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[Life-Sciences Tangent:] Emergency Use Authorization To Be Sought, For Ridgeback / Merck’s Molnupiravir (MK-4482) COVID-19 Pill…

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This is now two strong days in a row, of great news for Merck. And while the MK-4482 candidate pill has, when given early, reduced the rate of death by about 50 per cent in smallish early clinical trials, I’d expect that data here to hold up, more generally. So this really is a breakthrough — to have a proven highly effective, and oral, medication — for COVID-19 therapy.

I am not certain that it should increase Merck’s NYSE stock price by nearly 10 per cent (now, ~8.5% in late afternoon trading), in a single day, though. I suppose one might argue that Merck was undervalued, before today — and the dam has broken. . . but I don’t really think a stock as widely followed as Merck is ever really trading without all the information in the price.

And to make my point, more directly — the price pressure on this pill, as it comes out of the gate — assuming FDA clears it — and FDA will. . . will be extraordinary. In much of the still-developing world, it will need to be essentially given away (likely ultimately as A WHO “essential medicine“).

Bear in mind, that we have reached 700,000 deaths in the US, alone — and over five million, globally. This is a pandemic event, unlike any we’ve seen in over a century.

And so, a pill that cuts those grim tallies in half. . . well, it will be. . . in demand, everywhere — but not at hundreds of dollars, per dose. [Perhaps not even at tens, per dose.] We shall see. It is great news, for humanity, and Merck — but it is unlikely that Merck / Ridgeback will be able to command monoclonal antibody (i.e., Regeneron-level) pricing. Still — here is the good news:

. . .[Merck and Ridgeback Bio] announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. . . .

At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide. . . .

We shall, as ever, see. But Merck is no doubt (once again — post about 2012) a great company. Smart and increasingly agile, in its reactions to changing markets. And ethical, in saving lives. Smiling. . . ever. . . smiling.

नमस्ते

It Is Interesting… That Hinderaker Has Been Mum… About The Gov. — In The Dakotas….

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First, there’s the admitted fact that she fired a state level bureaucrat for not giving her daughter a license, for a business.

That’s entertaining, as she claims it is an attack on her children. Nope — it is a question of her own… corrupt motives.

But now, Trump’s early 2016 male (married; four children) campaign manager is (according to right wing news outlets) having an ongoing affair with that very same (female) governor. Who is also… married with kids.

“…Bueller…. Bueller…?

Bueller?…. Ferris Bueller?”

Grinning.

Tangerine Motion To Dismiss Denied: Eddy Grant May Get To A Jury, On Whether “Electric Avenue” Was Stolen By Baby-T’s Campaign In 2020…

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This is not unexpected, given the brazen nature of the theft of this artist’s work, by Baby-T and his people. But it is good news, to be certain.

It also makes out a nice case of classic “false light” publicity, having been viewed over thirteen million times (for which the artist’s consent was never even sought — let alone obtained, by the MAGA campaign people), since Tangerine well-knew that an aritst singing a song about British police brutality against people of color, in the 1980s, would not be any form of endorser of any of Baby-T’s lawless and still ongoing racist behaviors.

Here’s the latest update, on this fascinating case — a 21 page memorandum opinion entered tonight by the able USDC Judge Koeltl, in Manhattan:

. . .The video — in particular the contrast between the trains and the unflattering nature of the excerpted language from President Biden — appears intended to criticize President Biden and depict the strength of former President Trump’s campaign. Grant’s song can be heard beginning at around the fifteen-second mark of the video, and continues through the duration of the fifty-five second video. . . .

[T]he video had been viewed more than 13.7 million times; the Tweet containing the video had been “liked” more than 350,000 times, re-Tweeted more than 139,000 times, and had received nearly 50,000 comments. Compl. ii 43-44. The defendants did not receive a license or Grant’s permission to use the song in connection with the animated video. . . .

