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Tag: Lucira

  • From FDA Milestone to Bankruptcy Auction: Three Shocking Lessons from the Lucira Health Saga

    During the COVID-19 pandemic, the at-home medical test went from a niche product to a household staple. With a quick swab, we gained the confidence to visit family or board a plane. At the forefront of this revolution was Lucira Health, the company that developed the very first at-home COVID-19 test authorized by the FDA.

    Lucira was a pioneer, a symbol of rapid innovation when the world needed it most. Yet its story took a shocking turn. How could a company that achieved a historic public health milestone collapse into bankruptcy almost overnight? The saga of Lucira Health offers a series of stunning lessons about the harsh realities that exist between a breakthrough idea and market success.

    1. You Can Get Landmark Approval and Go Bankrupt in the Same Week

    Lucira Health’s collapse unfolded with the brutal irony of a Greek tragedy. On February 22, 2023, the company officially filed for Chapter 11 bankruptcy protection. It seemed like the end of the road for the struggling diagnostics firm.

    Then, just two days later, on February 24, 2023, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Lucira’s most ambitious product yet: the first-ever over-the-counter test that could detect and differentiate between COVID-19 and Influenza A/B from a single sample. The approval was hailed as a monumental achievement.

    “Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home.” — Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

    So, how could a company achieve a “major milestone” while simultaneously going bankrupt? The answer lies in a perfect storm of regulatory delays and high-stakes financing.

    • Lucira’s Explanation: The company stated that the “protracted EUA process” for the combination test was incredibly costly, draining its resources and forcing it into bankruptcy before the approval finally came through.
    • The FDA’s Response: Officials countered that the delay was necessary. An early version of the test submitted by Lucira allegedly contained a “toxic substance” that made it unsuitable for home use. After a redesign, a subsequent version lacked sufficient clinical data to assess its performance, causing further delays.
    • The Hidden Condition: The final blow was a critical, undisclosed term in Lucira’s loan agreement with Silicon Valley Bank. The agreement reportedly required Lucira to secure FDA approval for its combo test by a specific deadline. Missing that deadline triggered a massive interest rate hike that made the company’s financial situation untenable.
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  • Information Blockade: A Flawed System, Tainted Actors, and the COVID-19 Response

    Information Blockade: A Flawed System, Tainted Actors, and the COVID-19 Response

    A defective system governing taxpayer-funded research, coupled with questionable corporate actors, hampered the nation’s ability to respond to the COVID-19 crisis. This information blockade had dire consequences, not only for public health but also for the very companies that were supposed to be at the forefront of innovation.

    The problem stems from a long-standing policy that has prioritized corporate profits over public access to critical information. In 2013, the Obama administration’s White House Office of Science and Technology Policy (OSTP), then led by Director John P. Holdren, issued a memorandum entitled “Increasing Access to the Results of Federally Funded Scientific Research.” This memo established a 12-month embargo period, allowing publishers to lock away taxpayer-funded research for a full year.This delay, a significant impediment in a rapidly evolving public health crisis, was a compromise to appease the highly profitable academic publishing industry.

    This dysfunctional system created a breeding ground for opportunism and mismanagement.

    • Delayed Access, Stalled Innovation: The 12-month embargo meant that crucial data on clinical trials, epidemiological models, and virology was often obsolete by the time it became freely available. This left not only the American public in the dark, but also the very companies developing diagnostic tools. The Freedom of Information Act (FOIA) process, which should have provided a swift path to public data, was also rendered ineffective, with requests for vital information stalled for years, well beyond the supposed two-week turnaround for a clear and present danger.
    • Corporate Casualties and Questionable Practices: The story of Lucira Health exemplifies the devastating consequences of this information bottleneck. The company, which developed a promising combined COVID-19 and flu test, was financed by Silicon Valley Bank (SVB) and Hercules Capital, securing a debt facility of up to $80 million. However, Lucira was forced to file for Chapter 11 bankruptcy after a slower-than-anticipated FDA Emergency Use Authorization (EUA) process for its new test created a fatal cash crunch. Pfizer then acquired the company’s assets for a mere $36.4 million. The collapse of SVB, which held deposits for numerous Chinese companies, has also raised concerns. Treasury Secretary Janet Yellen confirmed that uninsured depositors in SVB, including those with ties to the Chinese Communist Party, would be made whole by the American banking system. This has led to questions about potential conflicts of interest, especially given the belief that the COVID-19 virus originated in a lab in Wuhan, China.
    • A System Admitting Failure: In a tacit admission of the system’s shortcomings, the White House OSTP issued a new memo in August 2022, mandating that all taxpayer-funded research be made freely and immediately available by the end of 2025, effectively ending the 12-month embargo. While a welcome change, this comes as cold comfort for the companies and the public who were failed by a system that prioritized profits and secrecy over transparency and innovation during a critical time of need.

  • MAGA F*cked: Astra (ASTR) Elites Win, Retail Loses

    MAGA F*cked: Astra (ASTR) Elites Win, Retail Loses

    April 2025 statements by founder Chris Kemp only deepen my conviction that public shareholders were deliberately misled while insiders ultimately benefited from the company’s orchestrated failure and privatization.

    The buyout price of $0.50 per share represented a near-total loss for those who invested during or after the SPAC merger, when the company claimed a multi-billion dollar valuation. The timing is deeply suspicious: only after the company finalized its take-private transaction in the March-July 2024 timeframe, acquiring valuable assets built with public shareholder funds (including the profitable satellite engine business acquired via Apollo Fusion) for pennies on the dollar through what founder Chris Kemp cynically termed a “Founder Led Acquisition Company” (FLAC) – bullshit terminology for which I have video evidence – did they announce, in May 2024, winning a U.S. Space Force Space Systems Command contract for the ‘Ascent’ mission. This sequence strongly suggests that public investors were used and discarded once the valuable core of the business could be secured privately by the founders, conveniently timed with securing new government contracts.

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