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Moderna Makes Full Study Protocol Document Public; Reports 25,000 Enrolled In Phase III Clinical Trial…

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This is offered in our continuing efforts to counteract the false — and potentially lethal — mis-information spread by Hinderaker and Mirengoff (who are simply echoing Trump’s generally lunatic ravings, on the topic of vaccine science). This is truly encouraging — both for its transparency, and for the non-hyped, “solid science only” reporting on the mRNA vaccine candidate’s progress. [In addition, a short “plain English” video has been made available — see it at the bottom of this post.]

Here’s a bit — and here is the full study protocol, as a 120 page PDF file — but do read everything, in the full press kit — if you want to be fully-informed:

…COVID-19 vaccine (mRNA-1273):

As of Wednesday, September 16, 2020, 25,296 participants have been enrolled in the Phase 3 COVE study and approximately 28% of participants enrolled cumulatively are from diverse communities. 10,025 participants have received their second vaccination. The protocol for the study being conducted in collaboration with the NIH and BARDA is now publicly available. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study evaluating a two-dose vaccination schedule of mRNA-1273 across three dose levels (25, 100, 250 µg) in 45 healthy adults ages 18-55 years was published in The New England Journal of Medicine and shows mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.

mRNA-1273 was generally safe and well tolerated with no SAEs reported through Day 57. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of mRNA-1273 with federal funding under Contract no. 75A50120C00034….

[Note specifically that no projected FDA approval date is mentioned.] As I say — this is how to build public confidence — in a novel vaccine. Not fantastically-preposterous bluster — from a Tangerine-hued, would be Mussolini.

नमस्ते

Lady A: A Tale Of Two Rivers — And Two Artists — With Only One Real Name: Nashville vs. Seattle Edition

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Earlier today, in Nashville, the REAL Lady A moved to dismiss the Antebellum complaint for declaratory relief — on the grounds that the filing was a sham, all meant primarily to deprive her of the right of choosing venue and forum. She’s right.

Of more direct moment, though — just yesterday, she also smartly filed her own complaint in federal court in Seattle, her “home court” territory, alleging infringement of her prior, superior, common law marks, by Antebellum — since that national country act has certainly played concerts in Washington State over the years (and so, she can get them, there, for…) selling tee-shirts, with an abbreviation on them.

Condor predicts she will be able to fix the venue in Seattle, Washington, and the Nashville, Tennessee federal action is likely to be dismissed, or transferred over, to Seattle. Here’s a bit of the substance of her well-pleaded claims — but do go read it all:

. . . .In the days that followed, Ms. White came to believe that the agreement being negotiated by her original pro bono counsel was not in her best interests. Specifically, the agreement would have allowed Lady Antebellum to continue using the LADY A while providing no compensation to Ms. White — only the promise that Lady Antebellum would make best efforts to assist her career and up to $10,000 reimbursement for legal fees associated with negotiating a resolution of the parties’ dispute (notwithstanding the fact that Ms. White was represented pro bono) and trademark filings for Ms. White’s LADY A mark….

Ms. White retained new pro bono counsel at Cooley LLP, whom promptly attempted to resume negotiations with Lady Antebellum with the aim of protecting the LADY A brand established by Ms. White. To that end, Ms. White’s new pro bono counsel shared a draft settlement agreement with Lady Antebellum on July 6, 2020.

Instead of responding to the offer, and without warning, Defendants filed a declaratory judgment action against Ms. White in the Middle District of Tennessee on July 8, 2020 (the “DJ Complaint”)….

In the DJ Complaint, Lady Antebellum alleges that they have used LADY A as a trademark for music related offerings since as early as 2008. Lady Antebellum further alleges that Defendant LAE is the owner of U.S. Registration Nos. 4,004,006, 4,030,752, and 4,292,685 for LADY A. According to Lady Antebellum, the parties’ LADY A marks can coexist, notwithstanding the fact that they are identical, are used in connection with the same goods and services, and are rendered through the same channels of trade….

To the contrary, on information and belief, prior to June 2020, Defendants did not perform as LADY A and did not make use of the fan-originated “LADY A” nickname as a trademark….

On information and belief, even if Defendants had used LADY A as a trademark, Ms. White possesses superior common law trademark rights, which precede the existence of Defendants’ band, let alone their alleged LADY A mark. To the extent that any prior coexistence occurred, it was only because Defendants’ use was limited, lacked prominence, and would have been overshadowed by the well-known LADY ANTEBELLUM mark….

