Monday, February 27, 2017

Promising New Phase IIb/III Anti-Viral Results For Merck Candidate Letermovir

My fine erstwhile commenters are up early -- and at it, this morning. I thank them for that -- as I slept in just a tic, after a late night watching a highly entertaining, and (at least at the very end) shockingly goofed up Oscars (poor PwC -- they shouldn't be blamed, but they likely will be). [Nice karma, I guess -- now that "Moonlight" will get more attention for it, though -- and be in every book of entertainment history, henceforth.]

Overnight, Merck has announced the previously-telegraphed restatement of 2016 Q4 results, to reflect the $2.9 billion charge we mentioned last week -- but that should have little impact in NYSE trading, as it is well-factored in.

Also overnight, Kenilworth announced nice results on an anti-viral candidate -- in reducing bone-marrow transplant (cancer-related) mortality rates. So Merck will file with FDA on the agent later this year. From Phil Taylor, at FierceBiotech, then -- a bit -- but do go read it all:

. . . .The phase 3 test looked at how well letermovir was able to prevent cytomegalovirus (CMV) infections in adults undergoing a bone marrow or hematopoietic stem cell transplant (HSCT), a procedure typically used for patients with serious hematological cancers. All patients were seropositive for the virus—meaning they had been exposed to it before—but had no active infection.

CMV is a common virus and usually causes no harm, but when immunity is lowered as in HSCT can cause serious complications including organ damage and failure. Some patients carry CMV before transplant, while in others the virus hitches a ride with the transplanted cells.

The results showed that 37.5% of patients treated with letermovir developed CMV by week 24, compared to 60.6% for a matched placebo group. And Merck's drug also led to lower all-cause mortality at 24 weeks, at 9.8% compared to 15.9% for placebo, which was according to lead investigator Francisco Marty, M.D., of the Dana-Farber Cancer Institute told OncLive was "very compelling and interesting. . . ."

Now you know. Onward, with a flummoxed Oscars-infused smile, on a sunny but crisp morning here -- be excellent to one another. . . .


Saturday, February 25, 2017

An Update: Straight Outta' Brooklyn -- From USDC EDNY Hearing On 45's Muslim Ban -- Ban Now Indefinitely Suspended...

Yesterday, there was argument -- on a pre-scheduled motion -- in this important piece of federal "public interest"litigation, before the very able Judge Amon.

At the conclusion of the hearing, it was agreed by all that no new briefing will occur (and likely little else) -- until Mr. Trump issues a new executive order, on the topic. That may come next week -- but we heard that last week, about this week. even so -- it matters little. The upshot is that his Muslim Ban remains indefinitely suspended -- and the government has now agreed with this -- until any new order is vetted by the court, thus:

. . . .Oral argument held on February 24, 2017. . . .

As stated on the record, Respondents will inform counsel for Petitioner as to which individuals on the list that was recently provided were admitted into the United States. Petitioners' counsel will provide Respondents with a list of names of individuals that they believe were not included on the list so that the Respondents may investigate the matter. Counsel for Respondents and Intervenor Plaintiff requested to adjourn the present briefing schedule regarding a potential motion to dismiss the Intervenor Plaintiff's complaint. The request was granted.

The parties will submit a new briefing schedule, if necessary, within seven days after a new Executive Order is issued. . . .

If and when 45's new order issues -- I would expect that within hours this court will assert jurisdiction in this pending 17-480 litigation, to temporarily restrain it from going into effect. The DoJ and the court seem to have agreed that this will be the case. No need to start a new proceeding -- since the government claims the new one replaces and repeals the old one. We shall see. Off now, to a warm afternoon's bike ride. Onward.


Friday, February 24, 2017

Still A Long Path Through A Rather Brambly Wood, Ahead -- But It Will Likely Be Obamacare -- Just By Another Name...

As the reality dawns, luminous and clear, in town hall meetings across the nation, that sizeable majorities of actual voters (both R and D) favor the ACA and Medicaid expansion -- elected Congresspeople -- even some of those in Mr. Trump's so-called loyal camp -- are designing something that looks to be a remarkably recognizable cousin of. . . wait for it -- Obamacare.

Welcome to the new reality folks. As I said a few times since November 2016, a goodly chunk of the ACA's best parts are unlikely to see much change at all. Per this evening's Washington Post, then:

. . . .Now, as the House begins to hone details of its legislative proposal, a possible compromise has emerged. It would temporarily keep federal dollars flowing to cover almost the entire cost of the roughly 11 million Americans who have gained Medicaid coverage but would block that enhanced funding for any new participants.

