And, Here Is What Amazon Spent $4.35 Million Lobbying On, In Q1 2024...

To be certain, here -- this is not a complete listing.

Far from it. I've decided to focus on the areas we cover here -- less about software and cloud computing and cybersecurity, and more about labor, and bioscience and patents and IP (and to those our pharma concerns lobby about). This is, though, about 70 percent of what Bezos' companies lobbied on:

. . .Issues related to broadband access and affordability, satellite communications, space safety, spectrum, device accessibility, Section 230 reform, content moderation, and online video, including the Satellite and Telecommunications Streamlining Act (S. 4010) and implementation of the Infrastructure Investment and Jobs Act (P.L. 117-58). . . .

Issues related to intellectual property, including copyright reform and online infringement, counterfeits, including the SHOP Safe Act (S. 3934), music licensing, patent reform, Copyright Office modernization, issues related to the Digital Millennium Copyright Act, and issues related to intermediary liability. . . .

Issues related to taxes, including renewable energy tax credits, digital goods and services, international and corporate taxation, the American Innovation and Jobs Act (S. 866), the American Innovation and R&D Competitiveness Act (H.R. 2673), Tax Cuts for Working Families Act (H.R. 3936), the Small Business Jobs Act (H.R. 3937), the Build it in America Act (H.R. 3938), the Tax Relief for American Families and Workers Act (H.R. 7024), and implementation of the Tax Cut and Jobs Act (P.L. 115-97). . . .

Issues related to data protection, encryption, data retention, data breach notification, data security, facial recognition technology, cross border data flows, privacy, law enforcement access, fraud prevention, product safety related to the sale of counterfeit and/or stolen products, including the Combating Organized Retail Crime Act (H.R. 895 / S. 140), and cloud computing, including the American Data Privacy and Protection Act (H.R. 8152). . . .

Issues related to immigration, high-skilled immigration, and non-immigrant visas, including issues related to employment-based visas, green card backlog, the STEM visa exemption provision, and Deferred Action for Childhood Arrivals (DACA). . . .

Issues related to technology, procurement, and space policy. . . .

Issues related to USDA SNAP online purchasing, including reauthorization of the Agricultural Improvement Act of 2018 (P.L. 115-334), Electronic Benefit Transfer, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and food safety. . . .

Issues related to veterans hiring and training, employee compensation and benefits, workplace safety, competition, contracting, and minimum wage, including the AMERICA Act (S. 1073), and a bill to provide that certain discriminatory conduct by covered platforms shall be unlawful, and for other purposes (AICOA) (S. 2033). . . .

Issues related to STEM education, computer science education, and job training in the CHIPS and Science Act of 2022 (P.L. 117-167), and implementation of the National Defense Authorization Act for Fiscal Year 2024 (P.L. 118-31). . . .

Issues related to health information technology, healthcare and telehealth, including the Telehealth Expansion Act (H.R. 1843 / S. 1001), the Telehealth Benefit Expansion for Workers Act (H.R. 824), the CONNECT for Health Act (S. 2016 / H.R. 4189), the Telehealth Modernization Act (H.R. 7623 / S. 3967), and the Primary Care Enhancement Act (H.R. 3029 / S. 628); and issues related to pharmacy, including the Prescription Information Modernization Act (H.R. 1503) and the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act (S. 3430); and issues related to Fiscal Year 2024 appropriations bills. . . .

Issues related to the Equality Act (H.R. 5 / S. 393), the Justice in Policing Act (draft bill - no number), and cannabis reform, including the States Reform Act (H.R. 5977) and the Cannabis Administration & Opportunity Act (S. 4591). . . .

Issues related to Amazons Climate Pledge, including alternative fuel vehicles, electric vehicle charging infrastructure, renewable electricity data, federal fleet electrification, maritime and shipping decarbonization, sustainable aviation fuel (SAF), and low-carbon R&D. Issues related to energy and environmental provisions in the Infrastructure and Jobs Investment Act (P.L. 117-58). . . .

Now you know -- we still have Amgen, and Pfizer to cover, next week. Now, onward, to Cinco! G'night one and all, of good will!

नमस्ते

NASA Highlights A Paper On "Synthetic Life" -- That Might Be Engineered In Zero Gravity...

There are profound ethical questions here. Ones that reasonable people will no doubt disagree about.

And to their credit, NASA scientists are not shying away from grappling with them. Because some of this will ultimately occur in zero gravity, the connection is. . . obvious -- and the paper below has a lead author who works at NASA.

". . .Cells are the fundamental units of life, forming the variety of all living things on Earth as individual cells and multi-cellular organisms. To better understand how cells perform the essential functions of life, scientists have begun developing synthetic cells – non-living bits of cellular biochemistry wrapped in a membrane that mimic specific biological processes.

