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Courtesy CIDRAP, We Learn That Soligenix (NJ) Won FDA “Orphan Drug” Designation, For Its Novel Ebola Vaccine Candidate, Active Against Sudan Variant…

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To be certain, the war is being won, month by month, in terms of efforts to mitigate additional Ebola virus outbreaks in Sub-Saharan Africa. The education of the public, coupled to rigorous safe burial practices, when a case is suspected, have done wonders. That, and using ring vaccine strategies — as to all contacts of contacts, in an affected community. The outbreaks now rarely exceed 20 cases, and often with fewer than five fatalities. [Today’s good news comes courtesy of the arm of the University of Minnesota’s Med School’s CIDRAP website.]

But all of that vaccine strategy only works for outbreaks of the older, Zaire variant. One of the most recent outbreaks (in September of 2022) was of the Sudan variant, and was thus cause for grave concern — even when the careful public health efforts are able to arrest the spread. [In fact, the Sudan variant vaccine candidate has not been widely tested in the field yet, due to the rapid shutdown of transmission through public health outreach efforts.]

Here is just one of our prior backgrounders, on the Sudan variant — but it remains an open and gaping hole, in the defense net, for ring vaccinations, should another outbreak occur (and it is a near biological certainty there will be another).

So, it is wise that FDA will provide the New Jersey pharmaco with the streamlining review of an orphan drug designation. Orphan drug status also allows for greater overhead absorbing pricing, but is not designed for sponsors to recuperate all the costs of drug development. Rather, it confers a seven year exclusivity period (regardless of patent status), as a cost reduction and regulatory streamlining mechanism.

The FDA can, and occasionally does revoke orphan drug designation, if the side effect profile becomes too daunting, in aftermarket monitoring, or if initial estimates for efficacy turn out to be materially incorrect. But in this case, that would seem unlikely. So here’s the latest:

…Soligenix, a biopharmaceutical company based in New Jersey, recently announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax, its subunit protein recombinant vaccine as prevention and postexposure prophylaxis against Ebola Sudan, for which no vaccines or treatments currently exist.

Ebola Sudan is the second most common cause of human Ebola infections. In 2022, Uganda experienced an Ebola Sudan outbreak that resulted in 164 cases, 55 of them fatal. Earlier this year, the company reported that a bivalent (two-strain) version of the vaccine in a nonhuman primate trial provided complete protection against Ebola Sudan and Marburg viruses….

Now you know — and this development caused Soligenix’s stock to pop (more than double) on the NASDAQ, from $0.38 a share on Friday, to $0.83 per share by 10:00 am Eastern this morning — though it has since retrenched a bit, this afternoon.

Onward, to a sunny Tuesday — with Tangerine falling asleep at his own felony hush money trial in Manhattan. Charming. But grinning — just the same.

नमस्ते

The Bigger News Here Is Clarence Thomas Was Not Present Today — For Arguments…

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It is likely he is… ill. Justices almost never miss argument days.

How ill? Ill enough that the court’s information office had no prepared remarks, on it.

We will wait and see — but in each prior absence, the Chief explained briefly the nature of the medical issue — for Bader-Ginsburg, and later, Gorsuch. He also explained when Thomas last missed a session.

But not today. Karmic revenge a-comin’, for the Merrick Garland nonsense, as “The Notorious” passed?

Maybe.

The other real news out of Manhattan is that Tangerine is going to have to attend a hearing that might include jail time, for weekend violations of the gag order imposed by Judge Merchan.

The live bloggers have it thus: “…Prosecutors said they want Merchan to punish Trump for violating the judge’s gag order by sharing certain social media posts over the weekend.

They said they want the judge to sanction Trump for each of three posts, to tell Trump to take down the posts, and to warn him that another post could result in jail time….”

That hearing may come on April 23 or 24, 2024, now — as potential jury members’ questioning continues.

And… I hesitate to even mention it, but…

I also write (sort of trivially) to point out that (contrary to what Hinderaker supposes) saying — in an on air interview — that “I moved on her like a bitch” and “grabbed her by the pussy” — and did not even ask permission… IS prima facie evidence of… sexual assault.