At the same time, the GOP approach would open a fresh spigot of aid for the states — all but one of which has a Republican governor — that eschewed the additional Medicaid money because of their elected officials’ antipathy to the law. This extra aid would probably go to hospitals with a large share of poor and uninsured patients.

The Solomon-like strategy is an attempt to calm fears of Republican governors in expansion states that abolishing the 2010 law would cost them hugely, while also satisfying new demands for equity from other GOP governors who opposed the expansion. ­Details of how the plan’s dual elements would be implemented, including their specific time frames and funding totals, are still coming together in the House Energy and Commerce Committee. . . .

And now you know. Quite a distance yet to traverse, but encouraging just the same.

And so, we have nothing but ear to ear grins, as the fun approaches -- be wonderful to one another, she would have wanted it that way. . . .


Thirty Years Ago, This Week... Out Of Hydrus -- A VASTLY POWERFUL Flash Of Starlight Reached Earth: First Fully Recorded Super-Nova

This sort of arriving star stuff still gives me goosebumps, now thirty years on -- as I saw it originally from Tim's backyard telescope in the Rockies, that night in 1987, on a trip home. . . smile. [Click at right to enlarge.]

Here is the full NASA page -- and a bit:

. . . .To commemorate the 30th anniversary of SN 1987A, new images, time-lapse movies, a data-based animation based on work led by Salvatore Orlando at INAF-Osservatorio Astronomico di Palermo, Italy, and a three-dimensional model are being released. By combining data from NASA's Hubble Space Telescope and Chandra X-ray Observatory, as well as the international Atacama Large Millimeter/submillimeter Array (ALMA), astronomers — and the public — can explore SN 1987A like never before. . . .

It was visible to the naked eye, even across an unfathomably vast black ocean of space-time, and it took hundreds of thousands of years for the light to reach us. So, in a sense, we were looking backward, into a time machine, those first nights in 1987 -- with our backyard mountain-top telescope. Whoosh.

Fascinatingly (and, as Einstein and Hawking had correctly predicted), a pulsing pair of anti-neutrino bursts reached Earth, and were recorded, just a bit ahead of the light's arrival. Those little neutrino pulse-monsters were not delayed, as the light-waves were, since the light took a tic to break through to the surface of that exploding star (dubbed 1987A) and head outward toward us -- from the Large Magellanic Cloud. . . . Now, there is I think an allegorical lesson here, in staying on course, and not delaying travel toward one's beloved -- as the one that does -- will first arrive, and with a satisfied grin, too. . . now I'm off for the weekend, grinning just the same. . . .


And, From "Friday's Foolishness" Dept. -- At The Other End Of The Spectrum: Micro-Cap Edition...

We will post on an entirely unrelated development (on another small NASDAQ tech company we cover, at a separate property) -- as it showcases the pain of repeatedly overpriced earlier equity rounds -- which inexorably then lead to a "hard down" highly dilutive later equity round (i.e., today's private placement). It is captioned "'Down Round' Ugliness: Mattersight Agrees To Sell Another 20 Per Cent Of Itself, For About Half The Price Of The Last Round."

[UPDATED -- the stock opened at $3.30 (i.e., down sharply from yesterday's close, and down even more -- for the week), but now it is likely C-H will stabilize trading. MATR is flat, on medium volume now, well into the first hour. Applicable SEC/NASDAQ offering "stabilization" rules prevent a market maker/placement agent from being an unsolicited "uptick" trader in the first half hour, or the last half hour. Now you know.]

Frankly, I didn't think the company would pull the trigger here, until after the investor conferences -- but this says the team wouldn't (otherwise) be in compliance with quarter end Hercules (lender) covenants -- without closing the $16 million equity offering. [My educated hunch would be that the "unrestricted cash balance" -- at the end of Q1 2017 would be below $7.5 million, in violation of the Hercules covenants. So, the company is selling equity to bolster "unrestricted cash" levels, here. This buys Mr. Conway only a few quarters of relief -- unless organic revenue growth (without price claw-back) really takes off.]

This need for equity was repeatedly mentioned -- about 20 separate times -- on our blog, from about August 2016 to yesterday (see below thumbnail graphic). But the pricing is worse than I would have guessed, for the company.

This pricing is at about half of the per share price for the last $16 million raise, in mid-2015. Now that's a down-down-down round, for ya'! Ouch.

Also, frankly -- management is buying only 100,000 shares, in for under 2 per cent of the total -- at $3.45. That's ugly. Now, if I were Mr. Gomes (i.e., an open market purchaser yesterday), I'd be furious. He could have bought at $3.00 a share, but had to pay $3.45 or so.

