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Category: Uncategorized
Breakthrough Designation: Moderna + Merck’sKeytruda®, In Melanoma
This is outstandingly good news, and as the smaller company by market cap, Moderna ought to see the biggest pop (after the noise of the current poor quarter is cleared out of the baffles) — but it will be nice for Rahway, as well. Cutting risk of death by 44 per cent is… just a grand slam.
As ever the prices will be steep, but the outcomes… may approach cures. Okay — here’s the dawn’s great news — without additional delay:
…The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to Moderna and Merck’s personalized mRNA cancer vaccine mRNA-4157/V940, in combination with Keytruda, for the adjuvant treatment of patients with high-risk melanoma after complete resection.
The FDA’s decision was backed by data from a phase 2b trial, dubbed KEYNOTE-942/mRNA-4157-P201.
In the study, the combo helped cut the risk of recurrence or death by 44%, versus Keytruda alone, in patients with melanoma, a type of skin cancer….
Yep — excellent news, indeed… the Merck portion of this combo, several years ago — gave former President Jimmy Carter at least seven more very healthy years, completely free from melanoma (and a variant that had metastasized to his brain). Now you know… how lucky we are to be alive in this era. Smile.
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Apple Is 12 Years In — But We’ve Been Covering The Effort For Roughly… Six. Med Devices Are… Hard.
To be sure, the juggernaut of a company — a category killer, really… is still probably four years away from an FDA filing, and maybe three more away — from approval to sell, in the US.
Still — this is good progress. It points up just how hard the science of “medical device” hardware really is. Here’s the progress after six years: finally, proof of concept. It can be accurate, in the wild. That’s step one.
…Apple’s moonshot project to use the Apple Watch as a noninvasive glucose meter has reportedly reached a “proof of concept” stage, but will still take years to come to market.
Being able to monitor blood glucose levels without any invasive procedures has regularly been rumored to be coming, but research was expected to take many more years.
According to Bloomberg’s Mark Gurman, it will still take time to become part of the Apple Watch, but the research has passed a significant milestone. Unspecified sources, seemingly within Apple, say that after 12 years they have reached what they call a proof of concept stage….
But mark my words — when it does clear FDA, the old line med device firms will… wheeze and cough… as even tiny pin-sticks become a thing largely of the past. And it is likely many more will get treated, if they don’t have to face a jab twice a day. And that’s a very… good thing. Smile….
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A Brief Look — At The Current State Of Potential Marburg Vaccine Candidates, From GAVI… For Guinea Outbreak 2023
This is just a very quick update — on the state of the play, in getting potential Marburg vaccine candidates into field trials, in Guinea — before the outbreak ends.
Here’s the latest from GAVI:
…So far only the Sabin vaccine has completed phase 1 trials.
The IAVI candidate is ready for phase 1 and PHV has completed pre-clinical testing. Janssen and Auro are not actively being tested currently.
WHO’s plan for testing vaccines would be similar to the approach with Ebola: ring vaccination targeting high-risk populations. None of the vaccines may even get to a clinical trial – ideally, quarantine would end the outbreak before a vaccine dose could be administered….
That is all. Now you know… steady snow here now…. smile.
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[UX2: Rejected By The Clerk Of Court!? — Now Avail.] In The “You Can’t Teach Some People… Anything” Dept.
SECOND UPDATE –@ 9 PM EST — The Team Tangerine documents are back online in NYC tonight, and yet remain every bit as turgid as the first two batches. In addition, the able Assistant NY AG asks the judge to no longer blithely accept Trump’s foot dragging conduct, in waiting to the close of discovery, to first schedule his own witnesses, for deppos — people he’s known about for years and years. This should prevail. End, second update of the evening.
Not ten minutes after I accessed, linked and quoted the below… all 25 or so Answers by Tangerine entities… were inactivated by the court clerk, electronically.
I did not download the PDF — but I saw it, at page 48, for a few moments — as below. This one is going to get… hot, and rapidly. [I will leave my broken link below — as that is where it was — for a moment.] Stay tuned. End, update.
We earlier mentioned that Tangerine’s civil NY fraud lawyers were repeatedly warned not to waste time repeating arguments he’d already been overruled on by the able NY State Judge Engoran, in Tish James’ long running NY AG suit for frauds — against him and his entities.
Ahem. He’s now refiled, for a THIRD time — and… we see this, at page 48, in Tangerine’s “answers” — in direct defiance of Judge Engoran’s explicit law of the case, ruling Tangerine is barred from making arguments he already repeatedly lost on — like that the NY AG has no power to enforce the law against him, as written:
…The Attorney General has no authority, capacity, or standing to bring a claim under Executive Law § 63(12) based upon the facts alleged….
What an idiot. He, and his NY lawyers may well get jailed for a bit, for contempt now — behind this garbage. Just some trivial housekeeping, on a snowy afternoon. Grin… we will keep you posted. But he just filed this garbage (again!) this afternoon.
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Hayward Offers The Best Kind Of Help… The Kind GOP (Or Dem.!) Money Cannot Buy — But In Favor Of Democratic 2024 Candidates.
This is so ironic, as to be note-worthy — all on its own.
The dolt Steve Hayward thinks the lower part of the chart at right is good news for the GOP.
It is… the end of days.
There is NOT A SINGLE Democratic candidate that we might even remotely plausibly run… that would not beat Tangerine, head to head. [Candidly, DeSanits presents a slightly tougher path to victory, for at least one or two of the likely potential Democratic 1600 Penn. nominees. The issue (I think) will be finding someone who is younger, and at least as vital as he appears to be.]