The development of synthetic cells could one day hold the answers to developing new ways to fight disease, supporting long-duration human spaceflight, and better understanding the origins of life on Earth.

In a paper published recently in ACS Synthetic Biology, researchers outline the potential opportunities that synthetic cell development could unlock and what challenges lie ahead in this groundbreaking research. They also present a roadmap to inspire and guide innovation in this intriguing field. . . ."

Here is what the original paper's authors say, in their abstract:

. . .The de novo construction of a living organism is a compelling vision. Despite the astonishing technologies developed to modify living cells, building a functioning cell “from scratch” has yet to be accomplished.

The pursuit of this goal alone has -- and will -- yield scientific insights affecting fields as diverse as cell biology, biotechnology, medicine, and astrobiology. Multiple approaches have aimed to create biochemical systems manifesting common characteristics of life, such as compartmentalization, metabolism, and replication and the derived features, evolution, responsiveness to stimuli, and directed movement. Significant achievements in synthesizing each of these criteria have been made, individually and in limited combinations.

Here, we review these efforts, distinguish different approaches, and highlight bottlenecks in the current research. We look ahead at what work remains to be accomplished and propose a “roadmap” with key milestones to achieve the vision of building cells from molecular parts. . . .

What a time to be. . . alive. Smile. . . Forever Young came up just short.

नमस्ते

Now, Abbott Labs, A Second Tier Pharma... Has Spent About What Lilly Did, In Q1 2024, On Lobbyists.

In other years, I had compared Abbott to Baxter, but as Baxter retools and likely spins off or sells the Kidney Care business, it has dropped lobby spend to only about $320,000 in Q1 2024. So Lilly becomes a natural comparator to Abbott -- since Abbott spent a little more, and Lilly. . . a lot less, in Q1.

See at right, but here is what Abbott Labs lobbied about:

. . .S. 2477/H.R. 1770 Equitable Community Access to Pharmacist Services Act; S. 2922 Advancing Research for Chronic Pain Act of 2023; H.R. 2369 Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023; Proposals related to sterilization of medical devices; Proposals related to the President's Emergency Plan for AIDS Relief (PEPFAR); Proposals related to Department of Defense coverage of continuous glucose monitors; Proposals to advance policies related to effective pain management; Proposals related to future pandemic preparedness; Proposals related to the advancement, testing, and detection of Traumatic Brain Injury; Proposals related to the safe manufacturing of medical devices; Proposals related to the use of diagnostic tests in CLIA-waived settings. . . .

S. 1000/H.R. 1835 Saving Access to Laboratory Services Act; H.R.3674 Providing Relief and Stability for Medicare Patients Act of 2023; Proposals regarding PAMA regulations and changes to modernize and update the Clinical Laboratory Fee Schedule; Proposals related to Medicare coverage of continuous glucose monitors; Proposals related to outpatient coverage of cardiovascular medical devices. . . .

Proposals related to U.S. global health programs and pandemic preparedness; Proposals to advance global virus surveillance; Proposals related to preserving critical medical supply chains; Proposals regarding infant and child nutrition marketing. . . .

Proposals related to access to infant formula. . . . [This is spending related to a very old (since 1950s) legacy Abbott brand (Ross Labs). . . .]

Now you know -- And. . . . my exacta box bet is now down, at Churchill Downs -- let's see how they all break!

नमस्ते

Actually, This Past Quarter, Lilly Spent Even Less Than Merck -- Lobbying (Despite The Insulin Pricing Battle In Congress)...

Part Two, of the likely five part series on Q1 2024 Lobby-Spend trends, now appears for "Fourth Be With You" day. . . .

Lilly has worked diligently since about mid-2021, to lobby Congress to preserve its right to price the later-gen insulin products (and very aggressively -- on the weight loss ones). . . in any manner it likes, in the US. Some of that has succeeded -- some hasn't. And true enough, all the majors spend less during a presidential election year, as Congress is not likely to move major new initiatives, on either side of the coin during 2024.

Even so, Lilly (and to a lesser degree, Merck) are spending far less than would have been expected, here in Q1 2024. [We gave you some granularity on Rahway on Wednesday, here.] This is what Lilly was working to bend Congressional ears on:

. . .Issues related to intellectual property protection and market access within current trade negotiations. Canada IP; USMCA implementation; Mexico patent linkage; Special 301; Trade talks: US-Japan, US-China, US-EU, US-UK, US-India, and US-Brazil. . . .

Patient protection; Pharmaceutical supply chain issues and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the "Inflation Reduction Act" (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act; Policy matters related to Artificial Intelligence in health care. . . .

Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement, coverage and value; Implementation of the "Inflation Reduction Act" (HR.5376); CMS National Coverage Determination on Alzheimer's disease; The INSULIN Act. . . .

Multi-lateral threats to IP and the biopharmaceutical industry; Drug importation; Prescription drug value and access. . . .

Pharmaceutical intellectual property issues. . . .

Implementation of the Tax Cuts and Jobs Act; Domestic manufacturing tax incentives; Expensing of research and development costs; Global minimum tax; Pension and retirement benefit issues. . . .

Hospital discounts; 340B program. . . .

Now you know -- but clearly patent evergreening is top of mind, for insulin products at Lilly, in Carmel, Indiana. Smile -- now let's see that Japanese champ come in No. One, or No. Two -- as an exacta box, with Fierceness? Forever Young!

नमस्ते

ESA Offers Some Gorgeous Solar Coronal Mass Ejection Video Footage -- And... Run For The Roses Day, Tomorrow...

Without any more intro then -- from our friends on the Continent:

So, do take a look; it is only about 45 seconds long. . . .



Onward, looking for "Forever Young" to have a big day tomorrow. . . smile, and may the fourth be with you, all.

नमस्ते

Genuine Question: Should We Infer An Anti-Competitive Motive, When A Needed Vaccine For ~80,000 Oncology Patients Remains Subject To Stock-Outs, For... A Decade? [Cough. Merck.]

We've followed this for well-over eight long years -- the odd little vaccine that is part of certain bladder cancer treatments, as a first line (for up to 80,000 patients a year in the US). But the stuff has been supply-constrained. . . for the better part of a decade (how is that even. . . possible?).

Rather than offer wild-eyed conjecture at the head, I'll simply encourage the readership to read all of Fierce's very well thought out, longish update, on the state of the play, in the US at least:

. . .BCG, originally developed as a tuberculosis vaccine, is also a standard treatment for NMIBC, which accounts for about 80% of around 80,000 new bladder cancer diagnoses each year in the U.S.

The FDA has cleared Anktiva and BCG to treat patients with BCG-unresponsive NMIBC with carcinoma in situ. And ImmunityBio is evaluating the combo in BCG-unresponsive NMIBC with papillary tumors and perhaps more importantly in BCG-naïve NMIBC.

In the current indication, ImmunityBio will go toe to toe with Merck & Co.’s PD-1 megablockbuster Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin, both of which are administered by themselves without BCG. Ironically, Merck is currently the sole supplier of BCG in the U.S. . . .

Merck’s TICE BCG has been the lone BCG product in the U.S. since 2012, coming after Sanofi and another drugmaker ran into manufacturing problems. Sanofi officially pulled out of the market in 2016. Merck, which had before then not been the major supplier globally for BCG, was forced to pick up the slack. . . .

Now, were I a cynical sort of gent, and were we living in a prior epoch (prior to the required negotiated drug-pricing executive orders) I might have suggested that Merck historically (by designed indifference) kept a shorted- / shortish-supply chain on BCG to make other competitors' efforts at using it -- in more-lucrative oncology settings, as a combo therapy. . . more difficult. Note that Rahway claims (at least) that you presently can't get larger delivery quantities unless you've been ordering larger quantities since 2012 or so. [Yes, this is why I posted (again) on Mr. Shkreli immediately prior here.]

That all would have the effect of more or less "locking supplies in place", and keeping upstarts largely off the field in the US. In the EU, Japan and UK. . . that would likely be frowned upon, and may even violate the EU Competition Commission's rules. So, we will keep an eye on it. [It is not too great a stretch to say that Martin Shkreli nakedly did this, with Daraprim -- and thus earned a life-time FTC pharma industry ban. . . while, when much the same is accomplished. . . politely, with kid gloved large manufacturing facility cap ex, over a period of a half-decade, it is permissible in the US at least.]

नमस्ते

Tangent: Hopefully My Last Mention -- Of Martin Shkreli's "Troubles" -- In Relaunching Some *.inu Token, Here In 2024...

I elsewhere mentioned that Mr. Shkreli was apparently calling out what he regarded as other scammers, about token air-drops related to some AI project, over the past weekend.

Now it seems he's saying that "a kid he met in prison" has scammed him, by the use. of. HIS. good. name(?). . . .

Erm. Okaaaaaay.

I'll link this bit, because in it, Martin Shkreli's x-itter feed is reportedly making multiple verifiable, factual statements -- about the (now scrubbed) launch of. . . whatever this was going to be. And those better all turn out to be true, for Martin's sake (in avoiding a second stay at FCI Allenwood Low).

Here's the full story, out this morning -- and a bit:

. . .The recipient of the gift, who goes by @_d3f4ult on X, allegedly dumped his coins while promoting the unreleased token to his Discord group, telling them he was bullish and buying into Martin Shkreli's project.

