> I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA. While the FDA is not perfect, such as m

> I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA. While the FDA is not perfect, such as medical devices regulation was in limbo and theranos, it did prevent many harmful drugs from enter market. When I was interning at FDA NCTR, the director then was very proud that they've prevented thalidomide, that causes deformities in newly born babies, from entering market.