Developing: Merck IP Backbone Subjected To “Ransom Ware” Hack/Attack

June 27, 2017 - Leave a Response

More soon. Servers across Europe are reporting attacks as well — but it is not yet clear whether these are coordinated attacks.

Merck advises employees to disconnect mobile devices from its network, for the time being. Per Philly.com:

. . . .“We confirm our company’s computer network was compromised today as part of global hack,” the statement said. “Other organizations have also been affected. We are investigating the matter and will provide additional information as we learn more. . . .”

An internal Merck communication warned employees that the company was the target of a ransomware attack on its computer systems and advised them to disconnect their computers from the network. . . .

It is a crazy world indeed. I blame. . . Russia. Heh. And 45.

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Kenilworth’s Anacetrapib Program Gets Some Very Good News — On CETP REVEAL Outcomes

June 27, 2017 - Leave a Response

For almost as long as I’ve been writing this blog (as the prediction in the old graphic, at right would attest), I’ve been covering the twisted path various CETP programs have traversed, from Phase I to. . . today’s new. Pfizer, Lilly, Roche and Merck all have seen varying disappointments — over the last decade — and some moderate successes. [Last Spring’s backgrounder, on Lilly’s travails.]

True enough, today’s real world outcomes data (the gold standard — i.e., a statistically significant number of fewer CV events) is measured only against the performance of a placebo (in patients already on a cholesterol medication) — but the drug’s effect is thus certainly. . . real. From the press release then:

. . . .[Merck announced that] the REVEAL outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen. The safety profile of anacetrapib in the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue. . . .


Merck plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the U.S. FDA and other regulatory agencies. . . .

It is still not entirely certain that Merck will seek FDA approval, given the above mentioned accumulation issue — but it is decidedly good news for Kenilworth — and likely for the whole CETP class of candidates. We still expect no US commercial launch until late in Q1 2018. 

Onward, on a locally gorgeous second Shkreli-hilarity laced jury selection morning — just getting started, now in the US District courthouse’s largest ceremonial courtroom, over in Brooklyn. Smile.

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[U] Supremes To Review Muslim Ban 2.0 Cases; Argument In October 2017 Term. BREAKING! Now With Analysis Of Practical Steps To Take…

June 26, 2017 - Leave a Response

Well, now we know — as predicted, the Supremes have taken the two cases, and consolidated them for review, come October. Opinion granting cert., as a 17 page PDF file here. UPDATED: @ 11:30 AM EDT — After reading the linked 17 pages, of the grant, closely. . . I see five solid votes to strike the Muslim Ban 2.0, certainly in the case of anyone with any specific, articulated connection to a US person or institution. I reiterate: this is no “win” — at all — for 45 (despite what Fox may blare, on the tee-vee). [End updated portion.]

The Supremes will allow 45 to conduct his review for vettings — during the next 90 days; it will also allow the Ban to go into effect, as against any foreign national with no bona fide relationship with a person or entity in the US. Not very surprising, and not necessarily bad — for the opponents of Muslim Ban 2.0.

From Amy Howe, just now:

. . . .We have action on the travel ban. “We grant the petitions for certiorari and grant the stay applications in part. . . .”

“The clerk is directed to set a briefing schedule that will permit the cases to be heard during the first session of October Term 2017. . . .”

“We grant the Government’s applications to stay the injunctions” blocking the implementation of the ban “to the extent the injunctions prevent enforcement of Section 2(c)” — the provision suspending entry from six countries — “with respect to foreign nationals who lack any bona fide relationship with a person or entity in the United States.”

“We leave the injunctions entered by the lower courts in place with respect to respondents and those similarly situated. . . .”

The court emphasizes that the travel ban affects the challengers who want their relatives to come to the US, as well as — for example — the students who want to attend the University of Hawaii. . . .

“. . .Section 6(a) may not be enforced against an individual seeking admission as a refugee who can credibly claim a bona fide relationship with a person or entity in the United States. Nor may §6(b); that is, such a person may not be excluded pursuant to §6(b), even if the 50,000-person cap has been reached or exceeded. . . .”

More soon — but I am still very comfortable that my predictions will prove out. Muslim Ban 2.0 falls, and maybe shortly after October 2017 arguments.

Quickly, then — what a putative immigrant (refugee, or no — from one of the six countries) needs is a letter, from a verifiable source, that a close familial relative (or employer, or an educational institution) is asking for their admission to the US. That’s my take. That should put the putative traveler on safe footing — at least until October 2017, as they enter (assuming no prior bad acts are in the public record as to this same person). But this is not individualized legal advice, as to any person, or fact pattern, of course. Do see an immigration lawyer about your relative’s particular circumstances.

