Category: Uncategorized

Emergent Gets Accelerated FDA Green Light For Its Mpox Vaccine Candidate…

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Emergent joins Bavarian Nordic now, with the ability to contract deliver vast doses of its vaccine to any country that accepts FDA clearance rules.

Here’s the latest on all that, from the able reporting of FiercePharma:

…The FDA signed off on the vaccine’s use as an mpox disease preventive in those deemed to be at a high risk for infection.

“This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases,” Emergent CEO Joe Papa said in a company press release. “We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply.”

Until now [Bavarian Nordic’s] Jynneos was the only FDA-approved mpox vaccine, leaving Bavarian Nordic racing to fulfill several supply contracts from various governments and public health agencies. That vaccine helped to curb previous mpox outbreaks in 2022 and 2023. The company looks to supply 2 million doses this year and 8 million in 2025 to help to further contain the virus….

Now you know, on a lazy and quiet long weekend here. Grinning, as Tangerine flip-flops, and back again, on women’s rights to control their own bodies. It is finally dawning on him that he cannot crack 40% of American women voters unless he flip-flops — and he loses 95% of the X-ian votes, if he does flip-flop. Private health-care choices — and bodily autonomy — are fundamental rights, as Kamala well knows — and has lived, her whole life. Onward.

नमस्ते

Too Much Ketamine, Tonight, John? Seems So…

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Late night tonight, Hinderaker points to a dumb crypto bro betting website called Polymarket, to (preposterously) infer that Tangerine is either in a dead heat, or holds a slight lead — over Kamala Harris. Hilarious.

Of course, the crypto bros (and 27 year old Wall Street morons) are leaning Tangerine.

Out in the real world, though — where regular (voting) people work regular if thankless jobs, pay taxes, and look out for their neighbors (and not just their Bugattis!)… Harris is plainly 7 to ten points ahead — and maybe more, in several swing states (save only Nevada).

That’s what actual non-partisan polling shows.

And, moreover, John’s fairy tale of an even race utterly ignores that Trump is now between 10 and 15 percent NET unfavorable. [Prior to the GOP convention it had narrowed to between 8 and 10 points.] And to be sure, he has been 10 per cent or more underwater on favorables, for months and months, now.

Critically, now over 54 percent of US voters think of him UN-favorably — while under 42 percent think favorably of him. No one with over 51% unfavorables, or a more than ten point “net deficit” has ever won a national election. Ever.

By contrast, Kamala’s favorables have bloomed over 50%, post the Democratic convention — to 53% as I write this.

Her unfavorables are now below 45%… and declining daily. [Sure, a black swan event could still happen, but at 66 days out, it’s becoming less and less likely.]

She’s in nearly ten point net favorable territory (not yet quite Obama 2008 numbers, but trending in the right direction). John derides this as “vibes”. I call it… a result. A result — of running a felon.

Yep… Hinderaker’s again… delusional, and increasingly demented “hopes” — are for an imaginary lost world, and running face first into an electorate that is now sick to death of his idiotic and hateful lies.

MAGA lies. Tangerine… lies.

It is still a reasonably close race — but she clearly leads now. And Trump has hit his inexorable vote ceiling. Nothing left in “his tank”.

So turnout is the Democrats’ big gun, now (especially in WI, MI, AZ and PA). And, yep…

She will… win! ¡Si Pueda!

An Empty Boeing Starliner Will Come Home Around Midnight Sept. 6-7…

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This is a smart, conservative move. Never take an avoidable risk, with live crew.

[And if it doesn’t go well, most of America will be sound asleep.] But to be clear, I do expect it will bounce safely onto the ground in the western United States, at White Sands, New Mexico. Here’s the latest, from NASA — coverage details, too:

. . .NASA will provide live coverage of the upcoming activities for Boeing’s Starliner spacecraft departure from the International Space Station and return to Earth. The uncrewed spacecraft will depart from the orbiting laboratory for a landing at White Sands Space Harbor in New Mexico.

Starliner is scheduled to autonomously undock from the space station at approximately 6:04 p.m. EDT Friday, Sept. 6, to begin the journey home, weather conditions permitting. NASA and Boeing are targeting approximately 12:03 a.m., Saturday, Sept. 7, for the landing and conclusion of the flight test…

NASA astronaut Nick Hague and Roscosmos cosmonaut Aleksandr Gorbunov will launch no earlier than Tuesday, Sept. 24, on the agency’s SpaceX Crew-9 mission to the International Space Station. NASA astronauts Zena Cardman and Stephanie Wilson, previously announced as crewmates, are eligible for reassignment on a future mission…

The updated crew complement follows NASA’s decision to return the agency’s Boeing Crew Flight Test uncrewed and launch Crew-9 with two unoccupied seats. NASA astronauts Butch Wilmore and Suni Williams, who launched aboard the Starliner spacecraft in June, will fly home with Hague and Gorbunov in February 2025….