Influential financial X account, Zerohedge, posted its take on the drama saying "Maybe don’t start crypto ventures with people you meet in prison?"

Whether legal action comes out of the alleged pump and dump is currently unknown, but it does add an example for cryptocurrency skeptics convinced the industry is full of fraud. . . .

For what it is worth, this is much the same narrative we heard in the late Summer of 2022: that some unknown someone had gained access to Martin's computer and crypto-keys, and rug-pulled the then Shkreli.inu. netting around $320,000.

That 2022 money is likely gone -- and it would not be shocking to learn that the "kid he met in prison" doesn't exist at all. . . and that it is all just another alt account of Mr. Shkreli's, himself.

Obviously, if the kid is real -- Martin could ID him to authorities, and they might pursue that guy for wire fraud (just as it did against Martin, in 2017-18!), and get at least some of the defrauded "investors' funds" returned.

But if these latest funds have gone offshore, to Swiss accounts, via Mr. Shkreli's other affiliated / alias accounts. . . that false-ID Will be useless (and another felony violation). Mr. Shkreli's federal BoP minders should require, at a minimum, given that he's made these affirmative factual statements in public, that he cooperate with law enforcement, and ID the supposed kid.

That would be / already is. . . a term of the order setting his continuing now two years of close monitoring.

Onward.

नमस्ते

The Merck Lanham Act Name Spat Case Has Been Reassigned To A New Jersey Federal Judge: Hon. Jamel K. Semper

And so, the trial date could possibly be moved forward -- into late 2024, given the less-crowded calendar of USDC Judge Semper. He was only installed as a federal judge in December of 2023. [Judge Semper was nominated by President Biden.]

He is certainly capable of doing the job. And this, too (a trial date arriving on swift wings) may hasten a settlement in this potentially multi-billion dollar case.

. . .TEXT ORDER REASSIGNING CASE. Case reassigned to Judge Jamel K. Semper for all further proceedings. Judge Esther Salas no longer assigned to case. So Ordered by Chief Judge Renee Marie Bumb on 4/30/24. . . .

[Ed. note: Wikipedia has his CV down thus] ". . .Semper received a BA from Hampton in 2003 and was an honors student at Rutgers Law School in 2007. Upon passing the bar, Semper served as a law clerk for Judge Harold Fullilove of the Essex County Superior Court from 2007 to 2008. From 2008 to 2013 he served as an assistant prosecutor in the Union County Prosecutor's Office and from 2013 to 2018 he served as an assistant prosecutor in the Essex County Prosecutor's Office.

From 2018 to 2023, he served as an assistant United States attorney in the U.S. Attorney's Office for the District of New Jersey, where he served as deputy chief of the Office's Criminal Division. During his time as an Assistant U.S. Attorney, Semper headed the Organized Crimes and Gangs section. In 2021, Semper was one of seven candidates under consideration to be the United States attorney for the District of New Jersey. . . ."

Now you know. And okay -- I cannot resist a lil' snark.

Call me crazy, but I do not imagine that Tangerine would have ever considered his name. This, even though he is clearly pro-law enforcement (a claim Tangerine always makes -- even as he himself commits a seemingly endless string of. . . felonies). Onward, grinning -- ear to ear.

नमस्ते

The Curious Story Of... ECMO, And Access Questions In ICUs, Inside The US.

This is not -- in any sense -- any new therapeutic option, but in fact one that dates (brace yourself) to. . . 1932. It historically has been rather-sparingly used, as a bridge to lung transplantation -- because it does (in some ways) represent the blurring of a line -- a line, between what it means to be alive, as opposed to. . . dead.

I'll tease no more of it -- but just link it, and encourage the readership to go parse it all. Here's that finely-written long-form New Yorker story -- and a bit:

. . .[In a fashion photo-shoot of a 23 year old woman, each image shows, in the background] a metal trolley stacked with medical equipment. Two large plastic tubes, one cherry red, the other dark plum, loop from the trolley to Arms, entering her body beneath her clavicle. She has cystic fibrosis, a condition that damages the lungs. Hers are failing, and the machine on the trolley has replaced them. . . .

But some physicians worry that ECMO is creating entirely new ethical conundrums. “The unfortunate reality is that, sometimes, people get put on this machine and they don’t get better,” Jessica Zitter, a palliative- and critical-care physician, told me. A patient whose heart has stopped could potentially live on the machine for months, awake, able to walk and read the newspaper. But he might never leave the I.C.U. “It’s a trap,” Zitter said.

ECMO is transforming medical care, saving lives. But it also complicates care when life inevitably begins to end, committing some patients to a liminal state with no hope for recovery. When should it be used, or withheld? And who should decide?. . . .

