For The “Fire, Next Time”: Large Ebola Vaccine Study: Merck’s Vaccine 100 Per Cent Effective — Final, In The Lancet

December 23, 2016 - Leave a Response

mrk-alt-newlink-anti-ebola-12-2016When — not if — there’s a “fire, next time” (ref. James Baldwin). . . Merck (and its NewLink partners, along GAVI and with the original research by the Canadian Health Agency). . . will be ready. Its vaccine is now definitively 100 per cent effective against Ebola — according to large, final “ring method” vaccine study results.

[Backgrounder, from exactly one year ago — last night, here.] This is decidedly great news, for Africa primarily — but for all of us, as a broader human community of concern, as well.

From the very encouraging WHO press release, this morning then — and a bit:

. . . .An experimental Ebola vaccine was highly protective against the deadly virus in a major trial in Guinea, according to results published today in The Lancet. The vaccine is the first to prevent infection from one of the most lethal known pathogens, and the findings add weight to early trial results published last year.

The vaccine, called rVSV-ZEBOV, was studied in a trial involving 11,841 people in Guinea during 2015. Among the 5,837 people who received the vaccine, no Ebola cases were recorded 10 days or more after vaccination. In comparison, there were 23 cases 10 days or more after vaccination among those who did not receive the vaccine. . . .

And so we should see a quick arrest of any future viral outbreak — unless (of course) the virus is out there, right now mutating — in the wild, in some way that makes it impervious to this particular dead viral material, in a grafted simian encapsulated container. So sorry to skew ominous, near the Lord’s birth but. . .

My opening was in fact taken from a prophecy — in a song of a slave:

God gave Noah the rainbow sign,
No more water, the fire next time
. . . .”

And in it, Mr. Baldwin (perhaps foreshadowing the rise of the 45th President) pleads: “If we — and I mean the relatively conscious whites and the relatively conscious blacks, who must, like lovers, insist on, or create, the consciousness of others — do not falter in our duty now, we may be able, handful that we are, to end the racial nightmare, and achieve our country, and change the history of the world. . . .”

Otherwise, the next time, fire. . . this is my abiding fear. But it is also my abiding hope — that we will move beyond the need for it — catalyzed (as irony would have it) by the hate Mr. Trump encourages — to be met with “we, as a nation, are better than that — now. . .” For, as Baldwin wrote: “I think we must believe it is possible. . .”

Namaste — and amen.

नमस्ते

Just A Lil’ Housekeeping, Then: Post Trial Motion Schedules — On That $2.54 Billion Jury Verdict…

December 22, 2016 - Leave a Response

mrk-alt-gil-verdict-hep-c-12-15-16 Most of this will play out in the New Year, but I thought the readership might like to see “what’s next” — besides an appeal obviously — in the Merck/Idenix $2.54 billion nominal patent award. In sum, there is quite a long road yet ahead — no matter which side ultimately prevails.

Here is that four page PDF of a status report — on post trial motions, and scheduling.

Now you know. Falling now, as silent as the snows, then. . . . smile.

नमस्ते

The Two “Mercks” Are Still Battling Over German Vs. New Jersey Law… And, Merry Christmas!

December 22, 2016 - Leave a Response

As I close up my shop for the holiday, and head out for airport pick-up runs — I’ll wish the readership a blessed and peaceful Christmas. As many here already well-know, I no longer consider myself bound by all those covenants, but I respect those who still say they are. . . .

So — to all true Christians — I wish you a Merry Christmas. I assume you would wish me the same. [I mean all of you who believe in Christ’s “social gospel“, here — and yes — I apologize — that is an oblique reference to certain followers of our 45th President.]

Now. in a “cheerier” fashion, and to keep you all well-entertained, I’ll leave you with some fire-side reading. For the last two months, the two Merck companies have been battling in the federal courts located in New Jersey, over what country’s law will govern their naming rights disputes. [Background here.] In both the UK and French versions of these battles, trial level courts have held that German law should apply.

I still think — given that it is a US Lanham Act suit, which is derivative of the overall contract action — the substantive federal US law (in turn applying New Jersey state contract law rules) will be applied, by the able judge. Even so, I am not sure it matters all that much as to which law governs the fact that the contract exists and is in force. I now supply links to US Merck’s opening brief — and to German Merck’s reply — to US Merck’s rejoinder. . . AND to German Merck’s sur-reply(!). That’s about 90 pages, in all. Enjoy your bed-time reading, folks! I’m out, now. . . .

It is (I think) profoundly sentimental here — that these silent, snowed in, moments make things luminously. . . clear (upon inspection of these individual snowflakes, close at hand). And as I go — I bid all of good will, peace on Earth. And thus. . . Namaste.