Onward… justice will eventually… flow like a river, here — now, just not from the Cumberland basin. It will come on silvery shying disks, in the luminous dawn, to Anita White — from the grace-filled curves of the… Duwamish, winding to the south easily out… of Seattle. Smile — now you know.

नमस्ते

[O/T, 2] Perhaps We Should “Be More Slowly… Deliberative” — As We Approach Studying The Potential Signs Of Microbial Life In The High Amber Clouds, On Venus

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Last year, in early August of 2019, we both reported on — and editorialized / discussed — the manifold problems a privatized Israeli lander’s crash may have caused, as to contaminating the Moon, with hardy Earth based life, onboard the Israeli craft — besmirching… that otherwise pale, and sterile orb (our nearest neighbor — see small image below, right).

Quite rightly, at least a few astro-biologists are suggesting that purely privatized missions to Venus, in search of a Venusian microbe or two… perhaps ought to be curtailed — mostly to protect the purity of whatever it is that is generating the excess phosphine there.

Given our collective histories, with Earth-based, private “land rush” operations, in the 12th through 19th centuries — and here I refer primarily to peoples of Western European (and US) origin — I think it wise to be circumspect about who, and what — will be allowed to aim to pierce the Venusian cloud tops, before NASA gets there in 2026.

Here it is, from Slate, last night. Do read it all — but here is a bit:

…One potential solution to this new chemical mystery on Venus is to immediately pour efforts into going there, leading to a near-future “Venus Rush.” But much like other moments in history where we have rushed forth, humans have the ability to curtail possible futures, and to create great harm, when we rush. . . .

Planetary protection isn’t just cleaning a spacecraft; it is born out of a philosophy for how we can ethically engage with other worlds. At least in my case, I am hopeful — both for phosphine and for a future where we have deeply considered ethical frameworks for exploration. In the meantime, excitement and anxiety will always go hand in hand….

Onward… and so speaking, this evening, we’re in need of good thoughts, for my own mother… sadly. Anxiety, indeed, now over a multiple broken bones fall, overnight. Keep a good thought… that’s what I’ll do.

नमस्ते

More Racism, From Paul M. — On US Youth COVID-19 Mortality Rates…

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Paul decided it wasn’t enough to FALSELY just imply… that poor genes… are the key factor in why more children of color are dying of COVID-19, than white kids.

No — he felt compelled — without even a shred of evidence, to support his prejudice — to outright attempt (again falsely) to blame kids’ COVID deaths on their parents’ (supposed) bad behavior:

“…Might comparatively reckless behavior by parents of minority youths and and minority teenagers have something to do with the disparities?….”

Nice overt racism, there Paul.

The sublime irony of it all is… that he might have been right, if the deaths were skewing more heavily to white kids, than brown ones… proportionately — since it is almost uniformly the white parents (a/k/a the bears of little brains) we all see in our daily TikTok feeds, getting angry and refusing to mask up — or partying on Harleys, cheek and jowel, in the Dakotas… or boating in a viral Petri dish soup/bath, at the Lake of The Ozarks… or… attending Trump Klan-demics in Tulsa, Nevada and the Carolinas.

As it is, he is wholly unwilling to admit that poorer health care (via lower income levels), and reduced access to healthy nutrition sources, in the manifold urban “food deserts” which dot the nation (from decades of dis-investment — by society at large)… might be more important factors. In fact, he mocks the Wa Po for the data it collected on that notion.

So, to sum up… Paul M. is… an ass.

Literally… Unprecedented: For The Very First Time, In 175 Years — Scientific American Magazine…

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This immensely sensible (perhaps… dowdy, even) journal — one that was likely on your father’s and mother’s night-stand or coffee table — just felt compelled to endorse a US Presidential candidate. In fairness, the august periodical did so primarily to repudiate Trump’s lethal unwillingness / inability to… science, even when it would save registered voters’ lives.

Below, and at right are testaments to that idea. But Mr. Biden will allow science to guide his governing. Of that much we may be certain. So, it is… that one cannot be for Trump, and for real science (do go read it all!) — the two are obviously… in opposition:

…Trump repeatedly lied to the public about the deadly threat of the disease, saying it was not a serious concern and “this is like a flu​” when he knew it was more lethal and highly transmissible, according to his taped statements to journalist Bob Woodward. His lies encouraged people to engage in risky behavior, spreading the virus further, and have driven wedges between Americans who take the threat seriously and those who believe Trump’s falsehoods. The White House even produced a memo attacking the expertise of the nation’s leading infectious disease physician, Anthony Fauci, in a despicable attempt to sow further distrust.

Trump’s reaction to America’s worst public health crisis in a century has been to say “I don’t take responsibility at all.” Instead he blamed other countries and his White House predecessor, who left office three years before the pandemic began….