Now you know. Onward.

नमस्ते

Billingsley — On Steve Kerr’s Father — Ought To Be Horse-Whipped.

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And… Exhibit 402(b) — of more desperate lying, and mis-characterizing of US heroes’ life stories, because the boys know Tangerine is both going to jail — and going to lose, in Nov. 2024.

As more evidence of this desperation in the MAGA deep core — this morning, Billingspuss attacked Steve Kerr — and his father’s service to this nation.

Damn.

Reached for comment, about Billings-pussy, Coach Kerr told reporters it was “pretty disgusting” and wondered “how the minds of fools work….”

F L A W L E S S.

Oh — and LeBron James was watching my Buffs last night, and when two way phenom Travis Hunter (with 4.05 speed!), caught an impossible ball on the edge of the end-zone to “HBO” (“help a brutha’ out”) from Shadeur Sanders (both very likely top five Heisman candidates if they stay healthy)… King James called him “Ridiculous!” — [“One of one” — whoever has No. 1 NFL draft pick next spring, no matter what position you need — pick Travis. He can play anywhere, and every other team will offer anything you want — to get him.] Watch this:

Out.

नमस्ते

[U: Hinderaker Joins The Lies!] Scott Johnson — For The Loco/Lunacy Contest Winners (En MAGA)!

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Updated — 08.31.2024 @ Noon: Now Hinderaker feels that the absence of a fry cook job, forty some years ago… on a resume, some 20 years ago… is disqualifying. [As the new graphic indicates… he thinks it “stolen valor” — insulting both Marines, and fry cooks (like me!) from a half-century ago… everywhere. Damn, son.]

This is… too precious for words! These malign, bitter lil’ trolls have nominated (checks notes) a 34 time felon; a guy indicted in 60-some more felonies; a serial sexual predator; a guy who owes JUDGMENTS of over $400 million for bank- and tax- frauds in NY state; a guy who (despite swearing he would!) has never shown his 1040s, even a decade later… and a guy… who invited a mob to kill his own VP, when he wouldn’t join his insurrection against the United States of America’s laws on peaceful transfer of power.

Holy shit, boys — it’s a fry cook job — McDs doesn’t keep complete backup record copies of 45 year old summer jobs, by millions of then-teenagers. You two are idiots. And this kerfuffle shows just how desperate you morons are. End updated portion.

It cannot be swept under the rug any longer.

All of the hard right GOP, and the MAGAts, are now so desperate (seeing the election slip away from them day, by fateful day) — because they alone chose to re-nominate a fraud and felon and sociopath — that they are complaining about what my Madame President and Tim might have eaten for breakfast in fourth grade (and what each recalls of it!).

This is a sure sign of a failure: these morons, Scott especially, are repeating lies… or at best, misleading characterizations of others’ long faded recollections… to demonize Kamala. The latest? Scott claims she never worked at McD’s as a kid(?!). She wasn’t a fry cook. Y A W N.

Let us pretend for a moment that every bit of this lunacy checks out. [It doesn’t, BTW.] The idea that McDs must verify — 45 years later — every person who ever worked at any non- corporate franchise (any non-owned and operated “mom & pop” one) by digging up paper copies… is frankly insane.

The idiots make much (they think!) of McDs not appearing on her application to be a prosecutor. Idiotic. By the time I was 21, I had worked 23 different W-2 generating (wage) jobs — to pay for undergrad. When I got my first Summer Associate job at a large Chicago law firm, I did not list my time as a taffy puller, or a dishwasher. Why? Because… making candy from scratch (or cooking fries) might not be relevant experience, for writing M&A agreements (or prosecuting predators).

