Thursday, August 17, 2017

For The Rest Of Today And Tomorrow, I Will Try To Forget 45 Exists -- And Think of My Friends In Barcelonetta...


Frankly, Trump's idiotic tweets about "our ["OUR"?!] beautiful statues and monuments. . . ." (for me) now fall on entirely. . . deaf ears.

Thirteen people are dead. Murdered, on the Ramblas -- where I'd taken many an afternoon and evening stroll -- with my then growing family.

[Two smallish versions of some peaceful pictures I took there -- six years ago, this week -- in August of 2011, appear at right. Two of literally. . . thousands.]

To this moment, Mr. Trump has not yet contacted the family of the murdered Heather Heyer (one of his own fellow citizens, murdered by a home-grown white supremacist terrorist, in just the same way that the people of Barcelona have been killed and maimed, this day) -- but we all know he will be all over the place, in calling this mayhem in Spain out -- as terror.

That is disgusting. And so from him. . . I will look away. . . . I will look across, and away -- to the azure Mediterranean coast, and the '96 Olympic Village beaches -- and the soft warm salt air, there -- and think of my friends. I will call them, email them and text them -- to let them know I care. And I will hope that my thoughts and meditations find them well, even in their sadness. That is my hope. Hope.

नमस्ते

Status Of Merck's Recovery From "Not Petya" Hack/Cyber-Attack: SEC Form 10-Q


I have been a little too busy with my day gig to get back to Merck's SEC filed Form 10-Q for the most recent quarter, and post this.

But as I have a quiet moment here, on this gray but clearing early morning -- with my coffee, I'll load this up.

As I earlier guessed, the API operations have been deeply impacted by the ransom wear attack -- it locked out the systems needed to monitor, for example, the bulk vaccine pre-cursor stock -- in my opinion. I have no non-public inside information, here -- but given the way the Hep B vaccine is created, the API computer monitoring operations being out would be. . . crippling. In fact, if I am right about that speculation, GMP would require that the vast bulk of the raw API be discarded, and the entire process restarted, with all new pre-cursors, to ensure purity and safety. And so, do read the bolded parts below, closely (from page 29 of the Form 10-Q):

. . . .On June 27, 2017, the Company experienced a network cyber-attack that led to a disruption of its worldwide operations, including manufacturing, research and sales operations. While the Company does not yet know the magnitude of the impact of the disruption, which remains ongoing in certain operations, it continues to work to minimize the effects.

The Company is in the process of restoring its manufacturing operations. To date, Merck has largely restored its packaging operations and has mostly restored its formulation operations. The Company is in the process of restoring its Active Pharmaceutical Ingredient operations but is not yet producing bulk product. The Company’s external manufacturing was not impacted. Throughout this time, Merck has continued to fulfill orders and ship product.

The Company is confident in the continuous supply of key products such as Keytruda, Januvia (sitagliptin) and Zepatier (elbasvir and grazoprevir). In addition, Merck does not currently expect a significant impact to sales of its other top products; however, the Company anticipates that it will have temporary delays in fulfilling orders for certain other products in certain markets. Merck does not currently expect a significant impairment to the value of intangible assets related to marketed products or inventories. Full resumption of affected operations will take time and the Company will incur expenditures related to remediation efforts. The Company has insurance coverage insuring against costs resulting from cyber-attacks. However, there may be disputes with the insurers about the availability of the insurance coverage for claims related to this incident. . . .


That is -- to be fair -- my speculation. But it is speculation informed by long experience. And as to the last bolded bit, I cannot imagine what any business interruption insurer could say that would allow it to avoid covering the direct interruption expenses, from a cyber-attack or ransom wear hack attack loss, here.

Now you know -- onward, to a wonderful traveling, eclipse kissed long weekend!

