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Tuesday, February 6, 2024

NTSB Finds Alaska Air Boeing 737 Max Jet Had Missing Door Bolts

 A preliminary report released by the National Transportation Safety Board finds the mid-air incident with an Alaska Airlines Boeing 737 Max 9 jet last month was caused by a door plug that had not been properly attached before Boeing Co. delivered the plane. 

NTSB said the Max 9 jet was missing four bolts, which were supposed to serve as a fail-safe mechanism for securing the panel to the fuselage. 

X user Jason Rabinowitz, who reviewed the report, cited a line from NTSB's report: "Four bolts that prevent upward movement of the MED plug were missing before the MED plug moved upward off the stop pads." 

Rabinowitz said the report confirms that Boeing's fuselage-maker Spirit AeroSystems delivered the fuselages to the planemaker with defects around the door plug that required its opening. 

"Photos from Boeing actually show the door plug opened for work, then closed again ***without the bolts to hold it in place***," he said. 

And this. 

"We caused the problem," Boeing’s CEO Dave Calhoun said on a Jan. 31 earnings call.

Calhoun continued: "Over these last few weeks, I've had tough conversations with our customers, with our regulators, congressional leaders and more. We understand why they are angry, and we will work to earn their confidence."

Meanwhile, the NTSB's website that has the report crashed... 

Are the same folks who made Boeing Max jets now making websites? 

https://www.zerohedge.com/markets/ntsb-finds-alaska-air-boeing-737-max-jet-had-missing-door-bolts

Why Burn Books When You Can Bury Them? White House Pushed Amazon To Target Dissenting Books

by Jonathan Turley,

The House Select Subcommittee on the Weaponization of the Federal Government on Monday revealed yet another facet of the Biden Administration’s sprawling censorship system that targeted dissenting books.

It appears that, as with social media companies, it succeeded in getting the company not to promote disfavored books.

Judiciary Chairman Jim Jordan revealed on X that the White House was directly involved in the censorship campaign.

That includes a 2021 email from one Biden official asking to discuss “the high levels of propaganda and misinformation and disinformation of [sic] Amazon?”

Amazon in turn appears to ask only how high the Biden White House wants it to jump on censorship: “[i]s the [Biden] Admin asking us to remove books, or are they more concerned about search results/order (or both)?”

After the meeting, Amazon confirmed in an email that it was actively doing what the government demanded in suppressing sales by not promoting disfavored books:

“As a reminder, we did enable Do Not Promote for anti-vax books whose primary purpose is to persuade readers vaccines are unsafe or ineffective on 3/9, and will review additional handling options for these books with you.”

This effort notably parallels demands from Democratic leaders who have called for enlightened algorithms to frame what citizens access on the internet. In 2021, Sen. Elizabeth Warren (D-Mass.) objected that people were not listening to the informed views of herself and leading experts. Instead, they were reading views of skeptics by searching Amazon and finding books by “prominent spreaders of misinformation.”

Warren blamed Amazon for failing to limit searches or choices:

“This pattern and practice of misbehavior suggests that Amazon is either unwilling or unable to modify its business practices to prevent the spread of falsehoods or the sale of inappropriate products.”

In her letter, Warren gave the company 14 days to change its algorithms to throttle and obstruct efforts to read opposing views.

It is important to keep in mind that these efforts at censorship targeted scientists who have been vindicated in many of their objections to policies and claims of the government. For example, a new scientific review by  12 researchers from leading universities found little support for the claims that masks reduced Covid exposures.

The Centers for Disease and Control Prevention (CDC) initially rejected the use of a mask mandate. However, the issue became a political weapon as politicians and the press claimed that questioning masks was anti-science and even unhinged. In April 2020, the CDC reversed its position and called for the masking of the entire population, including children as young as 2 years old.  The mask mandate and other pandemic measures like the closing of schools are now cited as fueling emotional and developmental problems in children.

The closing of schools and businesses was also challenged by some critics as unnecessary.

Many of those critics were also censored. It now appears that they may have been right.

Many countries did not close schools and did not experience increases in Covid.

However, we are now facing alarming drops in testing scores and alarming rises in medical illness among the young.

Masks became a major social and political dividing line in politics and the media. Maskless people were chased from stores and denounced in Congress.