Indeed -- who will make these calls / decisions? How old is. . . too old to be a suitable candidate? How sickly. . . is too sickly. . . to be placed into the bridge -- we will keep an eye on this topic.

With that said, I suppose it is an essentially happy problem to have -- if it means that there are options, for at least some of the more desperately, deeply-obstructed lung patients -- in the major city hospitals around the nation. Your mileage may vary. . . in fact, it probably. . . does.

नमस्ते

More To Come, Shortly -- On The Others, But Merck Has Been Very Judicious In Its Q1 2024 Lobby Spending...

And that is true, when compared to peers -- as well as to the prior year's Q1 spend. Q1 2023 spend figures are in half tone grays at right.

It seems only Amazon is still spending heavily, on its Congressional jaw-boning -- even in this Presidential election cycle year. [But that is likely to try to blunt any new legislation aiding the wins the Amazon Labor Union has secured, for the about 1.2 million workers at Amazon, and affiliates.]

As I say, more to come -- on the others -- but here is at least some of what Merck was lobbying on early this year:

. . .H.R. 3, (117th Cong.) Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19, (117th Cong.) Lower Costs, More Cures Act of 2021; H.R. 830, Help Ensure Lower Patient (HELP) Copays Act; H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023; H.R. 2679, Pharmacy Benefits Manager Accountability Act; H.R. 2691, Transparent Prices Required to Inform Consumer and Employers (Transparent PRICE) Act; H.R. 2816, Pharmacy Benefit Manager; Sunshine and Accountability Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act (PASTEUR) Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. . . .

H.R. 3285, Fairness for Patient Medications Act; H.R. 3633, PREVENT HPV Cancers Act of 2023; H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024; H.R. 4895, Lowering Drug Costs for American Families Act; H.R. 5376/S. 2474, Share the Savings with Seniors Act; H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 7174, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; H.R. 7635, The 340B PATIENTS Act of 2024; S. 150, Affordable Prescriptions for Patients Act of 2023; S. 1339, Pharmacy Benefit Manager Reform Act; S. 1895 (116th Congress) Lower Health Care Costs Act; S. 2333, Pandemic and All-Hazards Preparedness and Response Act; S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019. . . .

Issues relating to 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Anti-microbial Resistance; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccines issues; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; Issues related to the Patent and Trademark Law Amendments Act (PL 96-517); FY-2024 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; WTO IP Waiver for COVID therapeutics. . . .

Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: ADUFA & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Farm Bill 2023; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms. . . .

Now you know. Onward -- for a mountain bike ride, in the warm Spring air. . . smile.

नमस्ते

Some Good News -- But Again, Largely Immaterial.

[This is just a short Thursday filler-post, with the immortal beloved Jedis to arrive shortly. . . then the Revenge of the Sixth. Grin -- with tacos for Cinco in between.]

Merck saw very encouraging first line results in HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma -- via KEYNOTE-811. Here's that bit:

. . .[Merck announced that] the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy met its dual primary endpoint of overall survival (OS) for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. . . .

Onward, the pembrolizumab juggernaut rolls. We will try to get some Q1 '24 updated lobby disclosures out before "The Fourth Be With You". . . smile.

नमस्ते

May 1 UPDATE: Amazon / NLRB Wrangling Update, Related To AMZN / JFK-8 Lawless Union Busting Tactics...

Here is our monthly check in, to highlight the NLRB staff counsel's very cogent brief in defending a post decision ruling, out of Phoenix, against Bezos' serial labor relations violator, called Amazon.

Here, the staff counsel argues that seizing union literature, and destroying it cannot be re-cast as permissible "tidying up" of the lunchrooms, because the VIDEOTAPE shows security guards stealing only the union pamphlets and posters, and leaving garbage on the tables. . . untouched. Charming, thus:

. . .Spence then returned to the breakroom and saw [Security Guard] Hill holding copies of the Notice that Spence had distributed. See Tr. 543:7-12. Spence approached Hill and asked Hill why he removed the papers from the tables. See Tr. 1064:12. Spence told Hill that the papers concerned a union. See Tr. 1064:12-14. Spence further said that Hill didn’t “work for Amazon,” and that it’s not Hill’s “job to break the law.” Tr. 543:13-17. Approximately 20 Amazon associates were present in the breakroom at the time. . . .

[Security Guard] Koplevich took photographs of ALU activity taking place at a public bus stop adjacent to JFK8. See Tr. 1067:10-18, 1081:19-21. Troy immediately asked Bertone to have Metro One remove Koplevich from JFK8 because she was acting outside of her authority, as Metro One guards are only allowed to take photographs or make videos during an active investigation. . . .