In this case, the video’s overarching political purpose does not automatically render its use of any non-political work transformative. See, e.g., Henley v. DeVore, 733 F. Supp. 2d 1144, 1164 (C.D. Cal. 2010) (rejecting fair use defense at the summary judgment stage where creators of political campaign ads rewrote some of the lyrics but appropriated the melody, rhyme scheme, and syntax of two Don Henley songs without permission); Browne v. McCain, 612 F. Supp. 2d 1125, 1129-31 (C.D. Cal. 2009) (rejecting fair use defense at the motion to dismiss stage where a political campaign ad featured a Jackson Browne song without permission, even though other audio was played on top of the song). As to the character of the video’s use of Electric Avenue, it is best described as a wholesale copying of music to accompany a political campaign ad. . . . In this case, the video’s creator did not edit the song’s lyrics, vocals, or instrumentals at all. . . .

It is plain that widespread, uncompensated use of Grant’s music in promotional videos — political or otherwise — would embolden would be infringers and undermine Grant’s ability to obtain compensation in exchange for licensing his music. The [Trump Team does] not seriously dispute this. . . .

Baby T’s remaining campaign funds, and the GOP’s, are going to have to foot a very big bill here — in about a year, when Mr. Grant wins on the merits. And that will be. . . rough justice. . . grin.

[As a footnote, we will also report that Tangerine’s preposterous NDA provisions were tossed by a New York arbitrator last Friday, freeing up Omarosa’s book sales, and appearances (and perhaps, eventually, even video tapes of Trump uttering racist swearwords) for publication and dissemination. The public has a right to know about views of the occupants of 1600 Penn — a right that exceeds the rights to privacy of ordinary people — those who do not seek higher office.]

नमस्ते

Now Over Forty Years On: He Was Living In My Town, In Early 1981… Thus My Interest.

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Quite unlike the Sirhan Sirhan opinions I offered last month, this attempt did fail — and in my opinion — the attempt had a negligible effect on the course of US history. That said, Sirhan has served far more years than John Hinckley, the would be Reagan assassin.

In any event, he is slated to by a fully-free 67 year old man, by summer of next year — per NPR’s reporting:

…Prosecutor Kacie Weston said the Justice Department agreed to a settlement but wanted to monitor Hinckley for the next nine months because of two big changes in his life: he’s living on his own for the first time in about 40 years, and because one of his primary doctors is preparing for retirement and disbanding Hinckley’s therapy group. DOJ said it would file a motion with the court before June of next year if it had fresh concerns about Hinckley….

Now you know — this is what our as revised laws require. And he has served his time, and his therapists say he’s at nearly zero risk of re-offending, as he’s been living in near freedom for three years, and has held a long term stable job.

I think that makes sense — and assassins are almost always very young white men. He has long past his expiration date on that. Onward.

[U] SB-8 Collateral Fallout: When The Quality Of The “Bounty Hunters” Is Of This Caliber, The So-Called “Pro-Lifers” Have Already Lost The War, In Texas…

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In the end, SB-8 will die. The Supremes simply cannot allow “vigilante justice” to be the rule here. There are manifold ways in which the bill, even as written, will be used to supress clearly enumerated Constitutional rights. But between now and when the Supremes get it, the anti-abortion forces will have a vast quagmire of miscreants to clean up. As will the Governor and the local judges, in the Longhorn State.

And by that, I mean the supposed “privately-injured parties“, who are now filing state and federal suits with the aim of recovering $10,000 per violation — in Texas, from alleged service providers. Take this first, most notable one. No. . . really. Please — take it.

It is brought by a convicted felon, serving home confinement for 15 years (now in his twelfth year!) in Arkansas (the bill imposes no geographical limits). Oh — and by his own admission, he’s a disgraced, and a disbarred former attorney, and a federal tax cheat. He is the face of this White-Knight / “justice effort” — in Texas. Charming.

I won’t quote any of his suit — as it is in the main, a rambling diatribe against the federal authorities who have properly convicted him of felonies (and taken his freedoms) — but along the way he demands up to $100,000 from these chuckleheaded Texas statutory schemes — as a supposed bounty hunter.

These are the kinds of “advocates” one draws, when one doesn’t have the brains to think things through — and then makes pacts with the worst of the MAGA elements.