It seems Hinderaker needs to see bite marks, or similar evidence of a violent struggle, in order to accept that it was an… assault.

This comes up, of course, because Tangerine’s prior (recorded and authenticated) admissions of sexual crimes are fair game in the current hush money trial.

And that hurts lil’ Johnnie’s precious fee-fees… or something.

And to think that Hinderaker has college age, and post college aged daughters.

Astonishingly, he this afternoon claims that Trump’s statements — about the women — are actually evidence that the women consented to being groped, or worse.

I wonder what his daughters think of that view.

Damn.

BREAKING — NASA Administrator Says “$11 Billion To Retrieve Samples From Mars Is… Just Too Much”: Live, Now

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The teleconference is live now.

NASA Administrator Bill Nelson is saying that we won’t cannibalize other missions, for the return of samples. But the mission cost has doubled in the decade since launch of the rovers. And waiting for humans on Mars (circa 2040) is entirely too long to wait.

So, a request for proposals from private industry partners (cough! Musk / Space X) will be concluded by this Fall — and the guideline will be “at or under” $5 billion, to return at least some of the samples (but perhaps not all 36 of them), by mid 2030. Now you know.

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So… Hinderaker Thinks It A Defense To Say… Bribery… Is LAWFUL?!

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Not that I really care that Hinderaker doesn’t read very well, but in New York, theft of honest services is a crime.

And the “catch and kill” routine (through fixer Cohen), in addition to being a federal campaign law violation, is thus a “corruption” felony under NY state law — compounded by Trump’s intentional lies about the nature of the payments made.

So Hinderaker’s framing of the charges… is misleading to the point of falsity.

And yet, as John acknowledges, Alvin Bragg will get a conviction — that much is certain.

So — Hinderaker’s GOP candidate will be a convicted felon as he heads out of the Milwaukee convention, as the candidate for 2024.

Charming John. There was a time when… well… never mind.

You’ve become all the things you’d long said you’d despised about your pop’s generation.

Hilarious.

In An ACTUAL Case Of Chilling Free Speech, At The Supremes…

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The Supremes do occasionally issue rulings about the actual contours of what is allowed protest speech, as contrasted from prohibited lawless conduct.

In a case out of Louisiana — during George Floyd protests, a BLM member was held liable for what Louisiana called the “negligence standard” of injuries to a police officer working the protest. The trial court tried to hold an individual, who signed the protest permit liable, when an officer was injured at the protest — on a negligence theory (that it was “reasonably foreseeable” that an officer might be hurt, if the crowd grew too agitated).

What in fact transpired was that the Fifth Circuit then held that petitioner DeRay Mckesson, the leader of a Black Lives Matter protest in Baton Rouge, Louisiana, could be liable, under a negligence standard, for serious injuries sustained by a police officer when an unidentified individual attending that protest threw a hard object that hit the officer in the face. But speech cannot be punished on a mere negligence standard, as the courts have long held. Doubly so, where the person being sued (without dispute) was in no manner involved in the random throwing of the object. He was well-away from where that occured.

That “negligence standard” had never been the law, for a pure speech protest permit.

And since then, the Supremes decided Counterman, in any event. That case held that law enforcement must prove — in true-threats cases — that the defendant had some subjective understanding of his statements’ threatening nature, as the First Amendment requires a more demanding showing than just “recklessness“. In this case, there were no threats made by Mr. McKesson, in the record — of any sort (and nothing “reckless”, in any event), against law enforcement in Baton Rogue. So the court held him liable on “negligence alone”.

And so, the able Justice Sotomayor writes this morning, to explain to the Fifth Circuit what the law — as developed — since Counterman v. Colorado requires of the State, in McKesson (in now its second time at the highest court).

Mr. McKesson (after Counterman), cannot be liable unless the State can show that he was “more than reckless” — in his encouragement of the crowds toward lawless conduct — and in any event, mere negligent speech won’t support his liability for the officer’s injury.

True enough, being a cop is a dangerous job. Guarding protests — and protestors — is part of the job.