नमस्ते

The Truth: ObamaCare Exchanges NOT In Any Danger Of “Collapsing.” Period.

December 21, 2016 - Leave a Response

life-obamacare-sign-ups-for-2017 It is. . . immensely frustrating that so many otherwise educated people bought into the demonstrably-false assertion that the exchanges would “collapse” due to a (coming, imagined — not real) lack of sign-up volume, this year. In fact, Mr. Trump amplified that falsehood, along with a pile of other ones, to win at least some votes — based on a fear of the next-steps — under ObamaCare.

But, as ever — the actual data has put the lie to these assertions. A few minutes ago, the MSM Washington Post ran the following story. In fact, it notes, 2017 (incoming) signups are on a pace to exceed 2016’s — and the exchanges will thus remain solvent — and stable.

That’s correct — the sky is simply not falling. Here’s a bit — but do go read it all:

. . . .More Americans have signed up to have health plans through the Affordable Care Act as of Jan. 1 than in previous years, despite spiking insurance prices and a pledge by President-elect Donald Trump to dismantle the law.

Health and Human Services Secretary Sylvia Mathews Burwell announced on Wednesday that 6.4 million people had chosen Affordable Care Act health plans by the deadline this week for coverage starting New Year’s Day — an increase of 400,000 from a year ago, though fewer first-time customers enrolled.

Yet, as Burwell said the figures signify that “doomsday predictions about the marketplace are not bearing out,” Obama administration officials and health policy researchers who support the law have been taking precautions before Trump takes office.

Since shortly after last month’s election, think tank and university researchers have been downloading Affordable Care Act data, reports and regulatory guidance housed online at HHS — in case the new administration removes them as part of its efforts to wipe out the law. . . .

So it goes. It is infinitely sad, that (even if it turns out not to transpire) many responsible researchers are archiving back-ups of free public federal health care data sets — just in case Mr. Trump decides to try to “disappear” the truth.

Moreover, it is sublimely ironic — but likely true — that Mr. Trump’s election has (in the near term) spiked sign-ups, as the poor seek a would-be “last refuge” — before a supposed coming storm. We shall see — but we must all simply call these Trumpian lies — just that. Lies. We must govern on data — not tin-foil hatted conspiracy theories. Now you know. Onward — into the blowing snows.

नमस्ते

Mid-December Federal Propecia® MDL Updates: Four Bellwethers Now In Place — General Trial Schedules Hold Firm

December 21, 2016 - Leave a Response

life-mrk-propecia-compare-12-21-2016 Largely as expected, the very capable Judge Brian Cogan in Brooklyn’s US federal District Court has now selected the replacement “bellwether” case — for the first tranche of four such “test” cases. [A little recent local color of mine, on the state versions, resides under that link.]

In so doing, he kept the federal MDL on its existing overall time-line track, at right (click image to enlarge, and compare) — and thus preserved the probability that my much earlier guess (circa February of 2016) would turn out to be accurate: that the federal trials would be underway ahead of the NJ state MCL trials, on the same issues. I continue to believe that.

So in the mid-to-late Fall of 2017, we will see the first federal bellwether trial begin. I would guess mid Q1 2018 for the first, in New Jersey state court. Here’s a bit from the order (a shortish PDF file), of two days ago, then:

. . . .By December 30, 2016, the parties are ordered to submit a joint letter listing the discovery that is outstanding for Finn and advising the Court of the amount of time necessary to complete that remaining discovery. Further, the parties will advise the Court if they believe any modifications to the schedule outlined in PPO 10 are necessary given the selection of Finn and the time they believe is needed to get Finn on the same track as the other three bellwethers. If the parties believe any modifications are necessary, the parties should propose a revised schedule to the Court by December 30, 2016.

Finally, if the parties have any reason to believe that any of the other three bellwethers may be subject to dismissal in the near future, the parties should advise the Court immediately so that any other replacement(s) can proceed on the same track as Finn.

SO ORDERED. . . .

Now you know. So, with the coming holidays, and soon to be newly-blowing light sugary snows, blog posts may be scarce through Tuesday of next week, here. Do enjoy a cracklin’ fire, and some peaceful, festive (and Kudos-bearing) family time, one and all. . . . I know I will. Smile. . . . pax tecum.

नमस्ते

On The Unwasted Grace Of A Shepherd Moon… Discovered Fifty Years Ago, This Night…

December 18, 2016 - Leave a Response

life-epi-black-walker-12-20-16First, a little space science — these two tiny moons, orbiting Saturn, pass very close to one another every so often.

Initially, in the mid 1960s, other respected astronomers said that it wasn’t possible that these two moon-lettes had achieved a stable orbital equilibrium (i.e., that they could occupy the same orbital space and plane, without an eventual cataclysmic collision occurring). But the usually wise astronomers were wrong. They could; and they do.