More in a minute, with graphics -- but here is the just-filed SEC Form 8-K. Ugly. [And... Craig-Hallum pockets a $1 million placement agent's fee, for its trouble. Was its highly bullish research reporting conflicted, when it was touting MATR's future last year at this time -- at around $5/share, on the NASDAQ OTC? I'll let the readers decide.]

A rational investor would expect the stock to open at around $3.20 this morning. Here's a bit:

. . . .On February 23, 2017, Mattersight Corporation, a Delaware corporation (“the Company”), entered into a definitive purchase agreement (the “Purchase Agreement”) for the sale of 5,328,187 shares of its common stock (the “Shares”) to certain investors and certain officers and directors (collectively, the “Purchasers”) in a private placement (the “Offering”). Under the terms of the Purchase Agreement, the Company expects to raise approximately $16.0 million in gross proceeds by selling 5,228,187 Shares to certain investors at a price of $3.00 per share and by selling 100,000 Shares to certain officers and directors (including certain of their affiliates) at a price of $3.45 per share. The Offering is expected to close on March 1, 2017, subject to the satisfaction of customary closing conditions. . . .

So management only bought just under two per cent of the offering. Not a striking show of confidence. At $3.45. Ugh. Expect the Form 10-K to disclose that price clawback I've been mentioning.

And what should we think about the CTO being a big open market seller, right ahead of this offering? Ugly, cubed. Wow. Be careful out there.

[Just some Friday fluffiness/space-filler, truth told. . . along with an additional reworked celestial masthead, for the weekend of wonders, doubtless in store. . .dancing, and more. . . . smile.]


Thursday, February 23, 2017

Breaking: Kenilworth Takes A Pre-Tax $2.9 Billion Charge -- On HCV Prodrug Candidate Acquired From Idenix...

Ouch. Even though it is only $1.9 billion on an after tax basis, this is a profound disappointment. Coupled to the loss in California's USDC, of last summer, this acquisition looks entirely. . . "-vincible". And yes, that will leave a mark -- as there may still be additional write downs in the Idenix acquired-asset base.

More in a moment, including graphics [now done baking, at right!] -- but here is the just filed SEC Form 8-K text:

. . . .On February 17, 2017, Merck determined that it will record an intangible asset impairment charge related to the research program for MK-3682, uprifosbuvir, a nucleotide prodrug in clinical development that is being evaluated for the treatment of hepatitis C virus (HCV) infection. Uprifosbuvir was obtained in connection with the 2014 acquisition of Idenix Pharmaceuticals, Inc.

The Company determined that recent changes to the product profile, as well as changes to its expectations for pricing and the market opportunity, taken together constituted a triggering event that required the Company to evaluate the uprifosbuvir intangible asset for impairment. Utilizing market participant assumptions, and considering different scenarios, the Company concluded that its best estimate of the current fair value of the intangible asset related to uprifosbuvir was $240 million, resulting in the recognition of a pre-tax impairment charge of $2.9 billion ($1.9 billion after taxes), which will be reflected in the Company’s 2016 results. Merck’s previously reported fourth-quarter 2016 generally accepted accounting principles (GAAP) diluted earnings per share (EPS) were reduced from $0.42 to a loss of $0.22, and full-year 2016 GAAP EPS were reduced from $2.04 to $1.41, reflecting the impact of the impairment charge, partially offset by other adjustments which increased GAAP EPS for both the fourth and full year of 2016 by $0.04. The Company’s previously reported fourth quarter and full year non-GAAP EPS remain unchanged.

The Company continues to evaluate options with respect to the uprifosbuvir clinical development program and will monitor the remaining $240 million intangible asset for further impairment. . . .

Now you know. Try to slow down, and breathe a bit -- it will pass. . . . I promise it will -- smile. Onward, on a rainy, cold evening.


The Latest Motions -- In Mr. Shkreli's Felony Fraud Trial In Brooklyn -- Are Increasingly... Salacious.

And so, ported over from another of my properties, as of one week ago -- here is a searing preview of Mr. Greebel's evidence (Mr. Shkreli's former corporate counsel, while at Retrophin) against Mr. Shkreli's defense of "advice of counsel":

A pair of dueling motions to sever were filed last Friday afternoon.

In truth, they aren't dueling at all -- as to the propriety of severance. Both argue it is clearly appropriate. And (as I've long-predicted) the able Judge Matsumoto in Brooklyn will grant the severance.

