OAN Roy Francis
7:31 AM PT – Friday, March 3, 2023
The United States Food and Drug Administration (FDA) has rejected Elon Musk’s proposal for Neuralink to start human trials with its brain chip.
According to Reuters, on Thursday current and former employees reported that the FDA rejected the application in early 2022. The company was founded in 2016, but the proposal that was taken to the FDA in 2022 was the first time that the company had proposed its chip for human trial.
Since 2019, Musk has predicted that his company would start human trials for its revolutionary brain implant. The purpose of the implant that Neuralink is working on is to treat intractable conditions which would include conditions such as paralysis and blindness.
The rejection had not been previously reported, but staffers say that the agency had reported dozens of issues that Neuralink must address before being approved for human trials. The primary issue that was brought to the company was the use of the lithium battery in the chip. The FDA also expressed concerns about the potential of the implant’s wires migrating to other areas of the brain, and how the chip would be removed without damaging the brain tissue.
Musk’s has last said that his company would secure approval to move forward by this spring. However, staffers of the company are still working through the safety concerns brought up by the FDA, and are doubtful that the company would be able to address the issues by that deadline.
The rejection had tremendously raised the stakes for the company since the FDA said that it has previously approved almost two-thirds of all human trial applications on the first request. The percentage of approval rose to 85% after the second request.
Musk, however, still retains full confidence of the majority of his staff, and industry investors due to his record of success when taking on extreme challenges.
Co-founder of the venture capital firm ARCH Venture Partners, Bob Nelson, has invested personal funds into Neuralink, but he says he is still confident in Musk’s capability and drive.
“I definitely would never bet against him,” he said. “If he has some bumps in the road with Neuralink, or any other thing, he’ll regroup and figure it out. Just think about it: Those are hard industries with huge safety barriers – cars and rockets.”
Musk had detailed a very strong vision for his company for the future. He put forth the vision to the public of disabled and healthy people who will be able to visit facilities for quick insertions of the chips. The chips would be able to “cure” obesity, autism, depression, schizophrenia and would also enable web-surfing and telepathy.
The high ambitions brought forward by Musk have raised the company’s worth to over $1 billion. However, senior staffers at the company have more modest goals for the short term. Dongjin Seo, Neuralink’s vice president of engineering said that the immediate goal of the company is “to help paralyzed patients communicate through computerized text without typing.” He went on to say that the goals set by Musk are “long-term” goals.
The company’s relentless focus on speed has contributed to its problems. Reuters had also reported in 2022 that federal agencies were investigating the company’s treatment of research animals.
The U.S. Department of Agriculture’s Office of Inspector General is conducting a probe into claims that the company was causing additional suffering and death of pigs, sheep, and monkeys in its trials. The Department of Transportation was also investigating whether the company had illegally transported dangerous pathogens, on chips removed from monkey brains, without proper containment measures.
Neuralink faces stiff competition in its field. Other companies in the implant market include Synchron, Medtronic, Neuropace, and Blackrock Neurotech, all of which have already received approval for human trial, some of which have been also been selling products on the market for years now. Another competitor that Neuralink is facing is Precision Neuroscience which was co-founded in 2021 by former Neuralink founding member Benjamin Rapoport.
However, expectations for Neuralink are high due to the company’s high goals, and its owner’s past success and breakthroughs in areas that were deemed unrealistic.
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