In early 2022, Neuralink filed an application with the US Food and Drug Administration (FDA) to receive approval to begin human clinical trials of its implant, but it appears that, at least for the time being, things will not go as planned.
Elon Musk expected them. According to the Reuters agency, seven active and former FDA officials say that the application has already been rejected, but so far the reasons that led the committee to this decision have not been made known.
Neuralink’s animal trials have been underway since 2018, and the next step in humans is considered major to make the project viable.
Typically the FDA receives applications for human clinical trials after at least two rounds of animal testing have been successfully completed. Although it is not known how many such studies Neuralink has conducted, the FDA notes that it takes about 8.5 years for a single drug to be approved, which is much longer than Neuralink’s existence itself. If there’s one thing Elon Musk is famous for, it’s his impatience, which is why he’s previously stated that he plans to start clinical trials of Neuralink’s implant at the end of 2020.
However, he doesn’t share the same philosophy as the FDA, while over the years there has been no shortage of reports of tragic effects on animals that received the implant. It is worth quoting the opinion of Kip Ludwig, former head of the Department of Neuroscience at the US National Institute of Health
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