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GSK Bought A Cough Candidate — And Is Now Redesigning Its Clinical Trial, After “Going To School” On Merck’s Difficulties At FDA…

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First — as to the Merck gefapixant candidate review at the FDA Advisory Committee two weeks ago: it obviously only covers the potential US market. Merck’s cough drug, gefapixant (branded as Lyfnua®), is already on the market in the EU, Japan and Switzerland — with what must be called… only middling uptake.

And some of the reticence Merck encountered at the Advisory Committee then, is FDA advisors (rightly, in my view) predisposed toward only green-lighting medicines that show a measurable clinical, real world benefit — given the price points at which nearly all new medicines are now launched.

FierceBiotech has done a great job explaining how the “business” of smarter clinical trial design can lead to differing outcomes, on two (chemically) very similar drug candidates — at FDA. Do read it all, but here’s a bit:

…[T]he [GSK new clinical trial features] a central adjudication that ensures patients in the trial are in fact experiencing chronic refractory cough. Then, the trial is enrolling only the most severe patients….

“Because as you get to lower cough rates [as was seen in the Merck trial], it can be a bit idiosyncratic as to what’s the mechanism causing the cough, whereas patients with more severe high cough frequency typically are those that have cough generated via the neuropathic pathway, which is where camlipixant works,” Miels explained.

[B]eing first, Merck also had to contend with the fact that the FDA had no regulatory precedent in the indication. The agency noted it had “limited experience with the endpoints used in this program.” So Merck, and now GSK, are treading new regulatory ground. The FDA has not officially ruled on gefapixant but is expected to do so by Dec. 27….

We shall see — but Merck may have to seek a secondary end-point/trial redesign, in order to clear FDA. And GSK may still be over a year away from getting its trial to a point where the FDA staff can review it. So this is a longer term horse race, for the US market to be sure.

Onward. Ever… onward.

नमस्ते

[U — Double Shot, Of Hayward Idiocy!] Yesterday, Steve Offered ANOTHER Monumentally STUPID Chart. Ugh.

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Yesterday, Steve tried to tell us, based on very dubious research, that US women are “deadbeats” — on their college loans — at about a 20% higher rate than similar men. They take 20% longer to repay (let’s just pretend that something in the 10% to 20% range might be defensible, on more rigorous / real data — for the sake of argument, at least).

Gee, Steve — didn’t you know that the average college educated woman makes about 20% less than the similar average man does, to this very day?

Of course he did. He’s just this malignant — as a sexist loser.

What a putz. Yes, that could explain why it takes them 20% longer to repay, you malignant moron.

Pew research offers us the reality, to this very moment:

…In 2022, women with at least a bachelor’s degree earned 79% as much as men who were college graduates, and women who were high school graduates earned 81% as much as men with the same level of education….

And all of that is BEFORE he purports to chart a look at race and ethnicity — where there are (at least as reported in his data) similar disparities. Also largely explained by earning differences, on average — but with the confusing variable that proportionately more people of color and of limited means end up borrowing from FOR PROFIT student lenders, many of which charge over 11% annual interest, once a student misses a single payment. [In the data, we would also note that on average college educated Asian-American men earn well over even the whyte male average — a tech effect, perhaps… but that explains why they are paying down fastest of all groups he purports to cover. Sheesh.]

And in many cases, the student loan can approach a 20% interest rate. These for profit shops use the FACT that no one may discharge student debt in bankruptcy… to run essentially pay-day loan scams, under cover of law.

So yeh — Steve Hayward? He’s a… putz.

UPDATED –Friday Night, Late: O M Gurd. His Friday yutz chart purports to show that immigration will be an issue that gives the GOP the lead to 1600 Penn, in 2024.

Poppycock. If the tick up this year means anything, Steve — please explain why for all eight years of Bush 43 / Cheney (2000 to 2008) it was at historic highs, almost at 50% of America supposedly dissatisfied — that too many immigrants were arriving? And why — through about six of the eight Obama years, it was falling, and generally trending below 40%, on the “dissatisfied” dimension.

And now… all it has done under Mr. Biden, is tick back up to just under 40%.

It was only Trump’s lawlessness that beat those numbers down, for about three years.

And — confidential note to Steve: College educated independent suburban women… DON’T vote for lawless dictators with (likely, by then) felony records — as a rule. Especially ones who relish trying to… “grab them by the p*ssy“. All while demanding that this same crook be put in charge of controlling / regulating their uteruses…? Yeh. Uh huh. Ride the lightning, son.

Cheers.

Out.