The motions are widely divergent, however, on the critical issue of which of the defendants was the "mastermind" -- of the allegedly fraudulent schemes that led to their nearly simultaneous arrests, and eight count felony indictments in Manhattan, in December of 2015. For pure salacious details, I recommend reading Mr. Greebel's first -- it is a weighty 44 page PDF file.

At the bottom, I've linked Mr. Shkreli's -- it makes for far less interesting reading. [And separately, I should note that Mr. Shkreli harshly criticized Cooley and Akin Gump (without providing any evidence as to why he thinks poorly of them), in his Facebook posts of about ten days ago. Cooley of course, represents Retrophin. Do your own math.]

In any event, here's a bit -- from Mr. Greebel's (there is much salacious detail in the filing I am not repeating here -- read it yourselves):

. . . .In light of the mutually antagonistic defenses of Mr. Greebel and Mr. Shkreli, there will be no realistic way for a jury to find both defendants not guilty. In order to believe Mr. Greebel’s core defense, the jury will have to disbelieve Mr. Shkreli’s core defense; and, in order to believe Mr. Shkreli’s core defense, the jury will have to disbelieve Mr. Greebel’s core defense. The opposing defenses of Mr. Greebel and Mr. Shkreli go far beyond mere “finger pointing.” Mr. Greebel’s defenses require him to offer evidence at trial of Mr. Shkreli’s lies, material omissions, and deception. In a joint trial, that will turn Mr. Greebel’s counsel into another prosecutor of Mr. Shkreli. . . .

Mr. Greebel will be offering into evidence certain post-arrest statements made by Mr. Shkreli that exculpate Mr. Greebel, but inculpate Mr. Shkreli. And the government and Mr. Shkreli will likely attempt to keep them out of evidence altogether. Moreover, Mr. Greebel will likely be moving to preclude the admission of certain testimonial statements of Mr. Shkreli to law enforcement and the SEC that would not be admissible as evidence in a separate trial against Mr. Greebel. . . .

As demonstrated below, Mr. Shkreli’s post-arrest conduct has been nothing short of bizarre and, in the absence of a severance, will present a serious risk of depriving Mr. Greebel of a fair trial. According to his own stated intentions, as corroborated by his well-publicized post-arrest actions, Mr. Shkreli is purposely creating a circus-like atmosphere pursuant to an improper and prejudicial plan to disrupt the trial and achieve jury nullification along the lines of, in Mr. Shkreli’s own words, “OJ Simpson [and] Casey Anthony.” As the trial approaches and gets underway, and both the government and Mr. Greebel attack Mr. Shkreli’s story, it is a near certainty that Mr. Shkreli will take actions and make statements to destroy the integrity of the court proceedings to detract from the applicable evidence and the law. . . .

Mr. Greebel’s core defense will be based, in substantial part, on the following arguments that are antithetical to Mr. Shkreli’s defense: (1) Mr. Shkreli lied to Mr. Greebel and other attorneys at Katten Muchin; (2) Mr. Shkreli failed to disclose material information to Mr. Greebel and other attorneys at Katten Muchin; (3) Mr. Shkreli misrepresented on multiple occasions to third-parties that Mr. Greebel had offered or provided certain advice when in fact Mr. Greebel provided the opposite advice; (4) Mr. Shkreli misrepresented to others that he had obtained certain legal advice from Mr. Greebel when, in fact, Mr. Shkreli had not conferred with Mr. Greebel at all; (5) Mr. Shkreli deceived Mr. Greebel and other attorneys at Katten Muchin and misused them as pawns in fraudulent schemes unbeknownst to them; and (6) Mr. Shkreli has a long-term, pattern and practice of blaming others, including Mr. Greebel, for his own misconduct. . . ."

Charming. I do not know -- and cannot discern -- whether Mr. Greebel acted in a culpable manner here; I will await a jury decision on that score -- but I will now say that Mr. Greebel's legal team is almost certainly talking about a plea deal, from time to time -- with the AUSAs. That would be a death-knell to Mr. Shkreli's chances of avoiding prison time, in my experienced opinion.

Here is Martin's motion to sever -- some 23 pages.

Enjoy. Do read both -- for a full picture. Personally, I think it says as much about the counsel, as it does about the one counseled. I think snap reactions often belie deeper wounds. . . . Onward. Mr. Shkreli will go to trial (alone) in late June, and he will see time in a federal prison -- mark my words.


Wednesday, February 22, 2017

A Potential Human Anti-Viral Science Coup: Zika Vaccine Candidate Now In Human Trials...