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A Smallish Sunday Head-Scratcher…

June 25, 2017 - Leave a Response

Color me mildly confused. Honestly, I’ll only waste a few sentences on it.

For you see, it is but a small conundrum, in truth. As you might imagine, my confusion (once again!) emanates from the self-contradictory words of a. . . small man. So, it is ultimately a very small matter, from a man with small hands, and clearly — a small mind.

Then-GOP-candidate for President Donald Trump, on July 26, 2016:

. . . .”I will tell you this, Russia: If you’re listening, I hope you’re able to find. . . the emails that are missing,” the Republican nominee said at a news conference in Florida. “I think you will probably be rewarded mightily by our press. . . .”

Yet overnight, Mr. Trump tells the nation, as her President, by tweet, it’s the prior Administration’s fault — that Russia hacked our 2016 election. Did you catch that? He’s admitting Russia-Gate — as a fact — and as an official White House statement, to boot (so says his Press Secretary).

Well. . . I guess, purely as a matter of law, I’ve long considered encouraging a hostile foreign power — to engage in unlawful (treasonous) action. . . to be a very close-cousin — to a crime called. . . collusion. Mr. Trump, it’s time to. . . turn yourself in. You’ve just admitted that the Russian hack occurred, and we all know you very publicly encouraged it, as a candidate — and so, an indictment may lie, for collusion — and perhaps. . . treason.

Confidential to Mr. Mueller — good work, in sweating the suspect-in-chief into an admission (again). But in truth, he is such a easy mark — his (small) thumbs are his own worst enemy.

[Separately, we may hear in the morning that the Supremes have granted cert., in the Muslim Ban cases. Or we may hear the Supremes have affirmed, without an opinion, the lower courts. Either way, 45 loses.]

Closing out cold — on 45.

And 45 is back on the crazy sauce, on Monday morning — by tweet: “. . .The reason that President Obama did NOTHING about Russia after being notified by the CIA of meddling is that he expected Clinton would win. . . .” Whoa — okay — try the decaf, there tiger. . . .

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Clearing Dr. Thomas Koestler’s Name…

June 24, 2017 - Leave a Response

A bit over three quarters of a year ago, we first made mention of the notion, on this blog — and, quite reasonably so at the time — that Dr. Koestler’s name might come up, in Mr. Shkreli’s eight count felony securities fraud trial in the federal District Courts, sitting in Brooklyn. And we were unsure how he would be portrayed.

As of this morning — based on a 41-page order and opinion, just filed there — it is clear that neither the prosecution, nor the defense intend to call Dr. Koestler.

It is also now abundantly clear that Dr. Koestler was simply another one of Mr. Shkreli’s (allegedly) largely-duped victims.

Duped out of payments for his consulting services — in fact, Dr. Koestler has won a $2.6 million arbitration, on that score — but is having trouble forcing Mr. Shkreli to pay that award — as (it is claimed) Mr. Shkreli maintains no bank accounts, of any kind, in the US. Uh-huh.

. . . .At oral argument. . . the parties advised the court that the government will not call investor [XX] as a witness, and that as a result the defendants do not anticipate that they would move to introduce the arbitration decisions. . . .


Should Mr. Shkreli decide to call investor [XX] and offer the arbitration decision into evidence, he shall promptly alert the court and shall also provide the court with a copy of the decision. (Tr. 68:3-5.) The same process should be followed if Mr. Shkreli seeks to introduce evidence of the arbitration with employee [Dr. Thomas Koestler]. . . .

We here unmask him, as we wish to exonerate him — and formally correct the record — lest there be any future confusion. And so, we will tip our hat, belatedly to Dr. Koestler — on this score, at least. We may never know what happened at (and after) legacy Schering-Plough, but we do now know Dr. Koestler was purely a victim — in the Shkreli (alleged) serial fraud saga, on trial starting Monday, in Brooklyn. Do tune in, at the other property — as we will provide nearly real time updates. Now you know, right? And “. . .now there’s gravel, in our voices. . . .” It’s time for a mountain bike ride, along the lake-shore!

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Friday Trivia: “New Rules” Edition — From Another Property…

June 23, 2017 - Leave a Response

[Click the thumbnail masthead image above, to reach/read about it all, on the other property.] I am, by nature, a free markets adherent. So, I make very few rules here. I love the free-wheeling discussions. [And… just for fun, and for a little more “bonus” background — here is the press letter brief, on access to voir dire sidebars — from Tuesday — and Mr. Shkreli’s motion for a hearing, of last night — regarding the government’s right to conduct FBI interviews — of defense witnesses. Both are PDF files.]

