Cumbersome FDA regulations delay new drugs. It generally takes at least 10 YEARS to bring a new drug to market. The pandemic got regulators to say they’ll speed things up — but their process still holds up promising treatments.
I know about this first hand, because now I’m trying to help get a new treatment approved.
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Years ago, my older brother Tom, a medical researcher, discovered a protein called gelsolin that may save some people with diseases like Covid-19, pneumonia, & sepsis.
It’s being worked on by Tom’s old company, BioAegis: https://www.bioaegistherapeutics.com/
Gelsolin reduces excess inflammation. That should help Covid-19 patients, because many die NOT from the virus itself, but because their body’s own immune response causes too much inflammation. That destroys organs.
Despite gelsolin’s promise, even very sick patients can’t get access to it because it’s still winding its way through the FDA’s regulations.
Gelsolin got through animal studies, and also passed some human safety tests. But it can’t be given to patients until it passes all FDA’s tests. That usually takes years.
My brother died last year, so I’m now trying to help BioAegis raise funds to cover the FDA’s tests.
The video above explains more about Tom, gelsolin, and BioAegis’ efforts to get it into further FDA-required trials.