And Texas Just Lost, On The Floating Razor Wire, In The Fifth Cir. — The Federal Agencies May Immediately Drag It Completely Onto The Texas Shore Of The Rio Grande…

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This SECOND opinion of the afternoon — a snowy Friday “double whammy” — out of the very conservative Fifth Circuit… is a clear warning to Gov. Abbott that he will ALSO lose, in the Fifth, on his odious land based lawless razor wire barriers. [See immediately prior post.]

The river case, along a stretch called Eagle’s Pass — of the Rio Grande… has now been decided on appeal. The trial court was correct in ordering the barrier dragged immediately out of the water, at Texas’ expense, and dumped on the Texas side shoreline, in a fashion that won’t endanger human life.

This is, in sum, a complete repudiation of Abbott’s multi billion dollar waste of Texas tax money called “Operation Lone Star”. [It might have more accurately been called “Cruelty to The Helpless — and Graft for Texas-Sized GOP Donors / Construction Firms.”] Do read it all — it will control, in many respects, the outcome in the land based razor wire barrier case. The MAGA GOP of Texas could not have suffered a more complete set of losses, at the border, over the last two days… if it had intentionally TRIED to lose:

…In July 2023, Texas, at the direction of Governor Greg Abbott, installed a floating barrier in the Rio Grande near Eagle Pass, Texas. The United States filed a civil enforcement action against Texas, alleging that installment of the barrier violated the Rivers and Harbors Appropriation Act of 1899 (“RHA”). The United States moved for a preliminary injunction, which the district court granted, ordering the defendants to cease work on the barrier and to move it to the Texas riverbank. Texas timely appealed.

This court entered an administrative stay. Finding that the district court did not abuse its discretion, we DISSOLVE the administrative stay and AFFIRM….

In [a federal agency engineer’s] declaration, he indicates that the Corps “were unable to determine, among other things, the exact methods of construction and whether the floating barrier was sufficiently anchored to ensure it remained in place,” as well as “any overall effects from the floating barrier on public safety, use of the Rio Grande in that area, and other public interest factors.” Finally, “because no information was submitted for project evaluation and potential permitting, it is unknown if the structure meets engineering standards to withstand predicted high flows. Should segments of the structure, or the entire structure, become unmoored from its location and travel downstream, further risks to navigation and safety could reasonably be assumed.” This is particularly troubling considering the August 15, 2023, declaration of the United States showing that nearly 80 percent of the floating barrier had drifted out of alignment and into Mexican waters.
The ambiguity and concerns surrounding the impact of the floating barrier, which have not been properly evaluated by relevant agencies because of Texas’s unilateral action, support the grant of a preliminary injunction….

Of course, this means far fewer asylum seekers will risk death by wading into the Rio Grande — a course of conduct allowed by our treaties with Mexico (no matter how much the MAGAts lie about it only being “allowed” at designated ports). This is the law. We respect it. Full stop.

नमस्ते

Update: The State Of Texas Now Wants A Largely Preposterous “Emergency” Injunction, For All The Same Dumb Reasons It Just Lost On, “Regular Way”… Yikes.

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Well… this would just be… comical — except that it wantonly wastes Texas taxpayer dollars on frivolous, vexatious motion practice.

The lawyers for Gov. Abbott now seek an emergency injunction, during its interlocutory appeal of the loss, yesterday… as to the very same injunction. Cra-cra.

USDC Judge Moses, and more importantly, the Fifth Circuit, will not grant it. The federal agencies’ views on the matter, just now filed… will (as before) prevail:

…Texas’s requested injunction would also increase the chances of harm to migrants. Specifically, it would prevent Border Patrol from being proactive to avert emergency situations before they arise. Given Texas’s own acknowledgement that “human life is paramount,” Hr’g Tr. at 28, ECF No. 37, and that “[p]rotection of life is first,” id. at 79, it is difficult to understand how insignificant costs in Operation Lone Star’s multi-billion dollar budget override those interests. See Defs.’ Supp. Br. at 15 n.4….

[Moreover,] the costs to Texas of having to repair cut wire [Ed. Note: in the highly unlikely event that Texas wins in the Fifth Circuit — estimated at under $1,000] are significantly less weighty than the harms to the federal government from an injunction impairing its ability to enforce the immigration laws and prevent loss of life. Moreover, Defendants were seeking the restoration of the status quo — not a limitation on the other party’s conduct, see Boire v. Pilot Freight Carriers, Inc., 515 F.2d 1185, 1194 (5th Cir. 1975) (“[T]he status quo to be preserved is the last uncontested status which preceded the pending controversy.”)….

Now you know. The “more common than thought rocky worlds around larger solar mass disks” discussion will wait for a more sanguine Saturday morning now. Smile.