This indeed is another hopeful sign -- a public/private collaboration (with US and UK partners, as well) has resulted in the development of a broad range vaccine candidate for mosquito-born viral diseases -- including, of course Zika.

As of yesterday, that vaccine candidate is in human trials in Bethesda, Maryland -- in a study being run by the US NIH. Here's a bit, from Medical Xpress:

. . . .The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has launched a Phase 1 clinical trial to test an investigational vaccine intended to provide broad protection against a range of mosquito-transmitted diseases, such as Zika, malaria, West Nile fever and dengue fever, and to hinder the ability of mosquitoes to transmit such infections.

The study, which is being conducted at the NIH Clinical Center in Bethesda, Maryland, will examine the experimental vaccine's safety and ability to generate an immune response. . . .

I wish you all -- of good will -- nothing but the best, in all things. Do treat others as you would wish to be treated. . . smile. With this candidate, we are all our brothers' and sisters' keepers. . . . regardless of geopolitical borders.


BREAKING: Three (Of Seven) Likely Habitable Worlds -- In One Distant Solar System Called Trappist 1 -- Just Uncovered, Per NASA...

[I guess that graphic should refer to the plural case. Smile -- no time to fix it, this day. It will stay as is until late tonight.] The assembled astrophysicists are saying it is no longer "if" -- but when -- we will prove a liquid water-world (or several of them!), in the habitable zone, in a single faraway system.

In fact, later in the webcast, it was revealed that all seven could potentially harbor life. Even so, three look highly likely -- and when Webb comes online, we may be able to detect the spectral signatures of an organics-ladened haze around one or more. That would be. . . jaw-slacking.

NASA webcast has concluded is underway now. . . .

. . . .More soon late tonight, but the so-called Trappist Seven are warm rocky worlds, that orbit a sun less bright than ours -- and they are only 39 light years away from us, in the constellation we call Aquarius. . . .

Be excellent to one another -- far and near.


Tuesday, February 21, 2017

Told Ya' So! Petitioners In 17-CV-480 (USDC, NYED) Get Their Nationwide "Miranda-Style" Disclosure Order -- From Federal Courts In Brooklyn, Tonight...

Well -- that didn't take very long (just as I said yesterday morning). On a day that saw Mr. Trump begin to implement new federal rules related to immigration and deportation (entirely separate from these Muslim banning, and now, court enjoined executive orders) -- the able US District Court Judge Amon, sitting in Brooklyn tonight ordered the Trump Administration to furnish a complete list of those held under the orders by this Thursday at 5 PM EST, latest.

This, my friends, is how the system of ordered liberty works. Here's tonight's concluding paragraph, from the order:

. . . .Accordingly, Respondents are ordered to provide Petitioners, by February 23, 2017 at 5:00 PM, with a list of all individuals with refugee applications approved by U.S. Citizenship and Immigration Services as part of the U.S. Refugee Admissions Program, holders of valid immigrant and non-immigrant visas, and other individuals from Iraq, Syria, Iran, Sudan, Libya, Somalia, and Yemen legally authorized to enter the United States (i.e. putative class members) who, at any time during the period from 9:37 PM on January 28, 2017 until 11:59 PM on January 29, 2017, were being held, including being processed, by U.S. Customs and Border Protection pursuant to the EO. Ordered by Judge Carol Bagley Amon on 2/21/2017. . . .

I would expect entirely new federal lawsuits will be filed in the next day or two (by the ACLU and FAIR, among others), on those other new rule changes -- as at least to my eye, they seem infirm from a constitutional "due process" point of view. People already here in America -- even those who the government alleges are undocumented, entirely -- have earned some notice and opportunity to be heard rights -- under our Fourteenth Amendment. That is, in the words of the Supremes -- to all of these people, "at least some process is. . . due."

Mr. Trump's changes announced today look to fall well-short of that standard, to my experienced eye. And so. . . "see you in court, Mr. Trump" (again!). . . I am all smiles tonight. . . despite his venial attacks on people with little clout.


Fast Fred Hassan Protégé Bob Bertolini Added To BMS Board -- In Deal With Activist Investor

All the longer term readers will recall the name. He was CFO of legacy Schering-Plough, until 2010 -- pre-closing of the bust-up (by Merck). Then he was CFO at Bausch + Lomb. But in between, he was added to the boards of some hedge-fund hectored pharma companies. The graphic at right conveys his "travelling salesman's" pedigree -- at least in part. But do know that Fast Fred chose him for his pliability, in my estimation. The more things change, the more they stay. . . the same, it seems.