So… even if she didn’t cook fries at McD’s (but she likely did — it’s a terrible job — and one I too did, for a few weeks at a competing burger franchise, as a 16 year old!) — and even if she only directly first chaired 50 felony trials as a California prosecutor, as opposed to the 100 she worked on, over all… [that’s fifty more than Scott or John or Stevie! And 100 more than Trump — though Trump has been indicted in at least 93 felonies so far, AS A DEFENDANT!]… Scott Johnson’s implication would be that she is less Presidential than…

The “just grab her by the p#ssy” guy?! Than a convicted felon? Than a guy who owes the best part of $500 million in bank and tax fraud judgments?! A guy who despite endless promises, has never released his full 1040s? Who is very likely being investigated, again for federal tax fraud?! A guy who had his people assault and batter an Arlington federal employee, in order shoot a campaign video (itself a separate violation of federal law!) — and post a “thumbs up, sh!t-eating grin” photo — while standing on the graves of several Marines whose families oppose their fallen heroes being used in a felon’s campaign ads?! See, 32 CFR Part § 553.32(c): “…Memorial services and ceremonies at Army National Military Cemeteries will not include partisan political activities….” [In Section 60, only official stock Arlington footage is allowed. No private filming. At all.]

A guy who called all the WW II dead “losers and suckers”?! A guy who said he prefers Vietnam-era Air Force pilots / POWs / heroes who “don’t get captured“?!

All while he took six deferrals for “bone spurs”?!

Please, Scott — just STFU. You are an embittered, incontinent, lying and yes whiny lil’ b!tch ass.

Take a seat.

I’m A Couple Days Behind, In Reporting This — But A WHO-Sponsored Scientific Conference Is Underway, Through Tomorrow Night — On Mpox Strategies…

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The time to move… is well past due, here.

So as we speak, bulk vaccine stock is being ginned up, in large pharma facilities dotting the globe. But it will be weeks yet before the nearly one million immediately needed vials are shipped toward sub-Saharan Africa.

So in the mean time, as with Ebola, a ring vaccination strategy is underway: contacts — and contacts of contacts will see the first jabs. But the teams on the ground will be stretching with the first ~130,000 doses… until the next ~200,000 courses arrive in about ten days. Here’s the detail, about the conference — I’ve been listening in, in the background, via an audio only link:

…Strategic vaccination efforts will focus on individuals at the highest risk, including close contacts of recent cases and healthcare workers, to interrupt transmission chains.

At the global-level, the emphasis is on strategic leadership, timely evidence-based guidance, and access to medical countermeasures for the most at-risk groups in affected countries.

WHO is working with a broad range of international, regional, national and local partners and networks to enhance coordination across key areas of preparedness, readiness and response. This includes engagement with the ACT-Accelerator Principals group; the Standing Committee on Health Emergency Prevention, Preparedness and Response; the R&D Blueprint for Epidemics; and the interim Medical Counter Measures Network (i-MCM Net).

The WHO R&D Blueprint, along with Africa CDC, Coalition for Epidemic Preparedness Innovations (CEPI) and National Institute of Allergy and Infectious Diseases, will host a virtual scientific conference on 29-30 August 2024 to align mpox research with outbreak control goals.

“The mpox outbreaks in the Democratic Republic of the Congo and neighbouring countries can be controlled, and can be stopped,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Doing so requires a comprehensive and coordinated plan of action between international agencies and national and local partners, civil society, researchers and manufacturers, and our Member States. This SPRP provides that plan, based on the principles of equity, global solidarity, community empowerment, human rights, and coordination across sectors.”

WHO headquarters and regional offices have established incident management support teams to lead preparedness, readiness and response activities, and are significantly scaling up staff in affected countries….

Updated — 08.30.2024 AM: Oh — and LeBron James was watching my Buffs last night, and when two way phenom Travis Hunter (with 4.05 speed!), caught an impossible ball on the edge of the end-zone to “HBO” (“help a brutha’ out”) from Shadeur Sanders (both very likely top five Heisman candidates if they stay healthy)… King James called him “Ridiculous!” — [“One of one” — whoever has No. 1 NFL draft pick next spring, no matter what position you need — pick Travis. He can play anywhere, and every other team will offer anything you want — to get him.]

Now you know. Onward, resolutely. Onward [Go Buffs!].

नमस्ते

Two Immaterial Discontinuations Of Clinical Trials — For Combos, With Merck’s Keytruda, In Hard To Treat Cancers…

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Of course, Rahway would rather report robust efficacy in these daunting cancers. But stopping combo studies when there is no clinical benefit being seen… is responsible medical science. That way, patients may promptly seek other experimental options.

So it is that two more such stoppages were announced by Merck this morning. Here is FiercePharma on it all — in a longish and well-sourced rundown:

…[A] combination of Keytruda and Merck’s investigational anti-TIGIT antibody vibostolimab was found to be less effective than the chemotherapy docetaxel in a phase 2 trial in previously treated metastatic NSCLC. Merck still has three ongoing phase 3 trials for MK-7684A, a fixed-dose combo of Keytruda and vibostolimab, in different NSCLC settings.