नमस्ते

Hinderaker’s Chase… For The… Money. Musk’s Money. Hilarious.

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For a month now, John has been rabidly pro-Israel — to the point of calling for the Gazans to be “eradicated”. That was the word he used. And he regularly conflates “Palestinian” with “Hamas”. There is some overlap — but it is not a circle, in the form of a Venn diagram. And he knows it. But it feeds, as ever, his chasing of hard right elements in the Jewish community — ones that might send him… checks.

But suddenly, this morning — Hinderaker sees an opening to curry favor with the check book of Elon Musk. [Not that the guy even knows Powerline exists, mind you — nor that he would care, if he did know.]

But John, ever being John — is just “having a sad on”, that he too is suffering readership and funding declines, after supporting Tangerine — and racism — for a decade.

And it is all because Hinderaker imagines he is like Musk — and a chaos agent in his own right. Precious. And ironic.

[From here, I will simply repeat mine of early this week — when Musk went on his apology tour. Both he and Hinderaker… can’t figure out what they believe in — other than money, of course. Charming.]

Dateline 11.28.2023 — Well… when you can’t read the room… you end up spending a lot of time doing damage control, and apology tours. That is Musk’s life now.

Couldn’t happen to a nicer guy. Here’s the NYT on it all, and a bit:

…Elon Musk traveled to Israel and met with Prime Minister Benjamin Netanyahu on Monday, touring the scene of a Hamas attack in a visit that appeared aimed at calming the outcry over his endorsement of an antisemitic conspiracy theory on X, the social media platform he owns….

Dozens of major brands suspended their advertising on X after Mr. Musk this month agreed with a post that accused Jewish communities of pushing “hatred against whites that they claim to want people to stop using against them.” The flight of advertisers threatened to cost X tens of millions of dollars, and the White House denounced Mr. Musk for “abhorrent promotion of antisemitic and racist hate.”

On Tuesday… Mr. Musk wrote on X that “actions speak louder than words.” Wearing a flak jacket, he toured Kfar Aza, an Israeli kibbutz where dozens of people were killed during the Hamas terrorist attack on Oct. 7….

So it goes, with Elon — I truly believe he is on the autistic spectrum, or said another way, just this out of touch, on the emotional intelligence scale. That does NOT excuse any of it, as he ought to get educated before he speaks — but this is now a nearly decade long pattern of his: blast out something idiotic (or worse); then either deny it happened (cave rescue insults) or end up on an apology tour — as here.

Onward.

Well — Time Does March… Ever Onward — Travel Well, Sandra Day O’Connor…

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The times — they are… a’ changin’… the passing of a guard, from the Cold War era, indeed. She opened the door for Notorious RBG. And set the table for the Wise Latina Justice, and for Elena Kagan. She was also the inspiration for literally several dozen federal lower court judges, now ably serving on the benches around the nation — as well as state and municipal ones. [Her cleverly-couched aid, in the subsequent shaping of, and semi-stealth version of… protecting… Roe v. Wade, for decades, has been the subject of several books.]

From the estimable Amy Howe, then at the SCOTUS Blog, a bit:

…Sandra Day O’Connor, a self-described “Arizona cowgirl” who made history as the first woman to serve as a Supreme Court justice, died on Friday in Phoenix, Arizona. She was 93.

The cause was complications related to advanced dementia, probably Alzheimer’s disease, and a respiratory illness, the Supreme Court announced….

Chief Justice John Roberts said in a press release announcing O’Connor’s death that O’Connor “blazed a historic trail as our Nation’s first female Justice. She met that challenge with undaunted determination, indisputable ability, and engaging candor. We at the Supreme Court mourn the loss of a beloved colleague, a fiercely independent defender of the rule of law, and an eloquent advocate for civics education….”

Also like [Ruth Bader] Ginsburg, O’Connor was unable to find work at a law firm even though she was at the top of her class and an editor of the law review [at Stanford]. One California-based firm, Gibson Dunn, did offer O’Connor a job – as a legal secretary….

Travel well, but travel… light, SDO. Smiling a sad smile, even though we disagreed strongly on several topics, she was a true champion — for women’s rights — at least insofar as that notion was understood at the time, under Ronald Reagan. Onward.

नमस्ते

Well — After The End Of February 2024… Additional Delays In The Multi-Billion Dollar “Merck v. Merck” Name Fight Will Be… Over: USMJ Hammer.

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We have our answer (teed up by the post of last night). This adjournment of the final pre-trial conference… is the erh… FINAL one.

