[For At Least Ten Days,] I May Just Close This Blog Off — Right Here. नमस्ते Travel Light.

May 20, 2018 - Leave a Response

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[U] We Await Word, Now — On Whether WHO Has Declared 2018 DRC Ebola Outbreak “Of International Concern”…

May 18, 2018 - Leave a Response

The WHO body responsible for making the determination — as to whether the outbreak should be upgraded from a “regional” concern, to an international one — based on the two cases inside the riverport city of Mbandaka. . . is meeting as I type this.

We should know in a few hours. An upgrade would release additional NGO and EU funding — but the US is largely on the sidelines on this one (either way), due to Mr. Trump’s early 2018 cuts at CDC (for international pandemic responses) and last week’s singularly ill-timed cuts to Ebola aid, generally (eliminated $250 million).

Even so — we will remain hopeful — that the vaccine is now quickly, and widely, deployed — in the riverport city of over a million souls. Onward, on a clear cool Friday. . . let’s be better to one another. . . than our president is. Much better.

UPDATED: at days end, the WHO officials have decided (for now) they will not escalate the 2018 Congo outbreak’s designation, as it hasn’t crossed a geopolitical border as yet.

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Nuvaring® MDL Close-Out Mechanics — Status Call In Federal Court In Missouri Underway Now….

May 17, 2018 - Leave a Response

Slowly. . . but surely, this $100 million settlement is winding its way down.

Here is the complete agenda as a three page PDF, and a bit:

. . . .1. Next group of cases for remand.

2. Anticipated motions to dismiss by Defendants for certain pending cases in which Plaintiffs have not provided discovery.

3. Plaintiffs’ request for updated Periodic Adverse Drug Experience Reports submitted to the FDA. . . .

Of these, Item 3 is potentially the most interesting, depending on what might be disclosed, in those subsequent adverse event reports, to date in 2018. Now you know.

Off to the food trucks — under sunny skies: lobster rolls and tomato bisque with cilantro for lunch now! [All with beautiful, twisting copper-torso visions — of exactly four years ago, this week. . . and a “Divergent” Wednesday matinee — complete with changing room antics — pulsing through my mind, and soul. . . smile.]

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[U] Significantly Disconcerting Ebola News, Out Of Mbandaka, DRC: One New Viral Case, Inside A City Of 1.2 Million People

May 17, 2018 - Leave a Response

UPDATED @ 2 PM EDT — in one rather hopeful sign here over lunch, the NYT is reporting this afternoon that the two cases inside the city are a pair of brothers who earlier attened a funeral in Bikoro — thus making it likely that this is all one transmission chain, out of Bikoro, and not a separate (previously undetected line) originating inside the city of 1.2 million — a city that is a river-port and transportation hub. That is good news. Still, this all could rapidly become an international pandemic, if every contact of every contact is not ring-vaccinated essentially immediately. [End, updated portion.]

This is not intended to unduly alarm people, but thus far — in the main — ebola outbreaks have been confined to remote rural areas, and small villages.

This May 2018 DRC outbreak may be regarded, as we look back some years from now, as a “game changer” — in the words of Dr. Peter Salama, a WHO official presently leading the emergency response efforts.

You see, there is now a confirmed case of Ebola — the highly contagious, ruthlessly lethal virus (more than half of those who contract it will die of it) — inside a Congolese riverport city of over 1.2 million people. From the WHO update, of earlier this morning, local time:

. . . .One new case of Ebola virus disease (EVD) has been confirmed in Wangata, one of the three health zones of Mbandaka, a city of nearly 1.2 million people in Equateur Province in northwestern Democratic Republic of the Congo. . . .

“This is a concerning development, but we now have better tools than ever before to combat Ebola,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “WHO and our partners are taking decisive action to stop further spread of the virus. . . .”

It is true that WHO (thanks in no small part to the efforts of Merck, NewLink and the Public Health Agency of Canada governmental research labs) is in a much better state of preparedness.

Specifically, we do have Merck’s rVSVΔG-ZEBOV-GP vaccine stock available, at the ready for overnight flight shipping — but this could get seriously out of hand — and quite rapidly so. Keep a good thought — that Trump’s karmic deficits don’t cause any more loss of life, or additional suffering inside Mbandaka, Wangata, DRC. Onward, now. . . on, to the morning trains.

नमस्ते

Status Update, On Propecia®/ Proscar® Settlement Next Week; Final Dismissal Lists By August 15, 2018

May 16, 2018 - One Response

Our latest copper colored, fleet-of-foot visitor has twisted by — orbit bent, only slightly — and completely harmlessly so, overnight. So. . . it is back to regular fare, here.