There is much more at this link. But truly, the union will keep its win -- on that you may rely. Onward.

नमस्ते

[Huge Revenue Miss!] Tangent: Bitcoin Drops Below $57,000 Overnight, In Asia On Macro Fears — Riot’s Results A Drag, As Well…

Perfect storm a-comin’, for Riot when NASDAQ opens. Fear abounds in crypto as US fed decision day arrives.

Will update at 8:30 am Eastern, when Riot’s losses for Q1 ‘24 are disclosed.

Will be… It is flashing carnage -- a $9 something handle, at open.

Updated @ 8:30 am: Riot was expected to post revenues of around $93 million for the quarter; even BEFORE Halvening, it has only generated about $79 million in revenue. A huge miss. [More detail when the actual 10-Q is filed.]

And though it nominally showed net earnings, all of that plus more was due to a recent change in accounting methods -- one in which it is allowed to inflate "income" / reduce expenses in periods of rising Bitcoin prices, even when it is only a paper gain (Riot got zero proceeds from the Q1 increases); and it will show ballooning expenses, in periods when Bitcoin is declining. Like now.

If it were not allowed to count the paper gains, Riot would have had net losses of around $22 million.

What a train wreck. The entire value of the business is driven by whether Bitcoin can stay above about $50,000 in Q2. Thus far, it has fallen from a high of around $73,400 to $56,900 as I write this, in Q2. Losses will be shown in Q2 if this persists.

INSANE -- all while paying top executives ~$23 million in the quarter. Damn.

Out.

नमस्ते

Tangent: The Supremes Tell Musk... "Tell Your Story Walkin', Bub..."

Welp. This has turned out just as we said it would. When you lead a public company, and take the public's funding -- you are subject to certain very sensible duties -- like not lying -- about your stock.

Mr. Musk got off very easily after 2018-era tweets that misled the public, and his shareholders, about Tesla stock. In his settled action with the SEC Enforcement staffers, he agreed to do certain things, to avoid a worse outcome. Specifically, he agreed to a $20 million fine for making misleading tweets, related to his '34 Act registered stock -- and agreed to have his GC pre-approve all tweets that mentioned his stock.

Then, several years later, he tried to argue that his own agreement violated his free expression rights. Hilarious.

What a churlish cad.

He AGREED, in writing (while being advised by some of the best lawyers in the US) -- all to avoid a loss at trial (and an order removing him as an officer, director or any other role of power at Tesla); with hundreds of millions of dollars in fines possible (he had lied about a potential multi-billion Dollar buyout offer) -- and even a chance of jail time (sorta' like Martin Shkreli).

After losing on appeal in the Second Circuit, the Supremes. . . laughed at his petition for cert., thus:

. . .Musk's settlement resolved the SEC lawsuit accusing him of defrauding investors. Under the agreement, Musk and Tesla each paid $20 million fines and he gave up his role as the company's chairman. Musk also agreed to let a Tesla lawyer pre-approve some posts he made on the social media platform then called Twitter before Musk bought the company and renamed it X.

Musk later sought to terminate the pre-approval mandate, with his lawyers in a court filing calling it a "government-imposed muzzle" that amounted to an illegal prior restraint on his speech. . . .

Now you know. This chucklehead. . . geez.

[More recently, he's been spouting whyte replacement paranoia themes / crazy conspiracy theories -- on his cash burning platform I call X-itter. Not exactly the kind of expression that we all should be rushing to protect, overall -- as it often strays very close to intentional hate crimes, against protected classes.]

Onward.

नमस्ते

Of "Vampire Facials"... That End Up Being... Debilitating, Life Long Medical Problems.

It has been a minute since I put up an "unlicensed, unapproved" medicines post.

But this one. . . is so egregious, it rivals Jim Bakker's colloidial-silver solution being sold on cable-TV as "a cure" -- for COVID-19 -- back in 2020. Despicable.

In this current case, at least three women have tested positive for HIV, the virus that causes AIDS, apparently after being micro-needled, in a "vampire facial" from an unlicensed supposed med-spa, in New Mexico. Understandably, the owner is facing jail time. Here's a bit, from NPR:

. . .Many popular cosmetic treatments are delivered with needles, such as Botox to iron out wrinkles and fillers to plump lips. A "vampire facial," or platelet-rich plasma microneedling procedure, involves drawing a client's own blood, separating its components, then using tiny needles to inject plasma into the face to rejuvenate the skin. . . .

The New Mexico Department of Health began investigating the spa in the summer of 2018 after it was notified that a woman in her 40s had tested positive for HIV even though she had no known risk factors. The woman reported exposure to needles through the procedure at the clinic that spring.