नमस्ते

Wednesday, August 16, 2017

What Wonders Will The Final Month -- And Four Orbits -- Reveal? [With A Side Of "Resist"]


Let's listen in on NASA's coverage -- via an overnight ScienceCast:



And, as a bonus -- see last evening's peaceful, easy resistance in Chicago -- at bottom, as 45 doubled down on his support of white supremacists. It all came together in about an hour; and with them, I marched -- at least insofar as it led me to my evening movie in the park. Smile. As we await the Southern Baptists' leadership -- for a truly Christian condemnation of white supremacist domestic terrorism and murder -- I will offer this, penned from the jail-cell, on scraps of paper -- in Birmingham, Alabama in April of 1963 -- by Dr. King:

. . . .I have traveled the length and breadth of Alabama, Mississippi and all the other southern states. On sweltering summer days and crisp autumn mornings I have looked at the South's beautiful churches with their lofty spires pointing heavenward. I have beheld the impressive outlines of her massive religious education buildings. Over and over I have found myself asking: "What kind of people worship here? Who is their God? Where were their voices when the lips of Governor Barnett dripped with words of interposition and nullification? Where were they when Governor Wallace [and candidate Donald Trump] gave a clarion call for defiance and hatred? Where were their voices of support when bruised and weary Negro men and women decided to rise from the dark dungeons of complacency to the bright hills of creative protest?"

Yes, these questions are still in my mind. In deep disappointment I have wept over the laxity of the church. But be assured that my tears have been tears of love. There can be no deep disappointment where there is not deep love. Yes, I love the church. How could I do otherwise? I am in the rather unique position of being the son, the grandson and the great grandson of preachers. Yes, I see the church as the body of Christ. But, oh! How we have blemished and scarred that body through social neglect and through fear of being nonconformists. . . .
And here's a bit, from last evening's spontaneous, peaceful and upbeat marchers, along Washington Boulevard. . . and turning north, onto State Street -- at 6 PM CDT:



[UPDATE: The SBC issued this statement last evening.] Where indeed are the Southern Baptists in denouncing these domestic terrorists? I have given up on our man-child-president. His words are without meaning -- as he proves daily that he means none of them, with any permanence.

Onward, just the same -- beaming toward an eclipse road trip, later this weekend. . . grin!

नमस्ते

Tuesday, August 15, 2017

I'm Tardy With This: Merck Has Appealed The Gilead Legal Fees Award To The Federal Circuit...


Just as we said it might (back in December 2016), Kenilworth has now appealed to the Federal Circuit in DC -- on the issue of the amount of legal fees awarded to Gilead, as a result of Merck's former counsel's "unclean hands". It happened while I was busy on Friday, past. Here is the notice of appeal, as a three page PDF file.

In addition, recall that Merck has appealed to the Ninth Circuit as to the overall disallowance of the $200 million patent damages award, in California's Northern District -- by the able Judge Labson-Freeman. Finally, these same parties are on appeal in Delaware, from Merck's $2.54 billion award, against Gilead. Here's the bit:

. . . .Merck. . . hereby appeal[s] to the United States Court of Appeals for the Federal Circuit from the Order Regarding the Amount of Reasonable Attorneys’ Fees entered in this action on July 14, 2017 (D.I. 489); and any and all adverse rulings (whether oral or written) incorporated in, antecedent to, or ancillary to the Order; and any and all adverse interlocutory orders, judgments, decrees, decisions, rulings, and opinions (whether oral or written) that merged into and became part of the Order, that shaped the Order, that are related to the Order, and upon which the Order is based; including, but not limited to, the Court’s Order Regarding Gilead’s Entitlement to Attorneys’ Fees Pursuant to 35 U.S.C. § 285 (D.I. 457), entered on August 11, 2016, and the Court’s Order Awarding Total Amount of Attorney Fees and Staying Enforcement of Orders on Fees and Costs (D.I. 492), entered August 2, 2017. . . .


Now you know. And in truth, I am beaming this morning, and not just because sweet Cassini has survived another ring plunge, skimming the cloud tops of mighty Saturn. . . .

I am beaming, because I think the tide has turned. I think the leaders of some big powerful businesses are finally calling Mr. Trump out for who he is -- and what he does (and fails to do). And that will be good for our democracy in the longer, and shorter runs. Though there is sure to be more disruption in that near term -- and some of that may be. . . violent. It all starts with Mr. Trump's abject failure -- to lead.

For my part, I am at ease with the notion that Mr. Trump's manifold failures to lead have now led to protesters pulling down Confederate memorial statues around the nation, of their own volition -- when and where they can safely do so. As with civil rights marchers in the 1960s, they will be subject to arrest -- and must accept the consequences of taking an unlawful course of action.