[On the other hand,] Mr. Biden is getting advice on these public health issues from a group that includes David Kessler, epidemiologist, pediatrician and former U.S. Food and Drug Administration chief; Rebecca Katz, immunologist and global health security specialist at Georgetown University; and Ezekiel Emanuel, bioethicist at the University of Pennsylvania. It does not include physicians who believe in aliens and debunked virus therapies, one of whom Trump has called “very respected” and “spectacular.”

Biden has a family and caregiving initiative, recognizing this as key to a sustained public health and economic recovery. His plans include increased salaries for child care workers and construction of new facilities for children because the inability to afford quality care keeps workers out of the economy and places enormous strains on families….

Steve H. Thinks this is comical. He would, as he is no serious… anything, in point of fact.

Again. These. Are. Truly. Unprecedented. Times. And they are (hopefully never to repeat again, in our 240 year history) on nearly every relevant dimension. Do go vote. Vote early. Safe travels to my finely-grown and brilliant youngest (and partner), now putting in 19 hours by car — to meet my eldest, in the land of the saguaro cacti — and thus get out of the burn zones, in Oregon… with their handsome pooch in tow, too… smile. This too… shall pass.

नमस्ते

Just Three Short Weeks Ago, Hinderaker Was Crowing About MN Going “Deep Red…” Hah!

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Interestingly, his now increasingly-disproven claim that “Minnesota’s BLM-led chaos” (his words) would help Trump carry the state in convincing fashion… is falling apart. Completely.

Two new polls have Trump losing by nearly ten points, in Minnesota.

But do keep selling this faux-lawlessness narrative, John. It does suit you; doom and gloom, and falsely-projecting it as being Mr. Biden’s future, rather than what it is: Mr. Trump’s present, and demonstrated past history — of dividing the nation, along racial lines, intentionally.

[Oh. And… BTW, John’s favorite would be hard right GOP challenger — to incumbent Tina Smith is also losing by ten points, i.e., not competitive, for that Democratic-held US House seat in Minnesota. Hilarious waste of John’s time, and his, and his benefactors’ and donors’… money there.]

Cheers, moron.

Injunction Now Likely, Out Of Oakland (But Enforceable, Nationwide) — Against Trump’s Work-Visas/Asylum Fee “Price Gouging” Attempts…

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Mr. Biden will end all this nonsense — come January 22, 2021. [Backgrounder, on this East Bay IV litigation, here.]

But until then… we collectively must oppose Trump, in the courts — to protect the taxpayers’ funds from… grifters like his family, and the increasingly narrow band of GOP major donors who still support him. Here’s the latest finely-reasoned 27 page brief, out of the Northern District of California — just filed, by people who still believe the US Constitution means what it says, and a bit:

…Defendants’ Opposition is packed with conclusory and internally inconsistent statements that do not answer the serious questions in Plaintiffs’ Motion for a Preliminary Injunction….

Defendants insist that Mr. McAleenan and Mr. Wolf had valid authority to serve as Acting Secretaries of the Department of Homeland Security (“DHS”). Opp. 3-4. But for that proposition, they point to an April 2019 Order issued by Kirstjen Nielsen that applies only in the event of “disaster or catastrophic emergency.” See ECF 69-1, 69-2. Defendants’ assertion that the Order also applies in the event of a resignation contradicts the Order’s plain language. Defendants’ other attempts to justify the Final Rule also fail….

Because the Final Rule suffers from fatal procedural and substantive flaws, it must be set aside under the Administrative Procedure Act (“APA”). Plaintiffs’ are likely to succeed on the merits and satisfy all other requirements for a preliminary injunction. The Court should grant Plaintiffs’ Motion….

And… so (likely) ends Trump’s bid to create yet another slush fund, from which he might illicitly reward his cronies, and major donors, by letting new no-bid federal construction contracts — ostensibly to build his vain little wall. But in fact, it is purely banal… grifting. And the courts… will shortly end it.

नमस्ते

Once, Is A Mistake (“Nyet”?); Twice Is Gross Incompetence… THREE Times… Is… Likely At Putin’s Direction.

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The image at right pretty much tells the whole story.

Maddow reported on it, last night — that’s how I came across it. Here’s that bit:

…Ruslan Pukhov, director of the Centre for Analysis of Strategies and Technologies in Moscow, confirmed that the planes are Russian MiG-29s, and also said the soldier on the far right in the ad carries an AK-style assault rifle….

