Re:Nuclear startup Oklo gets thumbs-down from regulators
by epistasis on Friday January 14, 2022 @04:13PM
(#29940523)
It sounds like Oklo didn't bother to try to figure out what the regulators wanted, since they didn't bother to answer the questions of regulators.
I've done some first mover approval work in biology, and yes it's more work, but all first movement is more work in every way because you're pioneering something new. The FDA, at least, is not unreasonable and is usually very open about the bar they think they need to set. You just need to talk to them, request a meeting, and show up. And also realize that it's going to be an iterative process, as any new product design process is also iterative.
I've done some first mover approval work in biology, and yes it's more work, but all first movement is more work in every way because you're pioneering something new. The FDA, at least, is not unreasonable and is usually very open about the bar they think they need to set. You just need to talk to them, request a meeting, and show up. And also realize that it's going to be an iterative process, as any new product design process is also iterative.