All the while, American history is now marching right past this "lost boy" of a non-popularly elected president. He is increasingly. . . irrelevant. And I am smiling about that as well.

नमस्ते

Monday, August 14, 2017

KUDOS! The Courage Of Standing For Civil Rights -- This Bears Repeating... Well Done, Mr. Frazier!


UPDATED @ 3 PM EDT -- Because Mr. Trump often likes to take credit for the rise in the Dow -- I will simply note that after 45's threats to act against Merck, in retaliation for Mr. Frazier's courageous stand, this morning. . . Merck's stock is actually up almost a dollar on the day, on the NYSE. 45's tweets are increasingly. . . irrelevant. [End, updated portion.]

Small world, that. I have long reported on Mr. Frazier's charitable work -- in freeing an actual innocent, from death row, in Alabama, some years ago (yep -- this is a bro-crush!). So it would come as no surprise that he has resigned from 45's goofy council on manufacturing. [In truth, I have admired him for over 20 years, but blogged on him -- for around ten.]

I give him "big ups" for telling Mr. Trump and -- directly so -- that the primitive in chief's response to the events in Charlottesville was. . . disgusting. [Click each image to enlarge.]

And of course, surprising no one, the small minded Mr. Trump almost immediately lashed out -- by tweet. 45 has thus renewed his threats about pricing on pharmaceuticals. As my lower graphic implies -- Mr. Trump is nothing, if not a ham handed opportunist. Perhaps now Mr. Read will take Mr. Frazier's seat on the administration's council -- though soon enough, he too will be savaged by the primitive in chief.

But let us return to singing full-throated praise -- for Mr. Frazier. I had almost held my breath in anticipation this morning, hoping against hope -- that he would pull the trigger, and tell 45. . . "enough is enough". And he just did.

In history's longer lens, it will almost certainly be a badge of honor, to have been singled out for criticism in a 45 tweet.

I stand with Mr. Frazier -- I hope you will too: I hope we will all call the thing by its name: 45 is a white supremacist enabler, by his refusal to specifically repudiate murders occurring in his name.

Well done, Mr. Frazier -- this is deep purple hero stuff. Thank you, from the bottom of my heart. Thank you.

नमस्ते

Hawaii v. Trump: Ninth Circuit Oral Argument On August 28, 2017 At 5 PM EDT


This will be a watershed argument -- even as it promises to retrace ground already covered. It will also seem like a precursor to the US Supreme Court arguments, on the morning of October 10, 2017.

More of the back-story is here, and some collateral background here -- but this is the full order entered on August 9, 2017:

. . . .Before: HAWKINS, GOULD, and PAEZ, Circuit Judges.

This case shall be set for oral argument on Monday, August 28, 2017, at 2:00 pm in Seattle, Washington. . . .


Now you know -- this cool, cloudy Monday morning finds me trying to shake off the remark of the organizer of the white supremacy rally (that it seems, by his design, devolved into mayhem) over the weekend -- when he claimed a "moral victory" had occurred (who is this monster?), in a press appearance last night.

No sentient, breathing human would call a "car crowd-plowing" domestic terrorism incident, and murder, by one of your own attendees/followers. . . a moral victory.

To the extent Mr. Trump does not denounce this man by his name -- a name I won't ever utter again -- he is both complicit in, and responsible for the mayhem these primitives wreak in his name.

नमस्ते

Scheduling Order Update -- Federal MDL In New Jersey -- On Fosamax®


I am tardy in getting this up. I guess I'm just. . . not feeling it, in truth. Hauntings from the weekend's hatred and murder do weigh me down, this early morning. [Backgrounders from June 2016, here, and a prior April 2014 one, here.]

Here is the full scheduling order, as a PDF.

It really only affects cases joined to the decade old MDL after July 14, 2017.

Now you know -- as a profound sadness dawns here, on Monday. This divisive primitive will never be my president.

नमस्ते

Sunday, August 13, 2017

Other Than The Prior Update, To Friday's Post...