And now, the new rule: starting today, and until the verdict is announced, I am politely asking all commenters — and I will try mightily to do so as well, in posts — to refer to the primary defendant solely in honorable terms. We will call him “Mr. Shkreli” henceforth. I will edit future comments to fix it — if it is an oversight.

The notion here is that the evidence alone will convict him.. There is plenty of it, and he creates more day by day — as our commenters have quite ably noted. Most of it is now MSM fodder.

So, on the eve of trial — I’ve updated the masthead, and made the above request — that we accord him at least a modicum of professional respect. Our tiny blawg will not change any outcome — and the MSM is likely to cover all of this far more graphically than we may — but let’s play fair, just the same.

Let the evidence do the talking, from here on.

Okay — let ‘er rip! Bring on the piping hot french fries, ketchup, icy real cane sugar Coke and if you’d like… popcorn.

I’d expect some final (weekend) orders out of the able Judge’s chambers, in Brooklyn — and I will post them, in near real time, from PACER — then jury selection begins in earnest, on Monday morning. Have a restful, languid, free spirited weekend, one and all. I don’t expect Mr. Shkreli will sleep (much) — for at least the next six weeks.

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Merck And Premier Expand Vaccine- And Chronic-Patient Care/Affordability Alliance

June 22, 2017 - Leave a Response

Not Earth-shattering, by any means — but (I think) likely a response to the lower rungs of the 45 Administration’s (Scott Gottlieb and Tom Price, primarily) idealistic talking points — about exploring ways to bring total costs in line with tangible patient benefits achieved.

[And as is true with so many US Health Care ideas en vogue today in 2017 — it is, in many respects, a “retread” — of Mr. Obama’s suggestions from early 2011.]

Here it is, from Kenilworth’s press release — and a bit:

. . . .In 2016, Merck and Premier agreed to collaborate to develop and assess solutions that promote wellness and better care for specific groups of at-risk patients across the continuum. The organizations have now launched two projects under this collaboration model. One is a preventive care model that seeks to improve adolescent and adult vaccination rates. The other is a chronic disease model that includes a new focus on type 2 diabetes patients at risk of hypoglycemia, as well as osteoporosis identification and treatment (as announced in 2016).

“Our expanded collaboration allows us to more effectively support health systems and clinicians that are evolving from volume to value-based models, but lack adequate prevention and wellness solutions,” said Dr. Mimi Huizinga, M.D., chief health information officer at Premier. “We’ve been working with Merck to design data-driven interventions for some of the top population health challenges facing our country, and we’re eager to start testing them in the real-world.”

The vaccination and chronic care models combine the improvement expertise and technical capabilities of Premier with Merck’s education and therapeutic area expertise. The companies are now developing plans with interested health systems to test these models on the frontline, in real-world settings. . . .

Good ideas. . . are simply. . . good ideas, henceforth. Now you know, with a smile going out to one and all of good will — which seems a smaller and smaller subset. . . indeed. Onward.

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Y A W N. Senate Version Likely Will Not Clear US House…

June 22, 2017 - Leave a Response

To much faux-hullabaloo, the Senate GOP leadership is releasing its super secret plan for health care delivery, at this very moment. YAWN.

It is, in the main, ObamaCare 2.0 — with decreasing subsidies after seven years — conveniently just beyond the time when the more moderate Senators will need to seek re-election. It is actually not too horrific — as in many ways it is ObamaCare 2.0, or Lite — if one prefers. It keeps protections against pre-existing conditions exclusions. [One of my literally dozens of backgrounders, here.] Of course anything in it is likely to be amended in the next five to seven years — even if by some miracle both chambers agree on. . . anything.

And that is why it is DOA in the US House. Those GOP critters face re-election in 2018. And all of them told lies about repealing ObamaCare. This Senate package does no such thing. So I’ll adhere to my view that 45 will receive nothing to sign, before 2018 mid-terms — and maybe. . . never. From the Wa Po’s Health 202 blog, then — a bit:

. . . .The Senate bill. . . subsidies closely mirror Obamacare subsidies, which are currently available to Americans earning between 100 percent and 400 percent of the federal poverty level. Starting in 2020, under the Senate bill, this assistance would be capped for those earning up to 350 percent — but anyone below that line could get the subsidies if they’re not eligible for Medicaid. As under the ACA, the subsidies would be pegged to a benchmark insurance plan each year, ensuring that the assistance grows enough over time to keep coverage affordable for customers.

