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With a Trump-driven reduction of nearly 2,000 employees, F.D.A. will Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’

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  • No. I was hoping they'd be blueberry flavored!

    That's on the way out

  • Can AI reliably tell if a cat is longer than a banana yet?

    An african cat or a european cat?

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    ai has a place in drug development, but this is not how it should be used at all

    there should always be a reliable human system to double check the results of the model

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    So we're going to depend on AI, which can't reliably remember how many fingers humans have, to take over medical science roles. Neat!

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    This country is fucking toast moment #236

  • Discouraging use of artificial dye is a good idea. It interferes with people's ability to make health conscious choices. Requiring labeling would be a great start.

    Food dye is used to cover up a lot of food crime. Most of us wouldn't eat food that needs to be dyed to look safe to eat, if it weren't dyed, if we had a choice.

    Using AI to fast track food regulations is a terrible idea.

    Edit: Good point that "artificial" is part of their witch hunt wording. I only mean we could probably do with less dye use, or clear labels on what has been dyed.

    its coming from worm brains who consumes methlyene blue, which is a dye in itself.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    i think people will go over to canada, or even mexico for real drugs, no ones going to risk a "supplement" like industry.

  • Don't lose too much sleep over it.

    This is likely going to be "Oops, all placebos!" in our future.

    Taking a drug that doesn't work is not necessarily the same as taking a placebo. I have suffered a lot from drug side effects, and some have hurt me long-term, years after I stopped taking the medicine. I am incredibly wary of taking anything new, even before all the horrors of 2025. With even worse approval processes, I expect that a lot of harmful and potentially debilitating or deadly stuff is going to end up on pharmacy shelves soon.

  • Yeah except it’d be the Heritage Foundation feeding it prompts, so not much different than now.

    Monkey paw finger curls inward

  • So we're going to depend on AI, which can't reliably remember how many fingers humans have, to take over medical science roles. Neat!

    Different types of AI, different training data, different expectations and outcomes. Generative AI is but one use case.

    It's already been proven a useful tool in research, when directed and used correctly by an expert. It's a tool, to give to scientists to assist them, not replace them.

    If you're goal to use AI to replace people, you've got a bad surprise coming.

    If you're not equipping your people with the skills and tools of AI, your people will become obsolete in short time.

    Learn AI and how to utilize it as a tool, you can train your own model on your own private data and locally interrogate the model to do unique analysis typically not possible in realtime. Learn the goods and bads of technology and let your ethics guide how you use it, but stop dismissing revolutionary technology because the earlier generative models weren't reinforced enough get fingers right.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Things LLM can't do well without extensive checking on large corpus of data:

    • summarizing
    • providing informed opinions

    What is it they want to make "more efficient" again? Digesting thousands of documents, filter extremely specific subset of data, and shorten the output?

    Oh.

  • Different types of AI, different training data, different expectations and outcomes. Generative AI is but one use case.

    It's already been proven a useful tool in research, when directed and used correctly by an expert. It's a tool, to give to scientists to assist them, not replace them.

    If you're goal to use AI to replace people, you've got a bad surprise coming.

    If you're not equipping your people with the skills and tools of AI, your people will become obsolete in short time.

    Learn AI and how to utilize it as a tool, you can train your own model on your own private data and locally interrogate the model to do unique analysis typically not possible in realtime. Learn the goods and bads of technology and let your ethics guide how you use it, but stop dismissing revolutionary technology because the earlier generative models weren't reinforced enough get fingers right.

    when directed and used correctly by an expert

    They're also likely to fire the experts.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    IF bribe_received: return ("Approved")

  • ai has a place in drug development, but this is not how it should be used at all

    there should always be a reliable human system to double check the results of the model

    I have to quibble with you, because you used the term "AI" instead of actually specifying what technology would make sense.

    As we have seen in the last 2 years, people who speak in general terms on this topic are almost always selling us snake oil. If they had a specific model or computer program that they thought was going to be useful because it fit a specific need in a certain way, they would have said that, but they didn't.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    People will die because of this.

  • Efficiency =/= Accuracy or safety

    I can efficiently put a screw in drywall with an electric drill, but it doesn’t mean it will hold it up or attach it to anything.

    Furthermore, something can be efficient in different ways depending on the criteria. Something can even be efficient in one context and inefficient in a different one. Efficiency as they use it is too vague.

  • I also prefer 100% natural ground insects in my food over artificial dyes.

    (Just teasing for funsies)

    Ricin is natural and one of the most potent plant-produced poisons.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    My experiences with most AI is that you really, really need to double check EVERYTHING they do.

  • People will die because of this.

    I'll try arguing in the opposite direction for the sake of it:

    An "AI", if not specifically tweaked, is just a bullshit machine approximating reality same way human-produced bullshit does.

    A human is a bullshit machine with an agenda.

    Depending on the cost of decisions made, an "AI", if it's trained on properly vetted data and not tweaked for an agenda, may be better than a human.

