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Ed Silverman’s Pharmalot: Sotatercept Will Be FDA Approved At Close Of Business Today…

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We had long ago (in September 2023) reported that the drug candidate had shown remarkable results, and had won priority review at FDA. Today is decision day, and it is a near certainty that it will be approved after tonight’s NYSE closing bell. This development portends to add, and add materially, to Merck’s revenue and profitability. This is likely so, because it is the only known approach to treating PAH, and as such, it is a treatment for a fairly rare blood vessel disorder — one which primarily presents in middle aged women.

The candidate came into Merck’s fold as part of the Acceleron deal in 2021. The company had said it expected PAH to be a roughly $7.5 billion market, by 2026 — when it announced that ~$11 billion M&A deal.

So… Rahway essentially took title to all of Acceleron’s R&D assets for about one and one half times the expected annual revenue of one of its drugs — starting tomorrow. That’s smart deal making. Here’s Ed’s very fine and long standing property, with the news of the day:

…The Food and Drug Administration is expected to approve Merck’s drug to treat a rare lung disorder called pulmonary arterial hypertension on Tuesday, making available a novel treatment for a deadly condition that’s long been challenging to treat.

In a large trial published last year, the drug, called sotatercept, exceeded expectations in significantly increasing the distance that patients could walk and cutting the risk that their condition would worsen, that they would die, and that they would need new treatments….

Now you know — onward, baffled at how a cargo ship flagged from Singapore — just starting a 27 day long journey… finds itself striking the Francis Scott Key Bridge in the first hour of its journey, collapsing the bridge like an “Iron Man” movie scene, and leaving at least seven cars with people in them in the water, in need of rescue. It seems someone wasn’t being… very careful.

नमस्ते

Q.: Why Is Hinderaker Carrying Putin’s Water? AGAIN?!

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The central message here — now that Putin today said it was ISIS-K (confirmed by CIA)… is that we shouldn’t — and can’t — trust Russian accounts.

I agree the men in court today were tortured; there is video of it.

And CIA is likely correct: they are ISIS affiliated.

But beyond that, Hinderaker (in a quest to look smart) is only carrying Russian water.

As with the early days of fighting in Ukraine… the main question is whether Hinderaker is even aware that he’s helping Putin.

I doubt Putin pays any of these hard right US chuckleheads… but you never know.

The goal may be to foment dissent about the rule of law, in the US — Putin turning lemons (the attack in Moscow) into lemonade.

And Hinderaker is… chuckling along, helping him.

Hey, Alabama: This Doesn’t Even Qualify — As Being… Just “Ordinarily Futile”. It’s In The Realm Of… Madness.

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This amicus brief brief is simply… preposterously wrong on the law.

Here, after six years of litigation, including several appeals in the Ninth Circuit, and at least one US Supreme Court decision, the state of Alabama proposes to intervene, permissively — because it doesn’t like that Tangerine will no longer be able to violate the law with his “policies” — if a consent decree is entered (assuming the unlikely possibility that he is elected again in 2024).

Riiiight. It has long been the law, that during the pendency of litigation involving agencies of the federal government, when a new Administration takes over, and regulatory or enforcement priorities shift in a lawful fashion, the government may settle cases.

Consider that the federal government no longer asserted (after about 1958) that racial segregation was a “social good“, after Brown v. Board. Or that the federal government made millions eligible for health insurance (after 2014), after the Supremes held Obamacare was lawful, in King v. Burwell.

But this amici group filing claims only now, all these years later, when it declined to enter the litigation at any trial court level — and just looked the other way — now it wants to try to thwart a consent order that would be binding nationwide on the humane treatment of undocumented persons, and asylum seekers. [In sum, it seems the right to undo things, without ever filing its own suit to establish standing in the first place — a hurdle it almost certainly cannot clear.]

Apparently, Alabama, Texas and Florida don’t believe the Supremes meant what they wrote, when they said that bedding and blankets and soap and toothbrushes and toothpaste are the bare minimum migrants — in many cases, children as well — are entitled to, under our treaties and laws.

This is a dead end attempt, to be certain — but I want to note the depravity of the people attempting it, from a few of the red state-houses, and Governors’ mansions.