. . .I do not intend to say any more about 45 -- and the white supremacy "winks and nods". When a prominent white supremacy group publicly claims they are (with violence) acting to fulfill Mr. Trump's "promises" -- 45 has a clear duty. . . to disavow these lost souls clearly, and forcefully.

He did no such thing. He is not my President.

नमस्ते

Saturday, August 12, 2017

As The "Final Five" Saturnian Ring Crossings Get Underway...


The "Final Five" ring plunges have begun, on this luminous but clear[ing] dawn. . . .

And while we wait for Tuesday, and word that the One Bar of atmosphere above Saturn's cloud tops -- into which Cassini soon dips -- hasn't ripped the antennae off of this twistily-literate, copper hued, unwastedly-graceful and long legged shepherded moon-lette. . . feel free to watch this three minute NASA video -- on one of the central goals of the mission:





Now you know. Be excellent to one another -- workouts and mountain bike rides -- on this clear, cool and breezy Chicago Saturday, now. . .

नमस्ते

Friday, August 11, 2017

The Primitive In Chief -- Finds Me (Gasp!) Nostalgic For (A Senile) Ronald Reagan...?


UPDATED: 08.12.2017 @ 8 PM EDT -- All of the carnage in Charlottesville -- every bit of it -- is properly to be laid at the feet of this man. He has permitted (both openly, and with "dog whistles" -- in his speeches) white supremacists from the jump. And it took him over five hours -- after his original "law and order" tweet posts -- to offer belated condolences to the family of Heather Heyer, the 32 year old Anti-Alt-Right, pro-inclusion woman marcher murdered today. 45 is. . . a disgustingly racist enabler. [End, update.]

As I hopped on a train, off to the church to be married, 33 years ago this morning, I heard tell of Mr. Reagan's "hot mic" NPR moment -- which was in the middle of the 1984 presidential election cycle. It was -- he later said, at least -- a joke. A very poor joke. But one that dominated weeks of news cycles, about whether he was fit to be President.

I could point to the "pussy grab" remark of the analogous time last summer, but really -- why bother?

What 45 just said by tweet, on the 33rd anniversary of of Mr. Reagan's awful gaffe -- and what he said, in all seriousness -- should be bone-chilling -- at least to anyone who thinks he was ever fit for office. North Korea is in no way strategic to US interests, but he wants to blow it up -- primarily to distract the public from, and generate cover for, his disaster of a presidency, unfolding day by sad day.

I cannot say that I long for Mr. Reagan -- but I can say this man is orders of magnitude more malevolent, and inept.

Just the same, I am buoyed by optimism. . . personally. And, 11 years earlier -- do go see the google doodle this morning -- for a 1973 milestone, on this day in history -- and do watch the sharp animation. I'm out, on a sunny Friday!

नमस्ते

Thursday, August 10, 2017

Unfortunate Adult Hep B Vaccine News Update: GSK Now Out Of Commission, Too...


A bit ago, we mentioned that Merck would be stocked out on adult Hep B vaccine, for quite a while. We even speculated that the "Not Petya" hack (locking out critical systems for monitoring batch integrity, entirely) may have been part of the problem, for Merck. But at the time, US CDC was advising that Glaxo could cover the shortfall.

No more. This is disconcerting -- but to be expected, in biologics -- as I've often said, producing a vaccine in quantity -- is not unlike baking a perfect souffle -- light and airy -- but the size of. . . Wyoming. In sum it is very difficult bio-chemistry. That is why CDC always wants two independent sources. But at the moment (per FiercePharma's Manufacturing beat), both are unable to deliver viable, good vaccine stock out of the end of the pipe. GSK's operation is in Belguim; Merck's is in Durham, North Carolina and Westpoint, if memory serves. Continents apart, but both are stocked out.

Here's a bit, but do go read it all:

. . . .While GSK has been able to cover for shortages in the past, a spokeswoman said the company is currently dealing with manufacturing issues of its own.

“GSK has a global shortage of hepatitis A, hepatitis B and combination hepatitis A and B vaccines. This is due to reduced manufacturing capacity for hepatitis A and B antigens, which we are working hard to return to normal supply,” the company said in an emailed statement.

The drugmaker said vaccines are produced at a plant in Belgium but wouldn't say specifically what has caused the manufacturing bottleneck. . . .


