaluations and inspections, leading to regulatory approvals for rapid diagnostic solutions in the United States (U.S. Food and Drug Administration), Canada (Health Canada), the notified body in the European Union (CE Mark), and China (CFDA) and in a number of countries in Latin America, Africa, and Asia. The Company’s quality system is ISO 9001 and ISO 13485 certified. The Company’s patented Rapid Vertical Flow® (RVF) platform has proven to be highly flexible and versatile. Such RVF® adaptability enabled the development of the new rapid serological test (REVEALCOVID-19™ Total Antibody Test) in the early 2020. During that time, MedMira’s R&D team was able to make the product in a short time frame, with the developmental cost being one of the lowest documented for MedMira. This achievement highlights RVF® versatility as well as further indicates the platform’s great adaptability potential that enables efficient product development while still maintaining the highest product standards. MedMira sells its rapid tests through a network of medical distributors and strategic business development partners to customers in all sectors of the healthcare industry, including laboratories, hospitals, point-of-care clinics, governments, aid organizations, and public health agencies."(Reference SEDAR: MD&A)
Goodluck ALL