These are the kinds of “advocates” one draws, when one doesn’t have the brains to think things through — and then makes pacts with the worst of the MAGA elements.
Updated, on Monday morning — consider this (as an observation in reply to a comment on the life-sciences blog property), from the latest filed emergency petition before the Supremes:

. . .It is a foundational principle of our federal constitutional system that “the federal judiciary is supreme in the exposition of the law of the Constitution,” and States may not nullify federal rights through “evasive schemes” designed to foreclose federal judicial review. Cooper v. Aaron, 358 U.S. 1, 17–18 (1958). Had a State after Brown v. Board of Education, 349 U.S. 294 (1955), enacted a similar law authorizing private citizens to sue anyone integrating a school, there can be little question that this Court would have immediately stopped that act of lawlessness. That S.B.-8 seeks to frustrate the right to abortion rather than the right to equal protection cannot justify different treatment. . . .

Welcome to the public relations nightmare, you Roman Catholics (among others), in Texas. You clearly bargained for it.

नमस्ते

This Should Spell The End Of That Judge Tipton-Led Bit Of Judicial Activism In Texas…

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The latest federal brief (as filed tonight, on USDC Judge Bruce Drew Tipton’s docket) makes a very-muscular argument that this case needs to die — by quoting the Fifth Circuit opinion we discussed last week, back to the trial court Judge — and suggesting the Biden Administration priorities now being set are not reviewable, until final. And they are not yet… final. There is no case or controversy in the language of Ex parte McCardle. Sweet:

…Regardless, discovery is particularly inappropriate in this case in light of the Fifth Circuit’s recent conclusion that the Department of Homeland Security’s (“DHS’s”) immigration enforcement determinations are committed to DHS’s discretion and are not subject to judicial review. See Texas v. United States, — F.4th —, 2021 WL 4188102 (5th Cir. Sept. 15, 2021) (“CA5 Stay Op.”). In fact, the Fifth Circuit Court found “it is instructive that the Supreme Court has never allowed judicial oversight of such decisions” because decisions about “who to arrest and charge,” are matters “committed to law enforcement discretion.” Id. at *4 n. 4 (5th Cir. Sept. 15, 2021); see also id. at *5 (noting that it did “not see a strong justification for concluding that the [Illegal Immigration Reform and Immigration Responsibility Act] detention statutes override the deep rooted tradition of enforcement discretion when it comes to decisions that occur before detention, such as who should be subject to arrest, detainers, and removal proceedings”)….

“‘Without jurisdiction the court cannot proceed at all in any cause.’” Steel Co. v. Citizens for Better Envt., 523 U.S. 83, 94 (1998) (quoting Ex parte McCardle, 7 Wall. 506, 514 (1869)). The same principle applies when claims are barred by threshold questions, such as when the challenged agency action is committed to agency discretion and therefore not subject to judicial review. See 5 U.S.C. § 701(a)(2); cf. In re United States, 138 S. Ct. 443 (2017) (per curiam) (instructing district court to resolve threshold questions before requiring government to compile administrative record). A court must therefore consider the threshold questions before addressing the merits of a claim, including discovery. Here, because Plaintiffs cannot overcome numerous threshold limitations, discovery is improper….

Now you know. This one is dying on the vine… and I for one am grinning.

At $2,100 A Dose, 70% Of All Recent COVID Monoclonal Antibody Shipments Have Gone To Seven Southern States (Six Led By GOP Governors)

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And, stultifyingly — in at least one state — Tennessee, this very expensive, cutting edge treatment is being prioritized for people who did NOT get a pair of $10 per jab vaccines. What?!

Yes — all newer meds must be rationed, along some lines — in any event — but that sure seems to “reward” poorer health choices (at least as compared to older Tennesseans, who immediately went out and got the vaccine, but now have a Delta-driven breakthrough variant to contend with). Why would they be sent to the back of the line? Bizarre.