This is, in truth, an unfortunate piece of news. And not likely to be fully resolved, before mid-2018. But as ever, onward, just the same. . . we have much for which to be thankful. Now. . . you know.

नमस्ते

Wednesday, August 9, 2017

Okay -- So This May Take A Minute... Smile.


I still think a settlement is in the offing, if for no reason other than it is costing German Merck over $2 million every six months, or over $4 million a year, just to comply with document production requests, in the US. [Background here.]

But as this contentious 11 page letter (jointly filed yesterday, at the New Jersey District Court's PACER window) -- outlining both sides' positions -- indicates, the document delivery portion of the discovery process alone may drag into next year. And US Merck rightly, I think, argues that this gives the German Merck an unfair advantage in other courts, around the globe. Courts where the US Merck is being sued, and must itself turn over all its responsive documents.

In any event, this is a nice long period, well into 2018 -- during which the two sides' lawyers will be in nearly daily contact, and settlement discussions, and agreement drafting could be occurring (in secret) on a parallel time-track. We shall see -- but now I don't expect a Q4 2017 agreed settlement, in light of this turgid letter:

. . . .Defendant has gone to extraordinary lengths to complete its production of documents, but has been unable to meet the current deadline given (1) the hundreds of thousands of documents that Defendant must review to respond to Plaintiffs’ very broad document requests, and (2) the onerous special procedures and requirements which Defendant must observe to comply with its obligations under EU data protection laws. Defendant has engaged over one hundred document reviewers in Europe (plus additional project managers) to complete the review and, as required by EU data protection laws, to redact all personally identifiable information. Unlike reviewing only for responsiveness and potential privilege issues, each reviewer must carefully review every word of every document to identify personal data and then apply the redactions. The process is so timeconsuming that, on average, a single reviewer redacts only 6-8 documents per hour (which was confirmed by a member of the U.S. legal team who flew to Germany to personally perform redactions to better understand the process and the reasons it moves so slowly). Defendant has already expended over $2 million in costs on the review and redactions, a figure likely to double -- if not triple -- before production is complete. . . .

EU data protection laws require that all of these documents be painstakingly reviewed and redacted to remove all personally identifiable information. There is a limited exception for the personal data of certain individuals, such as the custodians, but even in those cases the documents generally contain names or other personally identifiable information of other individuals that must be redacted. This procedure is set out in the Protective Order, negotiated by the parties and entered by the Court on March 6, 2017. See dkt. entry no. 66. Counsel has met and conferred extensively about the challenges imposed by the EU data protection laws and possible solutions. For example, Defendant has offered to produce the documents in un-redacted form for review in Europe by lawyers in Plaintiffs’ counsel’s European offices. Such a solution would save Defendant millions of dollars and would shave several months off the requested extension. But, unfortunately, the parties have been unable to agree on mutually acceptable parameters for this proposal or others that have been explored. . . .


Now you know -- and I can only imagine how exacting. . . those (cough!) German reviewers are being in the faithful discharge of their duties. [That is intended as a cultural compliment, not an insult, BTW.]

And, I am smiling just the same -- onward, as an eclipse celebration with my now-grown young ones, and their significant others, along with a road trip gets well organized, here. . . beaming, toward the 21st, in fact, and points southerly. . . .

unf

Tuesday, August 8, 2017

This City Of Big Shoulders Will Not Cower Before A Small Minded Tyrant...


[As an opening editorial note, we won't formally know -- until around 11:30 this morning, local in Chicago, that sweet glowing twisty lil' Cassini has turned to call home, after ring plunge number 17 (perilously close to Saturn's friction-inducing atmosphere) -- but I wanted to get the Statue of Liberty inscription back up, on the masthead, given the topic below. Improved graphic shortly, at right -- as well. Working on it, now. And a housekeeping note -- starting with next ring plunge -- No. 18 -- we will "count-down": that will be final 4; 19 will be final 3 and so on -- weekly, to September 15, 2017 (plunge no. 22) and. . . vaporization. Now you know.]

I am up early this morning to provide a full 46 page PDF copy of our fair city's lawsuit against the Trump administration's abusively unconstitutional attempts to bludgeon our city into revoking her sanctuary city status.