The spa closed in fall 2018 after the investigation was launched, and its owner was prosecuted for practicing medicine without a license. . . .

The idea that a "lip plumper" (or similar) treatment could / would lead to AIDS. . .? Damn. Just. . . Damn. Be careful out there. Always -- always, demand to see every license, on paper before sitting down. Out.

नमस्ते

Anon. Points Us To The Layoff News At BMS -- As Its Keytruda® (Pembrolizumab) Competitor, Called Opdivo®, Saw Declining Sales Last Year, And In Q1 2024...

From about mid-2014 to late-2017, the immuno oncology "horse race" was on, between Merck's bio-engineered PD-1 inhibitor (branded as Keytruda) and BMS's. . . theirs being called Opdivo. We covered it with at least 100 posts in that time frame. [Search the upper left dialog box if you'd like some background, from our perspective -- here. And, Merck has hit the $22 billion a year mark a year ahead of Wall Street's estimates -- here in 2024, not 2025.]

But as the markets matured in immuno-oncology, in the main, Rahway's has shown stronger statistically better (longer term) survival data than BMS's agent has. [In the US, it is difficult to get full reimbursement for a "second best" agent, with a winner already available, in many solid organ tumors.] And so -- as of last Thursday, Bristol Myers Squibb began retrenching, thus:

. . .Bristol Myers Squibb on Thursday said that around 2200 staff will be impacted by cost-cutting measures designed to save about $1.5 billion by the end of 2025, with two-thirds of the savings coming from R&D. The initiative will reduce management layers in an effort to speed decision making, along with pipeline rationalisation and site consolidation. . . .

However, revenue from Opdivo fell 6% to $2.1 billion.

Chief commercialisation officer Adam Lenkowsky explained that the PD-1 inhibitor was hit by changes in buying patterns in the US, but the company is "confident we will see accelerating growth this year. . . ."

I would not bet on many more high growth quarters for BMS's Opdivo -- Keytruda has become the gold standard choice here (especially inside the US). So we extend our best meditations, to the families of the 2,200 BMS people being let go. Onward -- now you know.

नमस्ते

It Seems Dark Energy -- Universe-Wide -- Is... "Thawing?" That Is, It Seems To Be... Waning.

As ever, first -- the caveats: the data is strong, but the universe is very vary large. Very large. So over billions of light years, small differences in measured assumptions. . . can become magnified. That is, it could be a measurement error. [But two independent sources are now converging on this, as being real, and not an artifact.]

Moreover, this is approaching five sigma, nearly a gold standard for significance. More to come, of course -- but the notion is that maybe the universe is a closed system -- an endless series of big bangs and big collapses. [In a poetic/metaphorical sense sense, confirming endless "reincarnations" of all that we will ever see.] That we are not flying apart, never to fall back in, to a center.

Here's the latest, via Wired.com:

. . .If dark energy is weakening, it can’t be a cosmological constant. Instead, it may be the same sort of field that many cosmologists think sparked a moment of exponential expansion during the universe’s birth. This kind of “scalar field” could fill space with an amount of energy that looks constant at first—like the cosmological constant—but eventually starts to slip over time.

“The idea that dark energy is varying is very natural,” said Paul Steinhardt, a cosmologist at Princeton University. Otherwise, he continued, “it would be the only form of energy we know which is absolutely constant in space and time.”

But that variability would bring about a profound paradigm shift: We would not be living in a vacuum, which is defined as the lowest-energy state of the universe. Instead, we would inhabit an energized state that’s slowly sliding toward a true vacuum. “We’re used to thinking that we’re living in the vacuum,” Steinhardt said, “but no one promised you that.”

Joshua Frieman, a cosmologist at the University of Chicago and a member of the DESI collaboration who didn’t work on the data analysis, said he would be glad to see Lambda CDM fall. As a theorist, he proposed theories of thawing dark energy in the 1990s, and he more recently cofounded the Dark Energy Survey -- a project that searched for deviations from the standard model from 2013 to 2019 and created one of the three supernova catalogs DESI used. But he also remembers being burnt by disappearing cosmological anomalies in the past. “My reaction to this is to be intrigued,” but “until the errors get smaller, I’m not going to write my [Nobel] acceptance speech,” Frieman joked. . . .

The beauty of all this is that Einstein (were he alive) would celebrate wildly, if the next-gen data refutes his "constant" definitively. He always said that we learn the most when our best presumptions turn out to be. . . in error. Onward, grinning into a busy week ahead.

नमस्ते

As In June Of 2021, Hubble's Third Gyroscope Is Rendering Inconsistent Readings -- Hubble May Go To A One Gyro- Slew Configuration...