Then-CDC Director Dr. Robert Redfield said during a Senate hearing that “face masks are the most important powerful health tool we have.”

The head of the World Health Organization even supported censorship to combat what he called an “infodemic.”

A lawsuit opposing these efforts was filed by Missouri and Louisiana and joined by leading experts, including Drs. Jayanta Bhattacharya (Stanford University) and Martin Kulldorff (Harvard University). Yet, universities joined social media companies and politicians in targeting dissenters and silencing opposing voices.

Bhattacharya previously objected to the suspension of Dr. Clare Craig after she raised concerns about Pfizer trial documents. Those doctors were the co-authors of the Great Barrington Declaration, which advocated for a more focused Covid response that targeted the most vulnerable population rather than widespread lockdowns and mandates. Many are now questioning the efficacy and cost of the massive lockdown as well as the real value of masks or the rejection of natural immunities as an alternative to vaccination.  Yet, these experts and others were attacked for such views just a year ago. Some found themselves censored on social media for challenging claims of Dr. Fauci and others.

The media has quietly acknowledged the science questioning mask efficacy and school closures without addressing its own role in attacking those who raised these objections. Even raising the lab theory on the origin of Covid 19 (a theory now treated as plausible) was denounced as a conspiracy theory. The science and health reporter for the New York Times, Apoorva Mandavilli,  even denounced the theory as “racist.”

Again, the objection to the censorship system is not that all of these views are correct, but that the public was being actively hampered in reading or hearing opposing views.

The new emails also show direct federal efforts supporting censorship. I testified at the first hearing by the special committee investigating the censorship system. I warned that there was ample evidence of a system based on “censorship by surrogate” where government agencies used academic and media allies to silence those with opposing views.

Despite the determined opposition by Democratic members and the Biden Administration, the investigation has revealed a wide array of grants to academic and third party organizations to create blacklists or to pressure advertisers to withdraw support for conservative sites. The subjects for censorship ranged from election fraud to social justice to climate change.

Now we can add private demands to target dissenting books to suppress sales. It is far more appealing to certain sensibilities than banning publications or removing copies.  After all, why burn books if you can bury them?

https://www.zerohedge.com/political/why-burn-books-when-you-can-bury-them-white-house-pressured-amazon-target-dissenting

Immunome pays $50M for phase 3 desmoid tumor drug, playing catch-up with SpringWorks

 Barely two months after SpringWorks Therapeutics secured the first-ever FDA approval for a drug to treat ultra-rare desmoid tumors, Immunome has bagged the rights to a phase 3 therapy it claims could be more effective.

The Pennsylvania-based biotech is paying $20 million in upfront cash and $30 million in common stock to Ayala Pharmaceuticals to secure the phase 3 oral gamma secretase inhibitor AL102. The deal also covers an injectable gamma secretase inhibitor called AL101 that’s in a phase 2 trial for adenoid cystic carcinoma.

Should AL102 live up to the hype, Ayala is in line for development and commercial milestones totaling $37.5 million.

In this morning’s press release, Immunome claimed that “data from clinical trials have shown AL102 may be more effective in treating desmoid tumors” than SpringWorks’ own gamma secretase inhibitor Ogsiveo, which secured FDA approval at the end of November 2023. 

Desmoid tumors, which are diagnosed in around 1,650 people in the U.S. each year, are marked by noncancerous soft tissue growths that often cause severe pain and disfigurement. To secure the approval of Ogsiveo, SpringWorks drew on phase 3 data that showed a confirmed objective response rate of 41% for patients taking the drug compared to 8% for those who received placebo.

There have been no head-to-head studies of the two drugs. In today’s release, Immunome claimed that among evaluable patients in a phase 2 trial who received a 1.2-mg dose of AL102, the objective response rate so far has been 75%. This is the same dose being tested in Ayala’s ongoing phase 3 study.

“We are especially optimistic about the rapidity and depth of the tumor responses observed in the phase 2 portion of RINGSIDE,” Immunome’s CEO Clay Siegall, Ph.D., said in the release. “AL102 will complement our existing portfolio of targeted cancer agents that are approaching phase 1 trials.”