There will be no more delay allowed. If the parties genuinely intend to settle — they will have to do so while meeting all the remaining trial calendar dates — in the USDC for the District of New Jersey. Here’s that order, just entered this morning:

…TEXT ORDER: The Court has reviewed the parties’ November 30, 2023 joint letter [D.E. 235].

Defense counsel’s request to adjourn the Final Pretrial Conference is granted. The Final Pretrial Conference shall take place in-person on February 29, 2024 at 11:00 a.m. in the Undersigned’s courtroom. There shall be no further adjournments for any reason.

So Ordered by Magistrate Judge Michael A. Hammer on 12/1/23….

Now you know — onward, to a snowy weekend ahead — it is increasingly… the Season, too… with only three weeks until the desert heat and sunshine. Grin.

नमस्ते

Mirengoff — Nominally About Kissinger — But Really About… Himself, And The Powerliners.

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This is hilarious.

Mirengoff says this was 2008. Which scans, because Kissinger’s political capital was at its nadir — Bush 43 was feckless; McCain was certainly going to lose to Mr. Obama — this was clear by early Summer of that year. And… Nixon/Reagan style dirty war political thinking was all but vanishing from the Earth.

We were about to try again to become the beacon on the hill — the second Camelot, as an Obama presidency promised so much new hope. [That all of it came up somewhat short of the wildest parts of the dream really doesn’t matter now. Much was achieved. 45 million Americans have basic health care. That alone is… a victory for a century.]

So — Kissinger’s theories on things… had become just about as relevant as a wall covered with buggy whips, for sale in the center of the DC Metro in 2008.

And so… he appeared at a Powerline dinner, and we are told, observed a debate among these village idiots about… wait for it! — whether to bomb Iran. Mirengoff reports that Kissinger looked “bemused” by the debate. Perhaps it was his gin, kicking in, and he was glassy eyed — or perhaps he was thinking… how far his star had fallen… listening to this drivel.

In any event, under Trump he did have a few last, fleeting flashy moments of public appearances, mostly for show (by the GOP regulars, trying to legitimize the lunacy of Tangerine and all he stood for).

And my point, then: Paul, John and Scott and Steve (who likely hadn’t joined yet)… forever think of themselves as being important in national political conversations, when they really aren’t even relevant in mainline conservative ones, any longer. They are so filled with racial invective, and bias against anything other than evangelical X-tain talking points… no one of consequence listens any more — to them.

Just as it is sure Kissinger was NOT listening that night, to these mental midgets.

And, in truth — very few were listening to Kissinger himself, any longer. It was an Island of Misfit Toys moment — if ever there one was.

Finally, to correct Paul — Mr. Obama disdained Kissinger, as we all did and do… for his war crimes, covert wars and genocide, all committed in our name — without any of us (or at least not most of us) knowing, until many years later.

Exhibit A? Cambodia, at left, and top left, above. Anthony Bourdain wanted to beat Kissinger to death with his bare fists — if he ever met him, based on what he did to the Cambodian people in our name.

Sure — he was… a crafty sociopath — much like a latter day Goebbels, behind the 1960s and 1970s GOP scenes. Sort of a thinking man’s Dick Cheney.

Out.

A Return To The Power Alley: Small Update — On The Merck v. Merck Lanham Act Name Spat [Trial Date Now Not Earlier Than Late 2024]…

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Pretty much as we earlier guessed, at least one of the parties’ lawyers (the one for German Merck) is definitely slow walking the pre-trial conference date, probably because there have been renewed (but on-and-off) settlement discussions. But the federal district court in New Jersey will not let that cha-cha go on… forever. [Fairly recent prior backgrounder — specifically about trial guesses, here. But overall,the coverage hits hundreds of posts, over 14 years minimum, here.]

Earlier today, both sides explained that — for various reasons, instead of holding a pre-trial conference in the first days of the New Year, either the second week of February — or the last week in that month (2024) — may be the only next available date.

Somehow, these lawyers have forgotten that the court itself suggested that its own very busy docket might mean some slippage on the trial date, which he was trying mightily to avoid.

[That said, it is baffling to me that a trial lawyer would say he doesn’t have to say why he’s unavailable for two weeks in Asia, in the middle of February — given that he’s known about these dates, in a multi-billion dollar piece of global litigation, no less… for a year minimum, and possibly closer to… a decade.]

In any event, we report on the letter solely to predict that we aren’t likely to see a 2024 trial date — if we ever see one. I’ve thought for a decade that these claims are the sort to settle — not try, in a courtroom — even a fine one like the NJ USDC. The stakes are far too high — on both sides. Figure it out, guys. Out. Grinning… again.

नमस्ते