D A M N.

Not In Any Sense… A Win. NY Appeals Court Still Has Trump In A… Vise. He Only Has Ten Days To Find $175 Million.

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Were one to believe/credit Faux, one might think he’s in the clear.

Pretty much the opposite is true. He still must find cash of $175 million within ten days. And he is still under the Monitor, while the appeal is heard. When we get to the merits hearing on the appeal — it is STILL highly likely he will owe over $500 million. All he’s done is buy ten days. Here’s the actual proof, not the Faux spin:

…[Trump parties must post,] within ten (10) days of the date of this order, an undertaking in the amount of $175 million dollars….

The aforesaid stay is conditioned on [Trump parties] perfecting the appeals for the September 2024 Term of this Court. The motion is otherwise denied, including to the extent it seeks a stay of enforcement of portions of the judgment (1) extending and enhancing the role of the Monitor and (2) directing the installation of an Independent Director of Compliance….

Damn. So he has ten days. Big deal. He’s still in a very very deep fraud laced (~$550 million plus) hole… in New York. Now you know.

नमस्ते

End Of March Amazon Check-In: False Claims Made In Smith Case — At NLRB / Re JFK-8…

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Enough digital ink — for the week — on mind-numbingly dumb legal theories from the Powerline boy’s club. So let’s look at some real federal law — some that matters. [In general, if I don’t mention one of the boys’ posts — it is not because it is correct… no, it is because… it is so silly, and wrong… that it merits no considered response. Now you know — as I’ve reminded the readership — about every three years, here — over the last 24 years. Onward!]

So… we note that Amazon is losing — and losing profoundly — in the JFK-8 “union busting” tactics cases, before ALJs at the NLRB in Phoenix (these cases do not get assigned to local judges, to avoid pressure from large employers — so Phoenix is the venue, but as we all well-know, Amazon has a major footprint in nearly every top 100 US metro area… sheesh).

In any event, the clear implication here is that Mr. Smith was in fact fired for union organizing activity — in manifest violation of the National Labor Relations Act. Do read the latest exceptions filed by the charging party, last Friday, before the NLRB… but here is a bit:

…This false record shows that Amazon did not follow their policy to counsel only employees whose UPT [unpaid personal time] hours fell below 15. Nonetheless, credibility determinations are not at issue when the records objectively show use of UPT time which contradict his payroll records. [Amazon incredibly] posits that the same week that Smith worked over 40 hours and doubled his usual hours worked, he somehow had bid on other shifts but did not show up. There is no evidence of that. The evidence shows that 10 UPT hours were taken from him in the week he worked double the hours he was supposed to….

This is a pretty egregious record, across dozens of facilities, and hundreds of current and former Amazon workers — that Bezos’ company actively violated, and violates, the law — in trying to bust up union organizing drives, by underpaid workers. Onward. More starting in April, as ever — on our monthly check-ins… smile.

नमस्ते

In Which Prof. Turley And Scott Johnson AGAIN Try (Impotently) To Make Murthy… NOT A Specious “Must Carry” Claim…

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Well… yet again, Scott is whining this morning, about how the Murthy arguments went at the Supremes, last week.

No amount of irrational shouting by these two jokers will be able to convert a silly claim against a private actor (for refusing to carry the lies and nonsense of another) for failure to hand out free megaphones… into a government censorship case.

These private actors are… for profit businesses. They make money from advertisers. They are not required to drive ad revenue away, by carrying racists’ rants on their sites. They are not required to reprint lies — like the Bakker colloidal silver ones… in the middle of a pandemic.

That is what the Supremes all agreed on, in Murthy, last week — at argument. Since the time of Reagan (1985), not even the then three/four monopoly TV networks were bound by “must carry” FCC rules. [They are long gone as a restriction on first amendment rights not to associate.] And the social media arena hosts at least 28 providers I can think of in two minutes. There is — in sum — no monopoly case to be made.

Hilariously — the hard right (private actors, all) even support two of their own Gag.com… and the ironically named “Truth Social“. Let that be (every gallon) the cesspool… these idiots claim to want. I. Don’t. Care.