In the wake of Merck’s latest setback, the search for a viable PD-1/L1 inhibitor in stage 1 or 2 unresected NSCLC is still ongoing for at least one other company. AstraZeneca is conducting the phase 3 PACIFIC-4 trial, testing the addition of its PD-L1 inhibitor Imfinzi to radiotherapy in a similar design to Merck’s KEYNOTE-867 trial. The AZ study started about three months earlier than its Merck counterpart, and it has a separate cohort examining the British pharma’s Tagrisso following radiotherapy in EGFR-mutant tumors….

Now you know… this will be a very high revenue world-beating franchise into the early 2030s, minimum. Onward, into a relaxed barbeque filled long weekend with extended family — and the “Coach Prime” CU Buffs back in action, from Boulder on Tee-Vee (nationwide) tonight! Woot!

नमस्ते

[U] In Which Hinderaker Forgets… What An “Editorial” Is: An Opinion Page. Opinion.

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Silly update: Hinderaker has removed the front page treatment for his item below.

I think he realized… his is an idiotic take on the law. You can still see it at the link, but if you don’t know its specific URL you can’t find it. Charming. End update.

John is even dumber than he looks.

Sure, the Second Circuit gave the odious Sarah Palin the green light to obtain a new trial this afternoon. But when she loses again, and she will lose again, she will owe additional legal defense fees to the New York Times. [The Times corrected the errors promptly and apologized.]

She already owes well over $40,000 in those fees (and will have to pay her own lawyers to retry the case), and may end up with well over $150,000 needing to be paid for the defense lawyers of the New York Times.

Let us also stipulate that she is without a doubt, a public figure in this trial.

Finally, the district court judge will be allowed to take judicial notice of the fact that all of the complained of statements appeared on the editorial page. They were couched as opinions — exclusively. She may feel the opinions were unfair, but they were the opinions of the editor. The matters address responsibility for shootings, and her hateful graphics that may have led to a sense of “permission”. Here’s the bit, about the mass shooting of Rep. Gabby Giffords:

“I think this [was] an example of very unfortunate editorializing on the part of the Times,” Rakoff said in court. “The law here sets a very high standard [for actual malice]. The court finds that that standard has not been met…”

A claim of a link — or permission — is a matter of opinion. That opinion is protected under the First Amendment, as a matter of political import — and public concern — under an uninterrupted line of cases stretching back 150 years — at the United States Supreme Court.

So in sum, despite what Hinderaker says, I highly doubt she will retry the case. She will simply owe double what she owes now if she does so.

But no one ever accused her of being the sharpest tool in the shed. So we shall see.

[John wants to conflate Palin’s — with his pet case, where a climate change denialist accused a climate scientist of being a pedophile.

That was a purportedly factual statement, — though it was utterly false, and was uttered about someone, in their private life. And so the climate change denialist lost, in DC. He committed libel.]

Charming.

There’s Been Some Inaccurate MSM Reporting, On The Biden Student Loan Measures — At The Supremes…

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The non-reasoned, one sentence order of this morning does only one thing.

It encourages the Eighth Circuit to make a quick decision, so that the whole dispute may be returned to the Supremes on the merits.

That’s all. [As to politics, though today’s tiny order is in some measure — a cowardly punt by the far right justices, knowing that if as it seems increasingly likely, Tangerine loses in the November elections, there will be zero downside to agreeing that Mr. Biden does have the 1960s Education Act authority to do this.

Nothing else. Sure it COULD have lifted the temporary injunction, but it did not — because it expects a speedy answer, here — and a return to the high court, if Mr. Biden comes up short on his appeal. So this means… almost nothing.

And in any event, Madame President Harris, come January 2025, is very likely to reinstate it, with a few tweaks — or even have the Democratic majorities in both chambers (by then) enact a legislative work-around. One that takes it out of the Supremes’ ambit, altogether.

Alternatively, as we’ve said before — the Supremes will ultimately rule (in about the seventh month of the 47th — Harris — Presidency!) that the program was a lawful exercise of Executive Power, under long-standing Congressional Acts.

Finally, I predict Tangerine (now behind in all reputable polls) will suffer a sudden, debilitating flare up of bone spurs — and bow out of all debates with Kamala Harris. She will mop the floor with his toupée, if he is dumb enough to keep the debate date.

Go — and be excellent to one another. Fight for the future of our relatively fragile but pluralistic dream. Out.

नमस्ते