Trump’s people ran this first, as a 9/11 “memorial”. It has run at least twice since then. It is hard to imagine how, had Mr. Obama tried any of these things — the then GOP would not have already impeached and removed him. [Of course, he’s an actual patriot, and a competent leader, with real organizational skills, and discipline, at that — so he would never do these awful things.] Here endeth the fourth grade civics lesson.

And perhaps saddest of all — we all know these sorts of plain influence, in the open (or at least, stunning incompetence, in his senior campaign creatives staff) won’t change a thing, for his “base.” They will say he is “trolling the libs“. I will say… my brothers’ buddies (in Vietnam) — to say nothing of my dad’s buddies, in Korea, or my grandad’s brothers (in Europe)… didn’t know they were sacrificing their very lives, on the fields of battle… for this… insanity.

नमस्ते

[O/T:] “Extraordinary Claims Require… Extraordinary Evidence” Dept.: Life On Venus? Maybe…

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It is not really very likely that this is a smoking gun signature of life — but there is too much phosphine in chemical signature traces taken over the amber clouds on Venus, to have been produced solely by volcanic activity.

Or, if it is volcanic, it implies that Venus sees over 200 times more volcanic-activity than Earth, per square mile. And, well… that seems pretty unlikely. So it is an increasingly tantalizing possibility — that this is the signature of rudimentary single cell life — in the amber clouds above that hot planet.

Even so, as Carl Sagan reminded us now almost 50 years ago — such an extraordinary claim, should come bearing equally extraordinary… evidence, in its favor. And I am not sure this qualifies, just yet. Here’s the latest from NPR:

…The researchers have racked their brains trying to understand why this toxic gas, phosphine, is there in such quantities, but they can’t think of any geologic or chemical explanation.

The mystery raises the astonishing possibility that Venus, the planet that comes closest to Earth as it whizzes around the sun, might have some kind of life flourishing more than 30 miles up in its yellow, hazy clouds.

Nothing could live on what passes for land on Venus; its smooth volcanic plains are a scorching hellscape hot enough to melt lead, where the temperatures exceed 800 degrees Fahrenheit. High in the clouds, however, the pressures and temperatures and acidity levels would be less intense — near room tempuratures, and Earth-like pressures….

All of which may mean NASA/JPL will get a green light for the funding to fly robotic atmosphere probe missions, to Venus around 2026. Smiling at the third level central visits, elsewhere this afternoon… grinning ear to ear in fact. Stay safe, all — near and far….

नमस्ते

[U] Still “Sound and Fury”… “Signifying… [Essentially] Nothing.” That’s Trump’s Drug Pricing “Order.”

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UPDATED @ 1 PM: The latest [non-] order expressly repeals the prior [non-] order, from July. This means any importation of prescription medicines from Canada is… officially dead. All of this means nothing positive. And it means all the goofy “maybe this” or “maybe that” cha-cha, from the July order no longer exists. PhRMA, for its part, had a week ago pointed out just how senseless, and internally contradictory all of Trump’s drug price non-“orders” have been. But here is that bit, from yesterday’s White House mush-mouth release (at Section 5):

“…The Executive Order of July 24, 2020 (Lowering Drug Prices by Putting America First), is revoked….”

It must be completely exhausting, as a pharma-lobbyist — to try to keep up — as Trump piles one lie on top of another, into his now five… supposed executive orders, as to matters he has no real power… to implement. End, updated portion.

This is (again) back to our wheelhouse… and the “order” Trump signed overnight… is in fact, just a series of “demonstration projects” — or aspirational studies, if you will — to be experimented with… yup, after the election.

So — precisely as we earlier repeatedly said, most recently in July 2020… his order is a nullity. Yet another false promise, from a false despot.

Y A W N.

Here’s more from those capable, well-informed humans at STAT+, on it all:

…The executive orders direct the HHS secretary to test the ideas before making them permanent.

It’s still unclear when the Trump administration will formally implement the new executive order. Drug industry lobbyists expect Trump to try and skip over most of the formal regulatory steps by issuing a so-called interim final rule, a rare regulatory maneuver that lets presidents skip most of the formal regulatory steps in certain emergencies. However, the drug industry has hinted it will sue if Trump tries to use that maneuver….

Now you know (and we may yet add that, to the perhaps over 1,000 suits now pending against ultra vires Trump power grabs). Onward, grinning at Trump making up, out of whole cloth, an award he called the “Bay of Pigs” award, and then claiming Miami area Cuban-Americans gave it to him — as supposed proof of his chances of winning… in Florida. It would all be deliciously comedic, if not uttered by the sitting president, and thus not… so desperately… sad.

नमस्ते