Here is the early morning bit, from Reuters:

. . . .Bristol-Myers Squibb Co said on Tuesday it appointed three directors to its board in a deal with activist investor Jana Partners LLC.

Bob Bertolini, former Bausch & Lomb CFO, Matthew Emmens, former Vertex Pharmaceuticals Inc CEO, and Theodore Samuels, who is on the boards of Perrigo and, have been added to the board.

Bristol-Myers, which also announced a $2 billion accelerated share repurchase program, said the appointments would temporarily increase the size of the board to 14. . . .

Net, net -- the stock buy-back at least will be good for longer term BMS stockholders. Now you know. Onward, on a eerily gray 65 degree Chicago day. . . smiling just the same, for the world is chock full of new science wonders -- and celestial joys. . . .


Monday, February 20, 2017

More News -- On Recently-Uncovered Exo-Planets -- At NASA, Come 1 PM EST Wednesday...

I will tune in -- for the NASA-cast Wednesday afternoon results -- due to be published in a new Nature scholarly paper. . . but those few media folks hyping it as new evidence of extra-terrestrial life are likely. . . off the mark.

Here is the NASA release, from earlier today:

. . . .NASA will hold a news conference at 1 p.m. EST Wednesday, Feb. 22, to present new findings on planets that orbit stars other than our sun, known as exoplanets. The event will air live on NASA Television and the agency's website.

Details of these findings are embargoed by the journal Nature until 1 p.m.

Limited seating is available in the NASA TV studio for media who would like to attend in person at the agency’s Headquarters at 300 E Street SW in Washington. Media unable to attend in person may ask questions by telephone. To attend in person or participate by phone, media must send an email with their name, affiliation and telephone number to Dwayne Brown at by noon Feb. 22.

Media and the public also may ask questions during the briefing on Twitter using the hashtag #askNASA.

The briefing participants are:

· Thomas Zurbuchen, associate administrator of the Science Mission Directorate at NASA Headquarters in Washington

· Michael Gillon, astronomer at the University of Liege in Belgium

· Sean Carey, manager of NASA's Spitzer Science Center at Caltech/IPAC, Pasadena, California

· Nikole Lewis, astronomer at the Space Telescope Science Institute in Baltimore

· Sara Seager, professor of planetary science and physics at Massachusetts Institute of Technology, Cambridge

A Reddit AMA (Ask Me Anything) about exoplanets will be held following the briefing at 3 p.m. with scientists available to answer questions in English and Spanish. . . .

Now you know -- and I should note that Dr. Seager is a renown expert in, among other things, how to identify bio signatures in exoplanet atmospheres. So. . . who is out there, oh you twisty copper-colored denizens of the Cosmos? Who indeed? Smile. . . . [Ahem. It is highly unlikely that life has been observed.]


Meanwhile, In Brooklyn, This Morning... Of Miranda-Style Rights...

The plaintiffs have requested that the federal trial level courts in Brooklyn order Mr. Trump to both inform all aggrieved parties of their US constitutional, statutory and regulatory rights -- and provide the lawyers for plaintiffs with contact details for each person refused entry since the date of the executive order -- so that the status of each of those persons may be evaluated, regardless of where they have been sent off to, by Mr. Trump's agents. [Sort of a Miranda warning, for all affected persons, if you will.]

I predict the plaintiffs will win the vast bulk of this motion. And, here is the full filing, from just this morning -- and a bit:

. . . .[T]here is significant evidence of systemic coercion, and many if not most or nearly all of the individuals who were excluded want at least the opportunity to return — as evident by the many individuals who have already returned despite the ordeal they suffered during their initial exclusion. See Dkt. 53-1 at 15-17 (describing government’s coercive tactics outlined in declarations of removed individuals).

Petitioners obviously do not argue that any class member must come back; but the government can and should facilitate the identification of class members and their return if they wish. . . .

For the balance of the day, since I am off-grid with a client -- I've revised my masthead to reflect what science looks like, on "a day without immigrants". President Washington certainly would agree -- our 240 years of shared history is. . . almost to a person, immigrants' history. Here endeth the sermon.


Sunday, February 19, 2017

As 45 Readies Yet Another Meaningless, Show-Boating, Impotent Anti-Immigrant Order...

Please watch this. Please do -- it is very short -- and makes a cogent, and powerfully poignant counterpoint:

. . . .Diane Von Furstenberg: I am an immigrant, and America has been very good to me. . . .

We Americans are better than this, Mr. Trump -- we all are. Stop with all the hateful (but ultimately impotent) show-boating -- this new one, too will be stricken in the courts. Do mark my words. And I bid all of good will -- all good Americans, documented and not so -- a good night -- all us of the huddled masses -- whose progenitors yearned to breathe free. . . .