“As we complete the work required to advance AL102 to NDA submission, our goal is to bring clinical benefit to an underserved patient population while generating substantial value for stockholders,” Siegall added. “We also plan to investigate other populations of cancer patients that could benefit from treatment with AL102.”

Immunome gave itself a late Christmas present in the form of a slate of antibodies and related assets from Atreca, which it bought for $5.5 million upfront. The December 2023 deal included APN-497444, which was Atreca’s lead antibody-drug conjugate program in early development for gastrointestinal cancers.

https://www.fiercebiotech.com/biotech/immunome-pays-50m-phase-3-desmoid-tumor-drug-playing-catchup-springworks

Tenax Patent Broadening IP Protection for Levosimendan in Pulmonary Hypertension with Heart Failure OKd

 Once granted, this patent will:

  • provide U.S. intellectual property (IP) protection until December 2040, and may qualify for additional U.S. patent term extension (PTE) beyond 2040
  • broaden IP protection for oral (TNX-103), IV, and subcutaneous use of levosimendan, and its active metabolites (OR1896 and OR1855), in PH-HFpEF
  • expressly provide IP protection for levosimendan at all therapeutic doses for use in PH-HFpEF
  • expressly provide IP protection for levosimendan in combination with various cardiovascular drugs for use in PH-HFpEF
  • represent the third patent granted to Tenax since March of 2023 protecting the use of levosimendan in the treatment of PH-HFpEF

Big Explosion of Government and Social Assistance Jobs in 2023 to Help Migrants

 President Biden is bragging about job growth in 2023. But he doesn’t say where those jobs are.

Data from the BLS, chart and calculations by Mish.

A surge in immigration led to a surge in need for government and social assistance jobs at taxpayer expense. City and local governments are under financial strain.

In a White House Press Release on February 2, president Biden stated “America’s economy is the strongest in the world. Today, we saw more proof, with another month of strong wage gains and employment gains of over 350,000 in January, continuing the strong growth from last year.”

Things Biden Failed to Mention

  • The employment level fell by 683,000 in December.
  • Although jobs (nonfarm payrolls) rose in January, the employment level fell by 31,000.
  • Full-time employment decreased by 63,000 in January.
  • Of the 353,000 jobs created in January, 136,000 were government, social assistance, or health.
  • Over half the job growth in 2023 was government, social assistance, and health care.
  • Cities are struggling to keep up with migrants and the costs are soaring out of sight.
  • Inflation is not falling.
  • Year-over-year inflation is falling, partly due to easy year-over-year comparisons, despite inflationary pressures of Bidenomics regulations that will show up later.

Jobs Soar but Full Time Employment Is Barely Changed Since May 2022

Nonfarm payrolls and employment levels from the BLS, chart by Mish.

On February 2, I noted Jobs Soar but Full Time Employment Is Barely Changed Since May 2022

Payrolls are up by 5.77 million since May of 2022, but full time employment up only 457 thousand. No amount of BLS smoothing can hide this.

Is Inflation Down? That’s What President Biden Says

Please consider a December Statement from President Joe Biden on the December Consumer Price Index

Today’s report shows that we ended 2023 with inflation down nearly two-thirds from its peak and core inflation at its lowest level since May 2021. We saw prices go down over the course of the year for goods and services that are important for American households like a gallon of gas, a gallon of milk, a dozen eggs, toys, appliances, car rentals, and airline fares. Despite what many forecasters were predicting a year ago, inflation is down while growth and the job market have remained strong. The economy has created more than 14 million jobs since I took office, and wealth, wages, and employment are higher now than under my predecessor.

Consumer Price Index Change Since January 2020 Key Items

  • Home Prices (Through October): +45 Percent
  • CPI: +19 Percent
  • CPI Excluding Food and Energy: +18 Percent
  • Rent of Primary Residence: +21 Percent
  • Food: +25 Percent

For more numbers and discussion, please see Is Inflation Down? That’s What President Biden Says

Importantly, Inflation is not down. The CPI is not down.

Denver Health at “Critical Point” as 8,000 Migrants Make 20,000 Emergency Visits

As a direct result of migration Denver Health at “Critical Point” as 8,000 Migrants Make 20,000 Emergency Visits

Denver Health CEO Donna Lynne warned Denver Health is at a critical, critical pointEight-thousand migrants from Central America accounted for approximately 20,000 visits in 2023.