By next Tuesday, we should know how much progress has been made on the finasteride MDL/ MCL settlement mechanics, by way of a jointly-filed letter update, from the two sides’ legal teams. [My recent backgrounder on the settlement may be found, here.]

The below is the full text of the able judge’s overnight order:

. . . .The parties are to provide a joint update by 5/22/2018 describing the progress of the Settlement Program and confirming that they will advise the Court by 8/15/2018 which claims can be dismissed.

Ordered by Judge Brian M. Cogan on 5/15/2018. . . .

Now you know. And. . . onward, on an otherwise fine morning — but one that sees Trump for the unsophisticated, primitively-naive rube (ignorant of history) he is — now being easily manipulated for the world to watch, by a North Korean crackpot dictator (and to a lesser extent, by his son-in-law, in carving up the Kushner family spoils, from the move to Jerusalem). Once again, like the ZTE-China-Indonesia Trump Resort deal — clearly, corrupt emoluments are. . . in process. Sad!

More hopefully, though — I might add that after listening to the full audio feed of the Ninth Circuit’s DACA II oral arguments late last night, I am increasingly comfortable that 45’s attempt to pull the rug out from under young people who relied to their detriment on it. . . will fail. Onward, then — as a new day opens, before us — full of possibilities.

नमस्ते

[U] Some Lighter Fare: Interstellar Space Science — And… Another “Sorta’ Close Shave”, This Evening?

May 15, 2018 - Leave a Response

At around 6 PM EDT this evening, a football field sized rock will whiz by, at 28,000 miles an hour — passing fairly close, inside the orbital distance between the Earth and her moon. [There is just too much hatred — in the hard news stories, of this day. . . . so we will shift to celestial poetry, and ancient mountain canyons echoing the same, in their running waters.]

It is absolutely no existential threat, and may truthfully only be seen with a mid-range (or better) telescope, and then, only if the skies are clear tonight — and one knows exactly where in the sky to. . . look. Even so, I am already hearing the echoes of silvery words, writ in water. . . . of shepherded moons:

. . . .Like many. . . in [the high Rockies,] where the summer days are almost Arctic in length, I often do not start [river rafting] until the cool of the evening.

Then in the Arctic half-light of the canyon, all existence fades to a being with my soul and memories and the sounds of the [headwaters of the Arkansas] River and a four-count [oarsmen’s] rhythm and the hope that a trout will rise [not too far ahead of the bow, shimmering in the rose light].

Eventually, all things merge into one, and a river runs through it. The river was cut by the world’s great flood and runs over rocks from the basement of time. On some of those rocks are timeless raindrops. Under the rocks are the words, and some of the words are [mine, to you]. . . .

—Norman Maclean, A River Runs Through It (1976)

This rock, called Asteroid 2010 WC9 — like me — poses no even remotely plausible existential threat to anyone’s family, or life, on Earth. Now you know. And, some of those words are mine, to you. . . . working from home this fine Tuesday. Smile — baby duty early, today. [To burn at a distance, or to freeze. . . nearby?]

नमस्ते

[U X2] Congo 2018 Ebola Outbreak: Bikoro Update — 22 Probable And Confirmed Cases — May 14, 2018

May 14, 2018 - Leave a Response

UPDATED @ 1:00 PM EDT — There are suddenly 19 dead, and two of them are health care workers (greatly increasing the odds that the virus has now been transmitted regionally). This is how explosively dangerous the virus in the wild can be. On the plus side, here at lunch however, WHO has obtained clearance to vaccinate, from local health authorities. And starting now the initial up to 4,000 doses are being administered, in Bikoro region.

Even so, the WHO team is tracking at least 400 contacts of contacts. We should expect that as many as a third of those may become sero-positive, without a vaccine. This all via a Wa Po update. Sure is a good thing that just last week, 45 cut the remaining $250 million of US funding for Ebola fighting efforts in Africa, calling a working (life-saving!) vaccine candidate. . . “wasteful.” I am beyond disgusted by him (this is more of his “shithole-self“, emerging). [End, updated portion.]

As I had intoned earlier, the news will be worse for a while, before it starts to get better.

First, though, on the more hopeful side: Merck’s “cold chain” delivery logistics seem to have worked: large numbers of Ebola vaccine vials, still at sub-zero (and thus likely plenty-potent), are on the ground now in and around Bikoro. Next, WHO health workers, well-trained, and battle-tested, from last time around (in Guinea and the Congo), are on-site, and collecting contacts-of-contacts data (for vaccination deliveries). Finally (on the plus side of the ledger), a smallish airstrip is being cut out of the verdant but mountainous, and twistedly tangled forest — around Bikoro — to speed future aid and medical personnel arrivals.