The pair orbit in what are best described as horseshoe shapes (see lower image); in fact, the two end up trading orbits each time they pass near one another. That is generally what a shepherd moon does: it corrects the orbit of the shepherded moon. In this case, though (unique in all our Solar System, we believe), each. . . perfects the other. That is. . . simply amazing — and poetic.

So — let us listen in a bit then, on a resonant poem — for Epimetheus — the sibling of Prometheus (and, in this case, the star-swept occasional partner — to Janus, the other Saturninan moon in this orbital space). From this fine longer poem, called “Waterlilies Soon And A Pleiku Of Dragonflies” a bit — with edits (original author: Patrick White), then:

mrk-alt-life-masthead-12-19-16

. . . .Waterlilies soon and a Pleiku of dragonflies.

Shipwrecked fleets of naked limbs. . .
buried at sea wrapped

in a starmap of the sky. . . .

I will forget I am aging. I will be a medicine bag

of healing metaphors and powerful occult charms. . . I will
lie down upon the earth in the unassuming grass

after I’ve finished painting, fascinated by the. . .
stranger I’ve become to myself, listening deeply

to the picture music of the life of the mind like a kid

with forty-eight crayons and the whole of the sky to draw on

as I wait for the stars to make themselves apparent
in the sweet, sweet darkness that envelopes me. . .

in the [copper-colored] flames and [deep-]violet shadows of another

[exquisite] martyr — to the cause of keeping their fires alive within me,

a dragonfly in a chrysalis, a hermit thrush in ecstasy,

life-shepherded-moonlettes-2016a sulphur butterfly with antennae like burnt match sticks
looking for a light from the lanterns of the nightwatch
reigniting the passions of old poems like fireflies

inspiring the ashes in the urns of the stars to enlighten their afterlife. . .

fracturing koans like diamond insights into

a labyrinthine gallery of mirrors that see me

with the same eyes by which I see signs

of the disastrous happiness of life in them. . . .

And with that, I will quite easily drift off to sleep, shepherded once more, by my own moon-lette — somewhere, to the South, out there. . . smile. G’night.

नमस्ते

Messrs. Shkreli And Greebel Lost In Brooklyn, Friday — On Their “Brady Materials” Motion(s)…

December 18, 2016 - Leave a Response

shkreli-alt-brady-loss-12-17-2016Here on Sunday morning, the PACER felony docket sheet in Brooklyn has been updated to reflect all the filings and orders from Friday, the 16th — and the related status conferences, before the able Judge Matsumoto. It was a decidedly bad day for the defense. [Much more, here.]

To sum up, the government won on all essentially fronts. Mr. Greebel, in particular, came away a loser. [Here is that 19 page PDF of the memorandum opinion, as signed by Judge Matsumoto.] There is no surprise here, as Messrs. Shkreli and Greebel have repeatedly, and foolishly, over-played their hand(s). The government has them — nearly dead to rights — in written documents, many of which Judge Weinstein has ruled are “crime fraud” doctrine excepted. That is, they document a criminal fraud conspiracy — between Messrs. Greebel and Shkreli.

So, the effort to “screen a preview” of the entire government “feature film” that the jury will watch (against them), more than six months ahead of the June 2017 trial date (the “premiere,” in the court’s apt turn of phrase), has been ruled out of bounds.

More broadly, it seems all those conflicting production of documents arguments and motions — both privileged and not so — are being steadily reduced to simple disclosures to Mr. Brafman’s firm (on an “eyes only” basis). [It seems Mr. Biestek will be allowed to at least review documents — for personal privilege, as well.]

shkreli-one-year-on-201In addition, the court (by separate order) has made clear that none of this will delay the June 2017 trial date.

Finally, once again, the court has noted for the record, Mr. Shkreli’s own prior and public conduct — in attempting to threaten (or in at least one instance, actually threatening) witnesses, in the civil securities fraud matters — as a firm reason not to accord too much leeway — to his requests for a preview of the government’s case (and thus its witnesses).

These two men are actually in some very dire criminal legal circumstances, in my experienced opinion. And Mr. Shkreli (in particular) continues to treat it all as some form of online game. He is bound to lose — and forfeit likely ten years or more of his liberty, for his hubris. [Again, in my experience.]

So it goes. [And, I do hold at least some hope that tomorrow yields a truly-Hamiltonian solution — at the Electoral College convention.] Now I’m off to shovel again, under the frigid but clear morning sky — before the falling temperatures make it all a block of solid ice. . . headed to negative teens later this evening, into the luminous dawn, on Monday. . . smiling just the same. Everyone’s home in just five more days. . . .

नमस्ते

Martin Shkreli Update: It was exactly one year ago, this morning, he was perp-walked… “He. Just. Can’t. Help. Himself.”