I’ll never visit — and the per share price of its newly public parent is… cratering, as people realize… Tangerine is going to have to sell most of his $3 billion nominal stake — to avoid being… insolvent, after the rest of the hush money, and assorted other civil and criminal (felony) verdicts come in.

Flawless!

Out.

Tangent: Come Thursday, Highly Unlikely That SBF Gets Less Than 15 Years…

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Since we are on the topic of crime and punishment this morning — let’s get this out of the way: there is no way that SBF… skates. Not a chance.

Nope. There is almost no chance he won’t see a sentence at least 20% longer than Elizabeth Holmes. He will learn his fate at a hearing this Thursday morning, in federal court, in Manhattan.

While I don’t think 50+ years is likely, I do think 25 is on the table.

I won’t repeat what the goofy prediction market bets at Polymarket say, but the betting is clustered between 20 and 50 years.

His complete lack of remorse — continuing to mislead — even on the stand… means the mere fact that there have been recoveries in bankruptcy… won’t count for much in reduction of sentence credits, I predict.

Onward.

If It Does “Send Tremors Across This Country” — To Simply Enforce The New York State Fraud-Seizure Laws — Evenly, Without Fear Or Favor… SIGN ME UP!

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The moron spawn of Tangerine apparently told Faux over the weekend… that continuing the 93 count, four indictment prosecutions of his pops. . . is going to “send tremors” across the nation. [He is clearly trying foment a new insurrection, when the now largely inevitable convictions come — based on the evidence already available.]

See, Eric — how this works is: “you don’t do the crime, if you can’t do the time.” But from Faux, I’ll quote only the opening, and last sentence of their “report”, thus:

…Eric Trump railed against the massive half-billion dollar bond his father must secure in the New York civil fraud case by Monday’s deadline or risk having his Empire State assets seized by state Attorney Gen. Letitia James….

If Trump is unable to secure the bond, Attorney General Letitia James and her staff stand ready to seize his New York properties….

Yep — today’s the day. Couldn’t happen to a nicer guy. Onward… grinning.

नमस्ते

Hinderaker Clutches His Pearls, And Falls On His Fainting Couch — Out, Cold [Almost].

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This is what a supposedly “learned” conservative perspective now offers:

He’s throwing a tantrum — stamping his tiny feet — because Hollywood A-listers are doing an audio feed / pod-cast, one that consists solely and simply of… reading Tangerine’s indicted crimes, into the public record.

Liam Neeson, Glenn Close, Peter Coyote and Renee Elise Goldsberry are reading from public record court filings, ones made by the US government (and the State of New York). Poor lil’ John feels it is… abusive?!

Seriously?!

Man — what a snow-flake he’s become — in his… dotage.

Out.

Live Coverage Tomorrow — Of Soyuz 25 Docking At ISS — And Crew Transfers…

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We’ve taken a bit of a special interest in this one — ever since the first launch scrubbing (last Thursday morning), at T minus 21 seconds. It is now all normal, and in orbit, sailing flawlessly toward tomorrow morning’s docking.

Here’s the latest, from NASA:

…Dyson, along with her crewmates Roscosmos cosmonaut Oleg Novitskiy and spaceflight participant Marina Vasilevskaya of Belarus, will dock to the space station’s Prichal module about 11:09 a.m. on Monday, March 25, on the Soyuz MS-25 spacecraft.

Docking coverage will begin at 10:15 a.m. on NASA+, NASA Television, the NASA app, YouTube, and the agency’s website. NASA also will air coverage, starting at 1:15 p.m., of the crew welcome ceremony on NASA+ once they are aboard the orbital outpost. Learn how to stream NASA TV through a variety of platforms including social media.

When the hatches between the station and the Soyuz open about 1:40 p.m., the new crew members will join NASA astronauts Loral O’Hara, Matthew Dominick, Mike Barratt, and Jeanette Epps, as well as Roscosmos cosmonauts Oleg Kononenko, Nikolai Chub, and Alexander Grebenkin, already living and working aboard the space station….

Now you know… Zoom call with the great grown kids — in five minutes here… smile.

नमस्ते