And now, the as-expected bad news: case counts are increasing (from 11 as of Friday, last), thus (per WHO-tweets):

. . . .Latest case count:

2 confirmed cases

20 probable

17 suspected. . . .

That’s likely 39, from what was 11 only four days ago. Time to start vaccinating all contacts of contacts, in and around Bikoro. To the trains — in a cool, foggy rain, then. . . . be of good cheer, just the same.

नमस्ते

[U] After Trump Demanded A US Bailout — For ZTE — A “MASSIVE” China-Based Phone Maker, I Immediately Flashed On This…

May 13, 2018 - Leave a Response

. . .of course, it’s lame, as acting performances (and free-style rap performances) go, but there is much truth. . . in these words — even 20 years later.

And it is true of BOTH Democrats and Republicans — the same ills that beset us in the latter days of the Reagan-Bush 41 era have returned — in a more virulent, more cynical form, under Donald Trump.

UPDATED: A mere 72 hours later, we know what Trump Inc. got, in return for the above ZTE announcement: $500 million from China, for a Trump resort in Indonesia. Deplorable.

The saddest part of all of this is that the Trump apologists in DC, and in red states, are going to make up excuses — rather than ask directly: “Who paid him what sort of a corrupt emolument, for his sudden preference for a Chinese billionaires’ company (one under US trade sanctions) — over US workers who’ve lost their jobs (at least under his professed view, as a result of unfair competition from these same Chinese manufacturers). . . .?”

To be clear, I do not ascribe to that bogus theory of voo-doo economics. But if 45 is going to say it is true, and claim he wants to put “America First” (again), he ought to explain how a Commerce Department bailout of ZTE is consistent with any of. . . his previous lies.

Yes — the video is low quality screen cap, and yes, Warren Beaty was mis-cast. But he is channeling Don Cheadle’s earlier monologue in most of his rap.

The words of “America First” were always lies — glaringly obvious ones, in fact — but still I bet the GOP will cover for Trump here, on Monday morning. Obscenity?!

Ob-scen-i-ty?! Obscenity!

नमस्ते

The Hep C “Unclean Hands” Patent Fees Determination May Come From The Federal Circuit (Appellate) Court, Not The Trial Court…

May 13, 2018 - Leave a Response

The ever-capable Judge Labson-Freeman has (as of Friday night) granted the extension of the deadline on any additional fee petitions (presumably while Merck decides whether it will just pay up, without any more fighting). I think it ought to — as there is little left to be gained here — and any additional proceedings will. . . simply enrich the lawyers. [As if that were a bad. . . thing(?). Heh.]

I write a new post this cool, clear Sunday morning though — to note Judge Labson-Freeman has suggested that if it is going to be contested, Gilead might consider bringing it before the Federal Circuit, under Rule 47.7:

. . . .The Court GRANTS the parties’ stipulation. The Court, however, notes that Federal Circuit Rule 47.7 sets forth how a party may request “attorney fees and expenses incurred” before the Federal Circuit.

At this time, the Court is uncertain whether determination of fees on appeal will be remanded to this Court or determined by the Federal Circuit.

PURSUANT TO STIPULATION, IT IS SO ORDERED.

May 11, 2018. . .

Now you know — and a most joyous Mothers Day — to all the biological, and step-, and by-proxy- moms on the planet. To all women, in fact, who have served as a role model — or mentor — to. . . anyone, ever. . . we honor you as well today. Be of good cheer. . . smile.

नमस्ते

A Slight Delay — In Additional Fees Motions: Friday Hep C Case Trivia, Post Gilead’s Win, On Appeal

May 11, 2018 - Leave a Response

Gilead is entitled to — and will almost certainly be awarded — all the fees it spent in defending Merck’s appeal out of USDC Judge Labson Freeman’s wise federal trial level orders, in San Jose, California last year. The question from an overnight filing, is when all that will get underway.

Here it is.

. . . .The parties agree that it is mutually desirable for the parties and the Court to allow Merck sufficient time to consider Gilead’s request for a supplemental award of attorneys’ fees, and to meaningfully meet and confer with Gilead, before Gilead files any motion for an award of supplemental attorneys’ fees.

Accordingly, the parties stipulate and agree that Gilead shall have up to and including May 23, 2018 to file a motion for a supplemental award of attorneys’ fees. . . .

Be excellent to one another.

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