Saturday, February 18, 2017

Juno Mission Update: Orbiter To Stay In Safer, More Distant Orbital Loop

To be clear -- NASA will complete all the expected science at Jupiter, but will do so over a loner time frame.

Due to the valve glitch we discussed earlier, it will be safer for the spacecraft not to trim its orbit -- in short, not to fire its engines -- until the final dip, some years from now.

There appears to be some real concern about funding for the later stages of the mission -- under the new Administration -- since the longer orbital period will entail a multi-years-longer ground-based crew allocation. So some of the later passes may become mission extender budget items. Here's the full release -- and a bit -- form the agency that gave us Hidden Figures:

. . . .NASA’s Juno mission to Jupiter, which has been in orbit around the gas giant since July 4, 2016, will remain in its current 53-day orbit for the remainder of the mission. This will allow Juno to accomplish its science goals, while avoiding the risk of a previously-planned engine firing that would have reduced the spacecraft’s orbital period to 14 days.

“Juno is healthy, its science instruments are fully operational, and the data and images we’ve received are nothing short of amazing,” said Thomas Zurbuchen, associate administrator for NASA’s Science Mission Directorate in Washington. “The decision to forego the burn is the right thing to do – preserving a valuable asset so that Juno can continue its exciting journey of discovery.”

Juno has successfully orbited Jupiter four times since arriving at the giant planet, with the most recent orbit completed on Feb. 2. Its next close flyby of Jupiter will be March 27. . . .

Smiling, as I too twist through a clear, bright and copper colored celestial-flight focused morning -- preparing a huge winter bar-b-que. . . [but of course, there is no such thing as climate change. . . on a 70 degree February Saturday in Chicago. Wow. Just. . . wow.]


Thursday, February 16, 2017

Newly-Launched Merck Digital Arm -- Ilúm -- Looks To Reduce In-Hospital Sepsis Costs

This is technically just an unincorporated operating group within mother Merck, apparently, but the recently-launched Ilúm Health Solutions (pretentious accent on the "u" included!) does have a laudable goal.

Sepsis infections represent (on a per patient basis) the most expensive in-patient non-surgical treated condition (at $21,000 per patient estimated average) most general providers face. This is due to the more than occasionally spotty early-diagnosis, and drug treatment protocols -- which tend to vary across hospitals -- especially away from large metropolitan teaching-hospital settings.

This Ilúm group of software tools (piloted in a hospital in Metairie, Louisiana -- just northwest of New Orleans), using existing legacy hospital IT data sets -- will seek to alleviate that set of unfortunate circumstances -- by more completely standardizing anti-microbial and anti-biotic protocols, and driving compliance with follow-up monitoring of the patients -- across the entire hospital, when any likely-septic patient is admitted. Here's a bit of the release:

. . . .ILÚM Insight™ – ID leverages data within existing hospital IT systems to promote optimal decision making and appropriate use of antimicrobials through its clinical decision support (CDS) system and Command Center (an intuitive data dashboard). These solutions enable case monitoring and prioritization—on an individual and aggregate level based on disease state—and promote early recognition of infectious diseases, appropriate interventions, and adherence to evidence-based clinical pathways. They also provide automated outcomes reporting that is configured to hospital-specific initiatives to track quality program performance.

In 2015, ILÚM initiated a collaboration with East Jefferson General Hospital (EJGH), a 424-bed general medical and surgical hospital in Metairie, La., to pilot ILÚM’s CDS system with an initial focus on improving the impact of the hospital’s quality program for sepsis care improvement. Sepsis is a potentially life-threatening complication of an infection, resulting in 750,000 deaths in the United States and more than $20 billion in aggregate costs annually, with studies demonstrating that hospitals spend approximately $34,000 caring for each patient with severe sepsis. . . .

Now you know. I might also observe that this is the "software push" -- to help drive appropriate use of the Cubist-acquired (Cubicin® -- now also available in generic form) line of antibiotics, into wider use, inside providers across the nation.

Note: blog coverage will become spotty starting this evening, and lasting through the weekend, as I make airport runs around 6 PM EST. Onward.


Wednesday, February 15, 2017

Federal Propecia®/Proscar® MDL Bellwether Trials: Schedule Update

The first bellwether case -- in the first tranche of Propecia®/Proscar® trials -- in New York's Eastern District (Brooklyn) federal MDL remains on track, for a March 2018 trial date. That's the abidingly-consistent narrative line, here.