We are a big shouldered city, one with generally wide open minds. We believe in the fundamental dignity of all human beings, regardless of the papers in their pockets (or the lack thereof). We believe that our communities are made richer both spiritually, and economically, by including all people of good will we encounter here, in this improbable dream we call. . . America [H/T BHO 44]. And so, we will stand shoulder to shoulder, with all our brothers and sisters -- regardless of documents (so long as they are and remain tax-paying, productive and contributing members of our communities), to resist 45's hateful targeting -- singling out, really -- of Chicago. Do read it all (a 46 page PDF file) -- and a bit:

. . . .Chicago is one of America’s great cities, a metropolis of almost 3 million people that has attracted migrants and immigrants of different races, nationalities, and creeds to the shores of Lake Michigan for nearly two centuries, seeking good jobs and better futures for themselves and their children. . . .

Since the 1980s, the City has directed its police officers to prioritize local law enforcement and public safety rather than diverting time, attention, and resources to investigating residents’ immigration status. Now codified as the Welcoming City Ordinance, this policy promotes public safety by ensuring that no city resident or visitor, regardless of immigration status, is afraid to cooperate with law enforcement, report criminal activity to the police, testify as a witness in court, or seek help as a victim of crime; and by ensuring that police officers focus on criminal activity occurring in Chicago instead of federal civil immigration infractions. The Welcoming City Ordinance represents a clear, concerted, and smart policy choice in favor of inclusion and strong relations between the community and law enforcement. Chicago, its residents, and its leaders have stood behind that choice for over a generation. . . .

. . . .[45, himself, actually. . .] may not arrogate to himself the powers that our Constitution reserves to Congress, on the one hand, or to state and local governments on the other. It may not unilaterally concoct and import into the Byrne JAG program sweeping new policy conditions that were never approved (and indeed were considered and rejected) by Congress and that would federalize local jails and police stations, mandate warrantless detentions in order to investigate for federal civil infractions, sow fear in local immigrant communities, and ultimately make the people of Chicago less safe. Nor may it continue to insist that Chicago certify compliance with Section 1373 even as it withholds clear guidance about the City’s prior certifications while implying that it does not accept them, or others like them, for some ill-articulated reason. . . .

The expanded [City of Chicago] Welcoming City Ordinance provides that undocumented individuals will be detained at the federal government’s request only when Chicago has an independent reason to believe they might pose a threat to public safety: for example, if they have an outstanding [non-trivial] criminal warrant, have been convicted of a felony, are a defendant in a criminal case where judgment has not been entered and a felony charge is pending, or have been identified as a known gang member. . . .

[M]any courts have held that detaining persons for additional time solely because of an ICE detainer request is unconstitutional or otherwise unlawful. County of Santa Clara v. Trump, Nos. 17-cv-00574-WHO & 17-cv-00485-WHO, 2017 WL 1459081, at *4 (N.D. Cal. Apr. 25, 2017) (“Several courts have held that it is a violation of the Fourth Amendment for local jurisdictions to hold suspected or actual removable aliens subject to civil detainer requests because [such] requests are often not supported by an individualized determination of probable cause that a crime has been committed.”); see, e.g., Morales v. Chadbourne, 793 F.3d 208, 214-218 (1st Cir. 2015); Galarza v. Szalczyk, 745 F.3d 634, 643-645 (3d Cir. 2014). . . .


Confession: I had a very small hand in some of the above-quoted language. . . and so, I naturally endorse the filing of this federal lawsuit. I for one will not simply sit idly by, and watch Mr. Trump (vainly and largely impotently) try to rip our city asunder, by pitting us, one against another. No, I too believe in the audacious, hopeful dream that is. . . America. Thank you Mr. Mayor; and thank you, Mr. Obama before him: we in Chicago are better than this -- we are better than 45's mindless demonizing of any one group of "others".

Now, it happens that Mr. Trump's mother was an unlawful immigrant. I do not care. It also happens that (under his latest "50 per cent reduction" nonsense) 45's own father would not have been eligible to enter America, at Ellis Island. Again of itself, about this fact, I do not care.