    If that cost is high enough, and so is the conflict of interest, a dice set might be better than a human.

    There are positions where any decision except a few is acceptable, yet malicious humans regularly pick one of those few.

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    If you're a developer, a startup founder, or part of a small team, you've poured countless hours into building your web application. You've perfected the UI, optimized the database, and shipped features your users love. But in the rush to build and deploy, a critical question often gets deferred: is your application secure? For many, the answer is a nervous "I hope so." The reality is that without a proper defense, your application is exposed to a barrage of automated attacks hitting the web every second. Threats like SQL Injection, Cross-Site Scripting (XSS), and Remote Code Execution are not just reserved for large enterprises; they are constant dangers for any application with a public IP address. The Security Barrier: When Cost and Complexity Get in the Way The standard recommendation is to place a Web Application Firewall (WAF) in front of your application. A WAF acts as a protective shield, inspecting incoming traffic and filtering out malicious requests before they can do any damage. It’s a foundational piece of modern web security. So, why doesn't everyone have one? Historically, robust WAFs have been complex and expensive. They required significant budgets, specialized knowledge to configure, and ongoing maintenance, putting them out of reach for students, solo developers, non-profits, and early-stage startups. This has created a dangerous security divide, leaving the most innovative and resource-constrained projects the most vulnerable. But that is changing. Democratizing Security: The Power of a Community WAF Security should be a right, not a privilege. Recognizing this, the landscape is shifting towards more accessible, community-driven tools. The goal is to provide powerful, enterprise-grade protection to everyone, for free. This is the principle behind the HaltDos Community WAF. It's a no-cost, perpetually free Web Application Firewall designed specifically for the community that has been underserved for too long. It’s not a stripped-down trial version; it’s a powerful security tool designed to give you immediate and effective protection against the OWASP Top 10 and other critical web threats. What Can You Actually Do with It? With a community WAF, you can deploy a security layer in minutes that: Blocks Malicious Payloads: Get instant, out-of-the-box protection against common attack patterns like SQLi, XSS, RCE, and more. Stops Bad Bots: Prevent malicious bots from scraping your content, attempting credential stuffing, or spamming your forms. Gives You Visibility: A real-time dashboard shows you exactly who is trying to attack your application and what methods they are using, providing invaluable security intelligence. Allows Customization: You can add your own custom security rules to tailor the protection specifically to your application's logic and technology stack. The best part? It can be deployed virtually anywhere—on-premises, in a private cloud, or with any major cloud provider like AWS, Azure, or Google Cloud. Get Started in Minutes You don't need to be a security guru to use it. The setup is straightforward, and the value is immediate. Protecting the project, you've worked so hard on is no longer a question of budget. Download: Get the free Community WAF from the HaltDos site. Deploy: Follow the simple instructions to set it up with your web server (it’s compatible with Nginx, Apache, and others). Secure: Watch the dashboard as it begins to inspect your traffic and block threats in real-time. Security is a journey, but it must start somewhere. For developers, startups, and anyone running a web application on a tight budget, a community WAF is the perfect first step. It's powerful, it's easy, and it's completely free.
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    PSA OP "wikipediasuckscoop" seems to have a personal vendetta against wikipedia. All their posts are various articles bashing the site.
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    I still get calls, but I can't see details (e.g. just the phone number, not the caller).
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    glizzyguzzler@lemmy.blahaj.zoneG
    Indeed I did not, we’re at a stalemate because you and I do not believe what the other is saying! So we can’t move anywhere since it’s two walls. Buuuut Tim Apple got my back for once, just saw this now!: https://lemmy.blahaj.zone/post/27197259 I’ll leave it at that, as thanks to that white paper I win! Yay internet points!
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    Small progress is still progress. Kick management in the dick, friends.
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    Make them publishers or whatever is required to have it be a legal requirement, have them ban people who share false information. The law doesn't magically make open discussions not open. By design, social media is open. If discussion from the public is closed, then it's no longer social media. ban people who share false information Banning people doesn't stop falsehoods. It's a broken solution promoting a false assurance. Authorities are still fallible & risk banning over unpopular/debatable expressions that may turn out true. There was unpopular dissent over covid lockdown policies in the US despite some dramatic differences with EU policies. Pro-palestinian protests get cracked down. Authorities are vulnerable to biases & swayed. Moreover, when people can just share their falsehoods offline, attempting to ban them online is hard to justify. If print media, through its decline, is being held legally responsible Print media is a controlled medium that controls it writers & approves everything before printing. It has a prepared, coordinated message. They can & do print books full of falsehoods if they want. Social media is open communication where anyone in the entire public can freely post anything before it is revoked. They aren't claiming to spread the truth, merely to enable communication.
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    swelter_spark@reddthat.comS
    Yeah, I don't prefer that. But with some things I feel like it's barely a downside, and I'd put Boxes into that category. It's useful and well-designed enough in terms of functionality that I'm willing to overlook the Gnominess.
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    ... robo chomo?