. . .“If we had enough to give this to every single person at risk of hospitalization, that would be ideal,” Dr. Karen Bloch of Vanderbilt University Medical Center told The Tennessean. “But with this limited resource, identifying those most at risk makes sense. Taking out the politics, the unvaccinated fit into that category.”

Monoclonal antibody treatment lessens the severity of Covid-19 symptoms, and with more cases of the highly infectious delta variant, the demand for it has soared.

But in recent months, 70 percent of the country’s supply has gone to seven Southern states: Alabama, Florida, Texas, Mississippi, Tennessee, Georgia and Louisiana. . . .

Of course, these states are those with most heavily burdened case loads, per capita — but a powerful argument exists, on the data, that the heavy case loads. . . are a result of the states’ own very poor pandemic management / policy approaches.

I truly do want the best outcomes for everyone, nationwide — and it should not be a death sentence to be a Democrat living in Florida for example. . . but the idea that these GOP governors are now saying the allocation is in some manner. . . unfair, to them. . . is preposterous. [Tennessee in particular sports the lowest percentage vaccinated — just over 44 per cent, according to most recent data.]

As a nation of limited health care resources (due to purely fiscal restraints), I am troubled that these states taking the least responsible, least proactive approaches to managing the pandemic. . . are consuming the most — of the higher end treatments, once a crisis in their geography (almost inexorably) arises.

नमस्ते

It Must Be Said: This Is Wrong. It Violates All Our Treaty Obligations. Period.

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Border Patrol agents using whips, on horseback, trying to drive Haitian asylum seekers back into the river, and to the Mexican side of the border… is dead wrong. It is unlawful. It is… cruel. Any sentient human knows this.

Whether Mr. Biden or someone else might be, or is in charge — it needs to end. Right now.

Either we are a nation that honors her treaties — or we are not. There is no middle way, tonight.

Updated: For its part, the White House is gathering video evidence. If it depicts what the reporters say, these agents should be immediately cashiered (and face criminal charges, if the video supports the same).

More directly… we must offer each migrant a credible fear interview, if they request the same, on aprehension.

That is black letter law.

Onward.

नमस्ते

When Nearly Seven Decades Worth Of SCOTUS Perspective, Speaks: Do Listen To Lyle Denniston…

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Lyle Denniston is… a national treasure, and a living legend. He has ably covered the US Supreme Court for now well-over six decades.

Mr. Denniston, as to matters of politics at the Court, has generally been… fastidiously taciturn — for fifty years. A half-century, minimum — so, when he offers an opinion, we should listen. Go read it all, but here is a bit:

…It is true that the Court did refuse to go along with former President Trump’s boldest attempt to undo the 2020 election victory of President Biden, but the reality is that some of the Justices had shown sympathy along the way for the basic – and highly questionable — notion that the ultimate constitutional control over presidential election machinery lies with the state legislatures.

Moreover, the venues where the Justices sometimes choose for public appearances do contribute to the public perception that they play favorites among political activists. Justice Barrett’s speech lamenting the Court’s reputation as political was delivered at a Kentucky center established by longtime Senate Republican leader Mitch McConnell, and with him sitting on stage.

And, of course, it was McConnell who blocked President Obama from making a Supreme Court appointment to save the seat for Donald Trump in case he won in 2016. And it was McConnell who rushed to put Barrett on the Court on the eve of the 2020 election to deprive Joe Biden of the opportunity if he were to win the presidency.

In short, some more rigorous self-examination may be in order among the Justices of their own role in adding to the reputation of a Court that may have grown too political for its own good….

Wise words, indeed. Onward, smiling….

नमस्ते

Dewormer… Did NOT “Cure” India — And Other Lunacies…

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I’ll likely regret mentioning it, but the people deplatformed from Twitter now often appear on a service called Gab.com.

The moron at right was full of polling and pandemic lies from 2017 to 2020 on Twitter.

Now he is full of them at much smaller — and failing — gab.

Good riddance. But the idea that humans are injecting themselves with a bovine dewormer… and former river-blindness drug (from use in sub-Saharan Africa). . . is simply. . . beyond the pale.

Onward, to baking — with baby-girl!

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