He easily could have donned riot gear, but he chose not to. It was a hot day, and it would seem he expected the crowd would be largely peaceful. And it was.

Accidents do happen — and if one cannot find and arrest the bottle thrower — one cannot hold the organizer responsible under our First Amendment protections jurisprudence — certainly not on a mere negligence theory.

Yep, this McKesson case is plainly about state actions to restrict protected expression — unlike the ones that the Powerline boys yammer on about, week after week, occuring in private social media living rooms. [No state actions there.]

Now you know.

Bill Otis: “Not Much of Anything Really.” True.

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Not that I care (much), but Bill Otis says this tonight (and he’s more right than he knows):

…I guess nominally I’m Episcopalian, although not much of anything, really…

Yep — and he proves his lack of gravitas/seriousness… with claims like this: that liberals want to “get those Jews and Asians out of here and give the spots to underperforming blacks…”

Who on Earth is this… malign moron?

Out.

Some Apparent Humana Wrangling — On Whether It Will Fully Pay Plaintiffs’ Class Counsel, For The Settled Zetia® Antitrust Class Action In Virginia…

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An earlier order in the Norfolk, Virginia USDC had set five per cent of all settled amounts aside, for the benefit of the lawyers who’ve been working for nearly a decade now, on this massive multi-district federal class action litigation.

But at the end of last week, apparently Humana, Kaiser and Centene — through their local counsels — made some noises that their respective received settlement payments might not include a specific amount set aside for the class plaintiffs’ steering counsels. And so those lawyers have asked the able USDC Judge to appoint a bank as escrow agent, and have Merck and Glenmark pay the five percent — as the checks are cut, or wires transferred. . . directly into the bank escrow account for these long-laboring lawyers.

This is all so that the big insurers won’t be able to short them on the decade’s worth of fees and expenses — that got us to this multi-billion dollar settlement. [Here is just one of our earlier backgrounders, on the class action — more generally.] And from the memo requesting the appointment of a protective escrow agent, of April 11, 2024 — we read this:

…Specifically, CBF plaintiff Humana, whose counsel also represent CBF plaintiffs Kaiser and Centene, filed in its home court a “background and current posture” letter in which it claimed that the “continuing applicability of [this Court’s Common Benefit Order] is uncertain”, while ignoring that the Common Benefit Order expressly retained this Court’s jurisdiction, for enforcement purposes, “over each CBF Case regardless of whether the case is subsequently transferred or remanded to a different court for later proceedings or trial….”

Given the risks posed by this CBF plaintiff’s claim, the Court should immediately enter the proposed Escrow Agent Order to clearly establish Defendants’ reporting, holdback, and deposit duties and thereby immediately minimize the risk of loss and possible defiance of the Court’s Common Benefit Order….

I think the lawyers’ five percent totals nearly $90 million, as the various buckets of claims look to have settled for an aggregate of over $2 billion — running from about 2008 to 2023. And so, I would expect that the escrow order will be entered, and the insurers will not be able to pull an “end run” around class counsel — if that was even ever their intention.

If it is not their intent, then they should not complain about the escrow — and if it is, then the escrow is likely needed. Onward, smiling — with a busy, warm, museums-infused Spring week ahead.

नमस्ते

Paul Mirengoff Yet Again Offers Some “Damnable Lies” — About The 1960s… And Today’s Protests..

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I don’t give a crap about the banal hypocrisy Mirengoff displays about today’s college campus occupations / protests.

But the fact is he… and John and Scott did the exact same, about a cause they believed in, at Dartmouth as undergrads, in the ’60s. That they now claim to no longer believe in the things that animated their multi-day “takeover” of that campus administration building… is of zero relevance. They did it.

And… I. Don’t. Care. About. Their. Decades. Later. Disillusionment. Either. [They did it — so what’s up with the nonsense, son?!]

No, I write this Sunday morning to excoriate Paul Mirengoff, over his damnably entitled lie, below — in describing his time at Dartmouth:

“…But when students began taking over college administration buildings and manhandling deans as they escorted them out the door, the coddling finally came to an end (at least for protests led by white students). Eventually, colleges started calling in the police. At Dartmouth, our occupation of Parkhurst Hall resulted in 30-day jail sentences….”