McConnell is also offering moderates an approach to Medicaid he hopes will be more politically palatable to them. It’s true the draft proposes even deeper cuts to Medicaid than the House version by tying federal spending to a slower growth index. But that wouldn’t kick in for another seven years, well past moderate senators’ next reelection battles. And it doesn’t fully end the ACA’s Medicaid expansion until five years from now, gradually easing down the extra federal payments over three years starting in 2021. . . .

Y A W N. So, the ACA of 2010 remains the law of the land, just as I foretold. No binding changes in existing law — in any case — until after 2018. That’s Condor’s (my) prognostication. What a pack of incompetents. How droll. I think I’ll go take a sunshine-dappled June summer’s morning. . . stroll.

Hey. . . that rhymes. Smile. . . .

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We May Now Probably Call The 2017 Congolese Ebola Outbreak… Over.

June 20, 2017 - Leave a Response

The latest WHO Situation Report contains exceedingly good news. We — the collective “we” — may breathe a sigh of relief, now.

Here late on Tuesday evening, I will go out on a limb and say that — with a 97 per cent confi- dence/probability factor — from these WHO statistical regression models, there will be no new cases in the Congo, in the next 30 days. That, in turn, would mean the current Ebola outbreak has been. . . arrested. From that June 20 WHO report, then:

. . . .Cumulatively, since the start of the outbreak, there have been five confirmed and three probable cases.

Additionally there have been 99 suspected cases reported that following laboratory analysis tested negative for EVD and therefore were deemed not to be cases. The last confirmed case was isolated on 17 May 2017 and tested negative for EVD by PCR for the second time on 21 May 2017. Of the confirmed and probable cases, four survived and four died, resulting in a case fatality rate of 50%. The confirmed and probable cases were reported from Nambwa (four confirmed and two probable), Ngayi (one probable) and Mabongo (one confirmed).

Data modelling suggests that the risk of further cases is currently low but not negligible, and decreases with each day without new confirmed/probable cases. As of the reporting date, 97% of simulated scenarios predict no further cases in the next 30 days. . . .

Excellent. Now, I will be on trial (pro bono), essentially all day tomorrow — so, phone off. . . in federal court. If 45 does something stupendously inane — it will have to wait, until evening. Be good to one another.

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Part Two, of How Mr. Bannon Painted Mr. Trump Into A Corner, On Muslim Ban 2.0…

June 20, 2017 - Leave a Response

The able lawyers for the State of Hawaii just filed the first 12 pages of their answers to the Administration’s papers — at the Supremes, mere moments ago. [Hawaii’s additional moving papers, another whopping 8 MBs worth of PDF goodness here.]

Below in blue are the high points — but Mr. Bannon continues to kill Mr. Trump’s efforts, here. Actually, that may be a tad unfair, since it is not so much the inept, and ultimately transparently dishonest drafting of Mr. Bannon — as it is the odious religious animus of Mr. Trump — openly tweeted — that has doomed him, in the Supreme Court.

. . . .The government’s insistence on implementing the ban even in these circumstances [Ed. Note: That would be the hastily slapped together Presidential memo of June 14, 2017 — decoupling the effective dates for any review from the ban’s effective dates] is inconsistent with the purposes stated in the Order and in the government’s papers — but is consistent with the President’s clearly and repeatedly stated goal of preventing Muslims from entering the United States. . . .

[T]he President’s June 14 memorandum decouples the bans from the vetting upgrade they allegedly facilitate. . . . Because there is no remaining facially legitimate secular rationale for the Order, the Government can no longer dispute what has always been obvious: the travel and refugee bans represent an unconstitutional effort by the President to fulfill his campaign promise to enact a Muslim ban. . . .

[The courts below have not disagreed (on the outcome, or the substance, really) at all — ALL have held that Muslim Ban 2.0 cannot pass muster, each just on slightly differing analytical grounds. . . . so there is no real split among the circuits, that needs resolving, here. . .] [A]s the lower courts have repeatedly observed, the case is truly unique. App. 61a-62a; 252a. . . .

No case in our history involves an even remotely similar factual record, and the court of appeals’ decision applying this Court’s precedent to this unique set of facts does not restrict this or any future President’s legitimate exercise of his or her extensive national security powers in any way. See Opp. Cert. 15, 20-29. There is no reason for this Court to grant certiorari. . . .

[Footnote:]. . .Should the Court grant the petitions for certiorari in this case and the Hawaii case, the respondents concur with the government that the cases should be heard in tandem, rather than consolidated. . . .

Now, in truth — I still think the Supremes aim to take this case — and rule, issuing some truly towering Hamiltonian language. But there is nearly no chance the Ban will survive. Condor predicts: Nine-to-Nuthin’ — upholding the various TROs and preliminary injunctions entered below. See ‘ya, 45.

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