Despite repeatedly promising that his brain-computer interface company Neuralink would start human clinical trials soon, Elon Musk failed to mention that US regulators denied the company's application to start testing the company's brain chips in humans last year.
The news underscores just how little weight Musk's infamously ambitious timeliness actually carry. According to Reuters, Neuralink only even submitted its application to the US Food and Drug Administration in early 2022.
The application was reportedly denied, with staffers telling Reuters that regulators had identified dozens of issues that had to be addressed first, as well as safety concerns over the company's plans to implant lithium batteries in humans.
Less than a year later, Musk renewed his promise that human trials would be just months away.
In short, the staffers are dubious that the company will be able to address these issues in time to meet Musk's overly ambitious deadlines.
And that kind of challenge is really getting to the billionaire CEO. In late 2020, sources told Reuters that Musk shouted angrily about the company's slow progress on getting regulatory approval until about 2am.
"He can’t appreciate that this is not a car," one source told the news agency. "This is a person’s brain. This is not a toy."
Musk has been promising Neuralink's human trials would start imminently since at least 2019.
In 2020, he promised the trials of the company's coin-sized brain chip, designed to eventually allow disabled patients to move and communicate again, would kick off in "less than a year."
Finally, in December, Musk promised human trials were just "six months away."
Neuralink isn't technically obliged to publicize if or why its application was rejected by regulators.
And besides, it's far from game over for the startup as it's not an uncommon occurrence. According to Reuters, only roughly two-thirds of all FDA applications for human trials get approved after the first application.
Musk, however, has characteristically made some extremely bold promises about the future of the technology that didn't acknowledge those behind-the-scenes difficulties.
The billionaire CEO is also known for butting heads with regulators, who he largely sees as an impediment. Like with his other ventures, including Tesla and SpaceX, Musk's approach has, broadly speaking, been "move fast and break things."
In the medical field, however, that kind of mindset may not get you very far.
"Everybody in the industry was saying: ‘Oh my God, they’re going to run straight into a brick wall,'" Kip Ludwig, former program director for neural engineering at the US National Institutes of Health (NIH), told Reuters. "Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon."
Now, Neuralink is racing to get more data from animal trials to appease the FDA's concerns.
But there may be even more regulatory stumbling blocks for the company to come. Last month, Reuters reported that Neuralink may have illegally moved hazardous pathogens, thereby breaking federal law.
Then there's Neuralink's competition, with rival brain-computer interface startup Synchron already getting the go-ahead to start human trials last year.
The company is also dealing with major shakeups among its leadership. Musk himself is already spread very thin with his other ventures and pays very little attention overall to Neuralink, sources told Reuters.
Neuralink clearly has its work cut out in getting approval from the FDA. After all, the risks involved are palpable — introducing a battery-powered device inside the brain and zapping certain areas is pretty invasive.
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