its all about ythe US public and their life safety regarding medical Rx's
the Fed just doesn't willy-nilly let a product out into the public market place under their AHJ protection services - unless its gone through and substantial and strict testing requirements that protect one's life safety and health ...
however, this flunky CEO doesn't always beleve in US safety procedures or prodicols
It's called the "FDA Wall" and it's a real shame . In the first year of Covid there were likely 10's of thousands of small companies struggling to bring new products to market but without any support from anywhere...up against the Wall and Big Pharma.
Now...in a dead sector with no money countless new products , some that likely could have saved many deaths, new products sitting dormant with no support , no money and some with no future.