[The bolded part by Paul… is uniquely malevolent.] Hey Paul… I would like to introduce you to… one Bull Conner. Or any number of Alabama police officers on the Edmund Pettis Bridge.

Please say hello, by the way, to the late great Rep. John Louis, or Martin Luther King, Jr…. or Andrew Young, or Ralph Abernathy or A. Philip Randolph. Or any of the migrant farm workers’ advocates in Southern and Central California, of the day — or the hundreds of young Black (and some white) students who died in the South just a few years earlier than your silly campus “jail sentences“. Jeez.

The notion that Black and Latin kids were treated with kid gloves, in ANY 1960s protest aftermath… is the product of an ensuing six decades of utterly unearned Whyte privilege, Paul.

Your privileges have caused a malign, selective amnesia — about what actually happened.

YOU were the ones handled with kid gloves, seeing your undergrad records cleared, and being graduated on time with honors, all. [John’s dad having secured the best of criminal defenses, in the Northeast — through his legal fraternities of Ivy educated Whyte Guys.]

Then each of you paddled off to the best US law schools (avoiding Vietnam altogether, by skipping the draft as “exempt” grad students) — the law schools being Harvard and Stanford, respectively. [And just on the notion of Vietnam, consider that Cassius Clay was stripped of his titles, jailed for over a year, and prohibited from fighting, in the prime of his career — solely because no lawyer told him to enroll in a graduate school to avoid the draft. No, he stood like a man, and said he would NOT go to kill his brothers in southeast Asia. He was treated better than you?! REALLY?!?]

Meanwhile, most of the civil rights protestors in the South endured fire-hoses, dog attacks, beatings and in many cases… far worse. Lynchings. Billy-clubs. Klan-whippings. [In Houston, an entire battalion of US “Buffalo” soldiers was hunted, with the aim of being shot dead, by the whyte populace, in vigilante fashion, after whyte Texans decided they didn’t like armed “colored” men in their town. And then in a one day “trial” — 19 soldiers who defended themselves were… hung. Holy sh!t, Paul. See at right.]

In sum, this goes back at least two centuries — since you think whyte protestors were treated worse… please do go watch all 12 hours of “Eyes on the Prize“, son.

Damn. Just… damn.

This Is A Life… To Emulate: Dr. Joel Breman — Travel Well; Travel Light!

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His daughter remembers his motto, during her high school years: “Adventure first, safety a close second.” recalls Johanna Tzur. She says her father encouraged her to do a high school year abroad in the Soviet Union at a time when few Americans traveled there. It would be interesting, he promised. And one more thing, says Tzur: “I remember him vividly explaining I was never to eat anything that couldn’t be peeled.”

In the year before his death, Breman was still teaching a course on infectious diseases at George Washington University and working on a textbook as well as a memoir. Here’s the NPR rundown of a wonderful life, in bio-sciences — and in fact, in one of his proudest moments, in the 1980s, he won the Order of the Leopard, from the government of Zaire, for his work in mitigating endemic diseases there:

…Peter Piot, a fellow disease investigator, remembers the exact date that he met Breman. It was October 18, 1976, and Piot, then a young physician and microbiologist, had come to the city of Kinshasa in central Africa (in current-day Democratic Republic of the Congo) to investigate a terrifying, deadly, nameless new disease. Breman, already 40 years old and with several epidemic investigations under his belt, was there working for what was then called the U.S. Center for Disease Control….

Piot says it was clear that the pilots dropping them and others into the remote epidemic zone never expected to see them alive again.

Once on the ground, Piot watched how Breman did his epidemiology. “He taught me that when you go into a village, you don’t just start talking about why you’re here,” Piot said. Rather, they went early in the morning, talked with the village elders and asked them how they’ve been. “And then, and only then, you start with your questions.”

Born in Chicago and raised in Los Angeles, Breman showed his talents and leadership early on. In high school he was student body president and a football player; in college at UCLA he was president of his fraternity and rowed varsity crew.