This 'scope has been in service since 1990 -- and last had six gyros installed in 2009, by the then space shuttle "capture / repair" missions. So it has had a wonderful ride. . . but is, indeed a very old spacecraft.

With the next-gen space scope (JWST) operating flawlessly, and providing far sharper imagery. . . it may be, that in due course, this one is allowed to safely deorbit. But for now, science will continue (once the fix is applied, ground-side) -- even if need be, on one gyroscope. Here's the latest:

. . .The telescope automatically entered safe mode when one of its three gyroscopes gave faulty readings. The gyros measure the telescope’s turn rates and are part of the system that determines which direction the telescope is pointed. While in safe mode, science operations are suspended, and the telescope waits for new directions from the ground.

This particular gyro caused Hubble to enter safe mode in November after returning similar faulty readings. The team is currently working to identify potential solutions. If necessary, the spacecraft can be re-configured to operate with only one gyro, with the other remaining gyro placed in reserve. The spacecraft had six new gyros installed during the fifth and final space shuttle servicing mission in 2009. To date, three of those gyros remain operational, including the gyro currently experiencing fluctuations. Hubble uses three gyros to maximize efficiency, but could continue to make science observations with only one gyro if required. . . .

Now you know. . . onward, grinning, with a legacy graphic -- and baby girls due here this evening.

नमस्ते

The River Buoy / Razor Wire Barriers Will Be Removed, But USDC Judge Ezra Ruled That The Treaty Is Not "Self-Executing".

This is a small update -- as Judge Ezra has also ruled that all of the federal government Rivers and Harbors Act claims, and the immigration laws which vest singular authority at the federal level for border matters. . . remain intact.

And Texas has (as we've explained, ad nauseum) already lost -- on those. [Texas has appealed those losses, and it is all on appeal, and fully-briefed in the Fifth Circuit, with arguments due in June.]

All he held here, in 41 pages, published overnight, it that the Supremacy Clause by itself, cannot make the Treaty of Hidalgo from the 1840s self-executing, as against an individual state in the union.

So -- a minor matter, as I say. Onward, grinning.

नमस्ते

Just A Little More Color, On One Franchise That Will Begin "The Backfilling" -- In The 2030s, As Pembrolizumab Begins To Lose Exclusivity, Then: Winrevair®

To be clear, Keytruda^® will roll on, with global revenues increasing about 20% per year. . . into the early 2030s. That's a huge competitive advantage -- lapping the field, year after year. But should unforeseen patent trouble arise (in the form of a Congressional move, to more forcefully limit patent evergreening) -- it will be products like winreviar, that keep Merck chugging along like the cash flow juggernaut it is.

It was indeed an excellent Q1 2024, and the NYSE-traded stock should reach into the $140-something range -- perhaps even before year end 2024 -- as the amped up guidance offered by Mr. Davis yesterday appears in the as actually-reported results next quarter and beyond. Here's that story, from FiercePharma, as part of its review of Rawway's first quarter 2024 "upside surprise" results:

. . .Four months into Davis’ tenure as CEO in 2021, the company acquired sotatercept in an $11.5 billion buyout of Acceleron. Data analytics group FactSet has projected sales of Winrevair to reach $3.9 billion by 2029.

“Strategic business development focused on the best external science remains an important priority,” the CEO said. . . .

When asked to estimate Winrevair’s sales this year, Davis reiterated that the company does not provide guidance for its individual products. He did declare that the launch is off to a strong start, with prescriptions increasing along with repeat prescriptions. Shipments to patients’ homes is underway. And the company is seeing excellent access with “no real limits,” Davis said, which is a good sign considering the drug was approved less than a month ago, he added.

R&D chief Dean Li, M.D., Ph.D., said that there will be continued “data flows that will continue to inform and strengthen,” Winrevair’s profile. The company also is working on an auto-injector that should improve uptake for the drug, which is currently provided in a vial.

“We believe that the vast majority with time will use it as self-administration,” Li said. “This is a patient population that’s quite used to doing injections. . . .”

I continue to believe that $250,000 a year -- even though it is a life saver. . . is overpriced, for most US retail patients -- as that means Merck makes back all $11 billion it paid for the whole company, in about five years.

The drug will remain on patent for over 20 years. The Condor's view is that moves like that, indeed, are likely going to lead to more Congressional action to restrict US-drug pricing -- or incentivize the company to more sharply increase EU and/or Canadian and Japanese prices -- to allow the US prices to come down. . . between now and 2028, on all life-saving pharmaceuticals, generally.

[We've already seen one version of this (as we mentioned last week), with Merck allocating more supply of Gardasil to EU and Japan and UK -- while shorting its contractual commits -- to WHO/GAVI/UNICEF -- for very low priced African deliveries, in this supply constrained year.]

नमस्ते