I am seeing the same thing. Axim had a quantitative test, then the FDA wanted it to be qualitative and they complied, now it is back to quantitative...
Further proof that the FDA has absolutely no idea what it is doing. I'd classify this as an abuse of its power, not uncommon in the bureaucracy of today.
It seems like the FDA is fearful of putting a result (either qualitative or quantitative) on a test for at home use, for fear that the result might "mislead" an individual into believing they are protected from COVID (?)
At any rate, switching to "Research Use Only" is a good "lift and shift" approach for John H. to do at this time.
The EUA for at home use has been stalled for way too long.
Might as well go for what I believe should be a much easier to attain EUA for Immunopass for "Research Use Only", rather than the much more complicated and elusive "For Diagnostic purposes" EUA that they were seeking.
Bottom line: The FDA is fearful of making a commitment to the presence of a certain level of neutralizing antibodies as being indicative of a level of protection from COVID-19, especially since they just came off 2 years of BS "following the science" when it came to vaccinations and masks.
I guess NOW the scientific research just isn't there yet.
"Follow the science", when it comes to antibody levels and results in the hands of the people in order to make their own health decisions, just doesn't fit in with the political agenda at this time.
Good move by John H., though, I must say! This is a less lucrative but much easier way to get Immunopass to market, and it enables the science to use Immunopass to figure out more definitively what levels of antibodies offer what levels of protection.
If nothing else, it is a good introduction in order to get Immunopass out there and into the hands of the scientific and healthcare industries.
At home use can ultimately be sought at a later date.
A series of small baby steps, rather than the huge leap to success that John H. was going for.
...I just wish Axim had come to this (apparently inevitable) understanding/conclusion months ago...
These opinions are my own and are not intended as investment advice. If you feel that my statements are "Pumping", Propaganda, or manipulative in any way, please refrain from trading and seek medical treatment immediately.