December 17, 2016 - Leave a Response

shkreli-12-16-16-tweetTake a look (at the posts, on another property of mine). If you’ve ever played organized competitive sports, you understand the idea (the coach’s idea, really) of using what the other guy/other team is saying — as strong motivation.

Trash talking. Talkin’ junk. That’s what this is.

Me? I’d personally bet that the able AUSAs in Brooklyn have a small (but now-crowded) cork-board — in one of their offices/ conference rooms — and it has paper copies of tweets like this one plastered all over it.

There is no shortage of them, in truth — stretching back over a year, today. But Mr. Brafman had warned Mr. Shkreli, in front of the press, last summer — to knock this nonsense off. But that one was tweeted last night. I suspect the one-year anniversary of the perp-walk has him addled.

shkreli-one-year-on-201Stupid. Now it ALL serves as a “motivation folder” — for the AUSAs.

And, perhaps more importantly, when it comes time for his eventual sentencing hearings, tweets like these will be offered by the AUSAs, to the judge — as evidence that Mr. Shkreli regards the federal criminal statutes as some sort of video game. Just a minor maze to beat — to run through — in the allotted time.

Such outbursts are likely to lengthen his eventual sentence. Not very smart.

Now you know.

As I Said Last Night, Gilead Is Only “Marginally” Impacted By The Merck Delaware Patent Verdict…

December 16, 2016 - Leave a Response

The NYSE here demonstrates the wisdom of the crowd, this morning. [Or the efficient capital markets theorem, if you prefer.]

It makes sense that Merck is up a bit — as this was clearly a bit of good news — for Kenilworth. Even so, there is much yet ahead in the global patent battles related to these Hep C cures.

And that explains why Gilead — while opening a little lower (just over one per cent, compared to last night’s close) — has generally moved north from there, on strong volume, all morning.

We should not forget that Merck’s last win — on these same matters — was ultimately wiped out, entirely, in bench proceedings, after the jury’s verdict — last summer, in California’s Northern District.

Object Lesson: US patent law is quite a bit more complicated that just the jury’s role of finding facts. [And perhaps even more directly (though straight financial analysis is usually beyond the blog’s scope), Gilead has sold $25 billion worth of these cures — with no let up in sight. If it reduces its gross margin, overall, going forward, by the max of 10 per cent (Merck’s putative royalty). . . Gilead is still well-ahead. As I say, it will be fine.]

As ever, forward — into Sweet Will’s “undiscovered country” — with much more to come. Breathing easier now — under much warmer, if gray, skies. The snow arrives in earnest again, this evening. Smile. Onward — as ever. [Disclosure: I am not long or short any name I write about here.]

नमस्ते

BREAKING: Merck Nominally “Wins” A $2.54 Billion Hep C Patent Verdict — From Gilead; Reduction Likely, Says Condor…

December 15, 2016 - Leave a Response

mrk-gil-verdict-hep-c-12-15-16But first, come — let us reason a moment, here together, though: this is simply the end of Act I, in a Three Act play.

Yet to come in Delaware is the bench portion of the trial — as to Gilead’s OTHER purely “legal” theories (i.e., not factual questions — not questions for the jury to decide, at all) on various defenses of patent invalidity. There are at least three of those that come directly to mind, here — and the able judge will need to rule separately — on those. This is a win for Merck — but just like the $200 million win Merck received (only to later lose it all, and more) this past summer, in California’s Northern District Court (San Jose) — there is still a lot of dust yet to settle, here. Here is the only unsealed verdict form (a four page PDF file, that). In fact, there is also a SEALED verdict form — one which we cannot see. No one can, in fact. It may well cut the other way — in favor of Gilead. But we shall see.

[Of course, should it stand on appeal, and not be subject to remittitur, it would be the largest patent infringement verdict in the history of the US courts — just as we’ve long suggested.] Here’s a bit — from what we can see:

. . . .On Sales of _$25.4_ Billion. . . (through August 2016). . . At a _10_ Per Cent Running Royalty Rate. . . . [equates to] $2.54 Billion. . . .

At the outset, I will remark that a 10 per cent running royalty is at the very high, upper limits of what anyone versed in this area might ever expect — given the Merck patent position, relative to Gilead’s later (alleged) innovations. I suspect that alone will be substantial grounds upon which to reduce the jury’s verdict.

There will also certainly be appeals — on all sides. And who knows what the sealed portion of theose verdict forms hold? None of us. That’s who — save only the judge and the lawyers, in the courtroom. So — do not oversell Gilead in the morning, and do not overly bid Merck up, pre-NYSE open tomorrow. Much yet to come.

We will watch and wait — through this frigid, clear and Super-Moon lit night, now. . . . smile.

नमस्ते