But in the intervening weeks since my last update, one more case was dismissed by the plaintiff -- and now a replacement case (called Case Z here) has been picked, as of last night. A note on nomenclature, then -- I'll endeavor to redact all case names from all my future additional reporting -- out of respect for the limited remaining privacy interests of the plaintiffs. Many names are listed in actual court pleadings and orders, but I'll strive to omit them unless absolutely required for clarity. Here's the adjusted schedule -- in amended Procedural Order 15:

. . . .On or before February 15, 2017, Merck will disclose in writing the identities of its experts as required by Fed. R. Civ. P. 26(a)(2)(A) and will serve the reports and other materials as required by Fed. R. Civ. P. 26(a)(2)(B), for [Case H], [Case D], and [Case J], including case specific reports. . . .

On or before March 15, 2017, plaintiffs will disclose rebuttals expert reports for [Case H], [Case D], and [Case J], if any. . . .

On or before May 15, 2017, plaintiffs will disclose in writing the identities of their experts as required by Fed. R. Civ. P. 26(a)(2)(A) and will serve the reports and other materials as required by Fed. R. Civ. P. 26(a)(2)(B), for [Case Z], including case specific reports. . . .

On or before June 15, 2017, Merck will disclose in writing the identities of its experts as required by Fed. R. Civ. P. 26(a)(2)(A) and will serve the reports and other materials as required by Fed. R. Civ. P. 26(a)(2)(B), for [Case Z], including case specific reports. . . .

Case Z is the newest replacement bellwether case -- and so it is on a slightly extended time track, as to getting discovery completed. Now you know, with a busy off-grid end of week looming, come Thursday night through Sunday night (and likely sublime celestial events, come Saturday night) -- fireworks, as she loved grilled Gengis Khan Mongolian ribs, and fireworks. . . for it is to be unusually warm here, that night. Smile. . . . Onward. Ever, onward.


Tuesday, February 14, 2017

Some Mixed Clinical Trials News, Out Of Kenilworth Tonight...

At least some parts/arms of the company's ongoing Alzheimer’s BACE1 inhibiting candidate studies have seen new enrollment ended -- i.e., have been halted for futility.

But Merck is continuing other parts, and announced decent results in an unrelated HIV-1 candidate Phase III study, tonight. Here's the materially important bit (the rest ought not move Kenilworth's stock much either way, on the NYSE, in the morning tomorrow):

. . . .Merck. . . announced that it will be stopping protocol 017, also known as the EPOCH study, a Phase 2/3 study evaluating verubecestat, an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in people with mild-to-moderate Alzheimer’s disease (AD). Merck is stopping the study following the recommendation of the external Data Monitoring Committee (eDMC), which assessed overall benefit/risk during a recent interim safety analysis, and determined that there was "virtually no chance of finding a positive clinical effect." The eDMC noted that safety signals observed in the study "are not sufficient to warrant stopping study 017," and recommended that protocol 019, also known as APECS, which is evaluating verubecestat in people with prodromal Alzheimer’s disease, continue unchanged. Results from protocol 019 are expected in February 2019. Results from EPOCH will be analyzed and presented at an upcoming scientific meeting. . . .

Our prior November 4, 2016 (smile) backgrounder here. Now you know -- onward, for some sweet silly fun. . . .


Trivial Disclosures Dept.: Capital World Investors Upped Merck Stake Slightly In 2016 -- To 5.1 Per Cent Of All Outstandings

As the year-end large holder (north of 5 per cent) SEC reports continue to emerge -- at the EDGAR filing window, we see (via an overnight Schedule 13G) that long term holder Capital World Investors (and affiliates) upped its stake in Merck modestly during 2016, compared to declines at year end of 2013, 2014 and 2015:

. . . .Amount Owned (12/31/2016):

141,332,476 Shares (5.1%). . .

Now you know. Onward.


Monday, February 13, 2017

Just Read This Memorandum Opinion -- Top To Bottom

More good news for believers in our system of ordered liberty -- in Alexandria, Virginia tonight -- in Judge Brinkema's US District (trial level) courtroom, the following very cogent 22 page opinion (and a related order) was entered, against Mr. Trump's would-be Muslim Ban.

It is a preliminary injunction -- and so now there are. . . two. Now you know. Nothing more really need be said, though I think 45 is likely to appeal.

This is an early Valentine's present to all who believe in our First Amendment's Free Exercise Clause. In view of this opinion, Mr. Trump's appeals won't ultimately matter -- his whole initiative here. . . is now a dead letter.