Denver Health asked the Federal Emergency Management Agency to provide funds for immigrants’ medical costs. The state and federal governments aren’t reimbursing the hospital, which spent $136 million for patients who didn’t pay.

New York City

In New York City, Mayor Issues Emergency Executive Order to Stem Migrant Arrivals

Under Bidenomics policy, we have created hundreds of thousands of jobs that are of net negative benefit to US taxpayers.

That’s what Biden is really bragging about.

https://mishtalk.com/economics/big-explosion-of-government-and-social-assistance-jobs-in-2023-to-help-migrants/

Major European Banks At Center Of Complex Iran Sanctions Evasion Scandal

 Ever since Obama's very short-lived nuclear deal with Iran was scrapped by the subsequent Trump administration, Tehran has ramped up its efforts at sanctions evasion, which has especially relied on a fleet of 'ghost tankers' sailing primarily to China.

But the story of the secret cooperation of reputable European banks, and sophisticated efforts to hide large Iranian transactions has been a more interesting development, and this week Lloyds and Santander UK (based in Spain) have been in the spotlight, causing their shares to take significant hits on Monday. One Europe-based broker has observed, "The market must be realizing that they may be fined."

Cedars-Sinai mental health app launches on Apple Vision Pro

 Right after the official launch of the new Apple Vision Pro mixed reality headset, Cedars-Sinai has launched a generative artificial intelligence (GenAI) app that will use the technology to provide mental health support for patients.

The app – eXtended-Reality Artificially Intelligent Ally, or Xaia – was created by clinicians and AI experts at Cedars-Sinai to provide conversational therapy and personalised coaching to patients in a calming virtual environment, alongside other exercises like deep breathing and meditation.

The therapy is delivered by a virtual avatar that has been programmed to simulate a human therapist, according to Xaia’s developers and, if needed, can also connect users with a licensed therapist for a virtual session. Other features include appointment scheduling, access to medical records, and management of medications.

“Apple Vision Pro offers a gateway into Xaia’s world of immersive, interactive behavioural health support – making strides that I can only describe as a quantum leap beyond previous technologies,” said Brennan Spiegel, director of Health Services Research at the Los Angeles-based institute and co-founder of the Xaia technology, which will be commercialised by a new start-up called VRx Health.

“With Xaia and the stunning display in Apple Vision Pro, we are able to leverage every pixel of that remarkable resolution and the full spectrum of vivid colours to craft a form of immersive therapy that’s engaging and deeply personal,” he added.

Apple Vision Pro device (Courtesy of Apple)
Apple Vision Pro device (Courtesy of Apple)

Apple launched the new headset last Friday at its flagship Fifth Avenue store in New York City, with some of the tech giant’s diehard fans queuing up to get their hands on the device, which has a starting price of $3,500.

Given that price point, it is perhaps not surprising that the company’s main strategy is not direct sales to consumers; rather, it is positioning Apple Vision Pro as an enterprise technology that can be used by companies and other large organisations. While it is early days, Cedars-Sinai’s announcement suggests it may make headway with that approach.

The headset also provides a companion to the Apple Watch for the company in wearables that can have health applications, and is the first major new product launch for the group since the watch’s debut in 2015.

Market watchers are not expecting massive sales, at least initially. Apple has reportedly trimmed down its launch expectations for unit sales in the first 12 months from 3 million, but analysts have suggested that its pricing and enterprise approach could keep that figure down below 200,000, according to a report in The Economist.

There are some key differences with rival VR headsets, like Meta’s Quest range, Valve Index, and HTC Vive Pro 2; notably, that there is no need to hold devices to interact with the mixed reality environment, as users do so using hand gestures. It also doesn't include a battery in the headset itself, making it smaller and lighter. That does mean, however, that the unit needs a cable to tether it to an external battery.

Apple is also trying to move away from the idea that the device is an augmented, virtual, or even a mixed reality headset, preferring to call it a “spatial computing” device, which reflects its desire to position it as a new way to interact with digital content and tools. It launches with around 600 apps and games available in the App Store.

https://pharmaphorum.com/news/cedars-sinai-mental-health-app-launches-apple-vision-pro