Author: condor

Tangent: We’ve Learned Much More, Today — About What Mr. Shkreli Has NOT (Even As Of Tonight!) Provided To FTC Per Prior Orders.

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So, with my immediately prior entry — we see the very pinnacle of what’s right about life sciences leadership — and now… we see… the very bottom, of what is wrong with at least one embodiment / incarnation… of it.

Yep. This is going to end badly, for Mr. Shkreli. [And almost word for word in the way we predicted, too.]

The FTC just weighed in, to put the lie to Martin’s claims about “one missed voicemail” — and his otherwise “full cooperation”.

Obviously, the truth is a very long horseback ride away from where Martin left it.

And so, the FTC just said so by way of a formal, filed reply, to USDC Judge Cote.

But Exhibit D to that filing (mostly redacted and sealed)… contains the best bit, at the last unredacted page, at the bottom.

There we read that a Delaware LLC called “SHKRELI FAMILY HOLDINGS LLC” has a controlled company in its family. That controlled company (likely a wholly-owned subsidiary) is called… yep: Druglike, Inc., a Delaware corporation.

This, after Martin filed a sworn pleading about ten days ago in Manhattan saying he has no position, or ownership interest in Druglike. But Exhibit D also includes his employment offer letter / contract from Druglike, dated as of October 14, 2022.

Now, it is possible, given the various redactions and sealings, that only his family members (and not Martin himself) hold legal title to the shares of Druglike, through that LLC.

But his injunction was crystal clear — his effective beneficial ownership via family members and employment letter signed by one Marek Biestek (for Druglike), make out a plain, and likely continuing, violation of the terms of his court orders in the FTC matter.

Damn.

The main question now is what will Judge Cote order as remedies — sitting as a court of equitable contempt.

Does she send him back inside for a couple weeks — to make sure he remembers who is boss?

We shall see.

नमस्ते

Hinderaker “Doesn’t Know”… Much, Actually.

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Tonight… he opines that children are getting permanent top and bottom surgery… for gender dysphoria “often” in America, after 2015. [That’s a very stupid lie. There are ~60 million school age (pre-18; after that, it is an individual’s choice matter) children in the US. There were two surgeries (at 15, and 17… last year in Florida); nationwide there were fewer than 180-200. And fewer than 1,000 began taking hormone therapy. So… that’s 0.0003 of one per cent of all kids that got intervention of any substantial kind.] Incredibly, Florida’s DeSantis is pushing for new laws… based on two surgeries, out of over 3.2 million school age kids in Florida. Two.

Of course — and in any event — in his next sentence, he admits he doesn’t know much. About any of it. Obviously.

He ought to… shut up. We all know he’d be the first in line — to tell all comers to “butt out” if a set of hard right X-tian parents refuses to vaccinate their children.

But (in his upside down world, at least) parents are not allowed to choose, with their teenagers’ input — about gender surgeries?!

John?

John?

End, mission transmission.

Now Fully Extricated From Rahway, Kenneth C. Frazier Signs On To Be Chairman Of… Transcarent

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You knew he would not stay fully retired for long — and to be fair, this is a chairman of the board of directors role, not an operating, hands on, position. [But we all know he has only one speed: full, ahead.] And anyone who has been paying attention here knows I admire just about everything about him. A great guy, and a stellar leader.

So, the new-ish health delivery via connected device company is very lucky to have him. And the team has about three years of fully-funded capital raised, as runway — to get it into the black. Here’s the scoop from Axios:

…Health care pathway architect Transcarent named former Merck CEO Kenneth Frazier chair of its board of directors….

[Frazier] sees the role as a means of helping restore people’s sense of trust and control in the medical system.

“I’ve spent a lot of time developing new medicines and vaccines,” Frazier tells Axios. “I also grew up in the inner city of Philadelphia, so I understand the last mile problem of not having access to care. There’s a lot of dignity involved when you feel you’re in charge, as opposed to having someone dictate it to you….”

Launched in summer 2021, Transcarent has raised just shy of $300 million, including the $200 million in Series C funds it collected in January 2022 led by Kinnevik and Human Capital….

Employer-facing Transcarent gives members round-the-clock access to clinicians via text and offers price comparison tools and quality assessments for medical interventions including surgeries…. The company pays clinicians including surgeons on the same day they provide care….

Well. That sounds promising, indeed.

To be certain, the competitors (Accolade, which in 2020 raised $192.5 million in a second public offering, and HealthJoy) include some deeper pockets, but the opportunity to make health care delivery a more customer focused endeavor in the US… is a vast one. Onward, and Kudos to Mr. Frazier! Have a great weekend, one and all….

नमस्ते

Breakthrough Designation: Moderna + Merck’sKeytruda®, In Melanoma

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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.

नमस्ते

Apple Is 12 Years In — But We’ve Been Covering The Effort For Roughly… Six. Med Devices Are… Hard.

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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….

नमस्ते

A Brief Look — At The Current State Of Potential Marburg Vaccine Candidates, From GAVI… For Guinea Outbreak 2023

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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.

नमस्ते

[UX2: Rejected By The Clerk Of Court!? — Now Avail.] In The “You Can’t Teach Some People… Anything” Dept.

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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.

नमस्ते

Hayward Offers The Best Kind Of Help… The Kind GOP (Or Dem.!) Money Cannot Buy — But In Favor Of Democratic 2024 Candidates.

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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…

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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….

नमस्ते