So… Hayward, albeit unwittingly — cheers us Democrats on — by saying it will be… Tangerine. Sure, much could shift, by 2024 — but his base (the 33% or so of the GOP that is getting MUCH older, more embittered, almost all-whyte, and anti- all things 21st Century… likely… will not — some will die off in the next two years, but not that many).
So — we expect at least eight more years of the White House in Democratic hands.
Cheers, boys. Grin.
NASA Working On A Slight Glitch — On One Of Parker’s Instrument Packs, Before March’s 18th Close Dip…
Well… because of the relative positions of the Earth, Sun and Parker… we will have to wait a week or two to send it new radio updated software packages — but that should solve the problem.
And so, it is unlikely it will be any issue during Parker’s 18th close dip past the Sun.
Here’s the latest NASA blog entry, on it:
…An instrument on NASA’s Parker Solar Probe was powered off by the spacecraft autonomy system on Feb. 12. It happened during the application of an approved flight software patch to the Energetic Particle Instrument (EPI-Hi). The instrument team determined the instrument was power cycled prematurely before the patch was completely loaded.
The instrument will remain off for several weeks as the geometry between the spacecraft, Sun, and Earth currently prevents a good uplink. The EPI-Hi is expected to return to normal operations after this blackout period, before the spacecraft begins its 15th close encounter with the Sun on March 12.
The overall spacecraft remains healthy and is functioning as expected and the operation of other Parker instruments has not been impacted. . . .
Whoosh — what a time to be… alive! Now you know — and this lil’ speed merchant is now officially the fastest human-made thing… ever, in space exploration. Grin… onward, to March — as a light snow falls here, this morning….
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[U] Already, One Night Later — I Must Correct Paul Mirengoff’s… Egregious… J6 Comm. Lies.
I know. I know.
I said I wouldn’t look — but a friend just showed me that Paul made this BS claim (yet again, as in 2021!):
…But what it could have done is permit members selected by the House Minority Leader to participate….
In point of fact, the GOP members all refused to participate. Paul knows it, too.
Updated: And for the idiots at Powerline, what this means — and the significance of it — is that to a person, the GOP-Congress-Critters realized that if they were on the Committee, at least some of the effort would have to involve gently admonishing “dear leader” Tangerine, just based on the video already made public.
So, instead of potentially provoking dear leader’s well-known ire — against their re-election prospects… they all chose NOT to do their sworn duty. They… sat it out.
Abdicated the role the voters had handed to them. And now… they (and he) complain, about not being included?! J the F-ing C.
What an utterly churlish… Ass-hat, is Paul. Okay. I’ll likely fall… silent now, on Mirengoff, again.
Out.
Roscosmos Hopes To Launch Its “Lifeboat” Mission, To The ISS, This Friday. Stay Tuned.
It is expected that by Friday, Russia will have sent a rescue Soyuz capsule space-ward, toward the ISS, in orbit. . . to bring our guy, and two of theirs, safely home.
The other damaged Soyuz module we previously discussed here will be allowed to de-orbit via remote radio commands — and in a controlled fashion, then burn-up harmlessly, somewhere over the open Pacific Ocean. It has been deemed unsafe for human transport.
Here’s NPR’s take on the latest developments — do read it all:
…Russia’s space agency is preparing to launch a mission on Friday to provide a ride for two cosmonauts and one U.S. astronaut who are on the International Space Station without a designated ship to get home.
The spacecraft that brought the three crew members to the ISS in the fall later experienced a leak in its radiator cooling loop, and officials from both countries had to develop a new plan to get the trio back to Earth….
[Separately, an] unpiloted Russian cargo ship called Progress 82 that was docked at the space station suffered an unexplained depressurization of its coolant loop on Feb. 11.
The leak on Progress 82 was not connected to the planned rescue mission, but it prompted engineers at the Russian Mission Control Center near Moscow to investigate why the cargo vessel lost coolant and postpone the launch of the MS-23….
The new Roscosmos plan remains 5X5, all-green, for a launch this Friday — but should it encounter issues, SpaceX has said it has a vehicle at the ready, which could accommodate up to four astronauts / Cosmonauts in a pinch.
To be sure, there is plenty of food, water and supplies onboard the ISS for several months yet… even if both of those vehicles were to become unavailable. So. . . no worries, other than why several older Soyuz era designs are experiencing coolant leaks once in orbit.
Onward, and now you know (yep, Paul Mirengoff is smarter than the other three, combined).
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[U] It Must Be Said: Paul Mirengoff Out-Thinks ALL The Powerline Boys.
Updated — 02.21.2023: To be clear, I likely won’t ever comment on what he and his writing partner have written there — nor, perhaps even ever look in on it again. I. Just. Don’t. Care. [This all started as a rebuke to John Hinderaker’s lunacy. So, I’ll fall silent again on Paul Mirengoff — but it is funny that his remarks on Cal Coolidge were far more cogent and thought provoking than old Steve Hayward’s were. And they spoke at the same confab, on it — at the same time, in DC. Hilarious.] So… don’t assume I’d agree with even one syllable he writes there… as I likely would not. End, updated portion.
I just truly randomly happened across the fact that he’s been writing a Substack for nine months.
I think (based solely on a quick scan) I’m unlikely to find more than one per cent of it… even remotely persuasive, but it is clear that he thinks more broadly — and tackles far more issues (most of more weight, to be sure) than Powerline does, since his departure.
It may well be, therefore — that he was the brains (such as they were) there.
And that now, in hindsight — given a view to his work, since… explains a lot.
I still think he’s badly mistaken about much of what he writes, but at least it is not 90% pure drivel, of no moment.
W I L D.