Breman graduated from the University of Southern California School of Medicine in 1965 and spent the next 11 years working on various diseases with the CDC and World Health Organization. He would go on to earn a doctorate in public health from the London School of Hygiene and Tropical Medicine….

Piot, Breman and others spent several months on the ground in central Africa. The disease they were investigating turned out to be Ebola, which at the time had a 90 percent death rate.

“It was super stressful,” said Piot. The team was sharing mattresses, working day and night, collecting data from people who didn’t necessarily want to see them. “But [Breman] remained calm always.”

By the end of the trip, Piot says he was bowled over by Breman’s equanimity, patience, kindness, respectfulness, and his ability and enthusiasm in telling jokes in both English and French….

A life well lived, indeed — is its own reward. Travel well, but do travel light Dr. Breman. Smiling out into the sunshine, with baby girls due in for a play date, tonight… it is well, with my soul.

नमस्ते

A Look At The $20-Million-A-Year Club, In Pharma CEO Compensation… [Would Include Amazon And Apple, Too]

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To be fair, Rob Davis reaching $20 million plus in annual compensation is primarily a function of the rising price of Merck’s stock on the NYSE (and that has been very good for all shareholders, when added to the very hefty dividends, paid every quarter, year after year — since at least the 1950s). You see, at the time these last grants of options and restricted stock were made, Merck was trading between $95 and $103 per share.

Recently Merck’s NYSE price was trading between $128 and $134 a share — up smartly from these latest grant dates. However, Mr. Davis’s cash bonus was decreased, as it has probably maxed out — in its “added carrot” appeal to him, given that he is up over 30%, on his stock compensation. But the board did bump up his salary to run a little ahead of the core inflation rate for the year. [Not that he would be, in any manner, worried about the rising prices of avocados — in terms of daily brown bag lunch affordability — mind you.]

All in, while I had complained for years that the con-man “Fast” Fred Hassan was vastly overpaid — for his uniformly terrible decision-making, at legacy Schering-Plough… I generally felt that Kenneth C. Frazier was fairly compensated for the unique skill set he offered Merck.

So too now, Mr. Davis — he’s matured as a leader since his early days at Lilly. That said, he lacks some of the charisma of a Ken Frazier or Roy Vagelos (perhaps the gold standard name in this arena). Here’s the details, from Fierce’s nice collection of proxy disclosures — as Saturday filler fodder:

…Merck CEO Robert Davis has cracked the $20-million mark in annual pay for the first time, putting him in an exclusive club of biopharma heavy hitters.

Davis, 57, who took over as CEO in 2021 and as chairman the following year, received a 9% bump in pay in 2023 to $20.3 million, according to the company’s proxy filing.

Davis joins Johnson & Johnson’s Joaquin Duato ($28.4 million), Eli Lilly’s David Ricks ($26.6 million), AbbVie’s retiring Richard Gonzalez ($25.7 million), Pfizer’s Albert Bourla ($21.6 million), AstraZeneca’s Pascal Soriot ($21.3 million) and Vertex’s Reshma Kewalramani ($20.6 million) in the $20-million-plus club for 2023….

Davis’s compensation increase in 2023 came despite a drop in his bonus from $4.1 million to $3.6 million. His equity awards however increased from $11.4 million to $14 million, while his salary was up from $1.54 million to $1.60 million….

Indeed, though — it is astonishing that the CEOs of these vastly profitable behemoth companies are just now catching up to what the CEO Jason Les pulled down, last year (last available disclosed total: 2022) at tiny Riot Platforms (revenue of under $100 million; never GAAP profitable), for losing over $2 billion life to date — and (did I say this part already?!) never making a GAAP profit from operations in eight long years.

Riot is a Bitcoin miner — like all the others, set to get crushed by the “halvening” — coming end of next week. [Accordingly, it has seen its stock fall from the mid-$20s, to a little over $9 on the NASDAQ, as of Friday.]

That THAT GUY makes over $20 million a year is absolutely…

I N S A N E.

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