Didn’t they have every opportunity to conduct a trial given they started outside the US in Prospera, an autonomous zone of Honduras?

“So to start, they’ll be selling Lumina in Prospera, a libertarian charter city in Honduras. Prospera allows the sale of any biotech product under an informed consent rule: as long as the company is open about risks and the patient signs a waiver saying they were informed, people can do what they want.”

https://www.astralcodexten.com/p/defying-cavity-lantern-biow...