While the irony there is delicious -- it is paramount to recognize that Mr. Trump's view of America is not even consistent with the entirely unearned benefits of a citizenship he now claims for himself -- and a few others, alone.

It is always thus with small handed (and small minded) tyrants. Resist. Resist. Resist.

Me? I am soaring this morning, after a wonderful evening in our fine city, at a roof-top bar, and then later at the Gage, with my grown son and his smart as a whip significant other. What a great time to be alive -- in one of the greatest cities on Earth! Now. . . onward!

UPDATE: Rather tardy with this, but here is the Friday filing of the fine reply brief of the State of Hawaii, in the continuing defeat of Muslim Ban 2.0, in the Ninth Circuit.

नमस्ते

Monday, August 7, 2017

FDA Issues Stern Warning Letter -- To Darwin Life -- On "Three Parent" Human Genetic Engineering Of Embryos...


It was certain to be "top of mind", in Silver Spring, Maryland -- given last week's startling news on the possibility of human embryo DNA corrections/manipulation front -- of last week. But to be clear -- that was entirely academic (in vitro) research. No implantation (en vivo) was ever going to be attempted.

Now the US FDA (quite rightly, in my view) has made sure that the (self-described) "envelope pushers" out there (i.e., not the ethical scientists in the Journal of Nature linked article) are warned: "Don't get out ahead of your regulator." And do not assume that just moving the actual implantation operation, down to a med-spa located in Mexico will solve your FDA problems. [I am putting aside my own ethical qualms here, and those of many careful biological scientists around the world (for the moment), to focus exclusively on the US legal ramifications of such manipulation -- in this post.]

This practice is simply unlawful. And it has been, for quite a while. And it should remain so. [Didn't this joker see. . . "Jurassic Park"? Dr. Ian Malcolm (played by Jeff Goldblum)remains right here -- about "can" doesn't mean "should".] Here's the PDF file -- and a bit -- of the FDA warning letter -- just issued:

. . . .Please be advised that you are using MRT to form a genetically modified embryo, which is subject to FDA’s regulations with respect to human cells, tissues, or cellular or tissue based products (HCT/Ps) under 21 CFR Part 1271, issued under authority of section 361 of the Public Health Service Act (PHS Act [42 U.S.C. 264]). HCT/Ps that do not meet all of the criteria in 21 CFR 1271.10(a) and do not qualify for any exceptions in section 1271.15, are subject to additional regulation, including appropriate premarket review.

The genetically modified embryo that you formed using MRT does not meet all the criteria in 21 CFR 1271.10(a) and does not qualify for any exceptions. Therefore the HCT/P is not regulated solely under section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264] and the regulations in 21 CFR Part 1271, but is also regulated as a drug as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)], and a biological product as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i). Specifically, your processing constitutes more than minimal manipulation of cells or nonstructural tissues, as defined in 21 CFR 1271(f)(2).

To lawfully market a drug that is also a biologic, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a demonstration of safety, purity, and potency. While in the development stage, such biological drugs may be distributed for clinical use in humans only if the sponsor has an IND application in effect as specified by FDA regulations (21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312). The MRT-produced HCT/P is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. . . .

We request that you notify this office, in writing, of the steps you have taken or will take to address the violation noted above and to prevent recurrence. . . .


Now you know. Onward, into that brave new world. . . grinning widely, just the same. Dinner in the Loop ahead tonight, with my youngest son, and his new female fellow tri-athlete friend -- visiting for a few days. . . . grin-worthy, indeed. . . . keep it spinning in natural Good Karma, one and all!

नमस्ते

[U] Continuing Carnage Dept.: Of Mr. Shkreli's 2015 Frauds, On KaloBios -- Now Called Humanigen...


UPDATED: 4:30 PM EDT -- The company has just now been granted a TRO! Next hearing against Savant occurs August 17, 2017 -- to consider a preliminary injunction. Woot! [End, updated portion.]

This morning, the company Mr. Shkreli helmed for only about 42 days -- before being arrested -- is changing its name. That is in no small part to further distance itself from. . . the stain of his name.

Along with the new name and ticker this morning, we will refresh our coverage of this now recovering public company. For his part, Mr. Shkreli's a convicted felon now, and will likely be sentenced around Christmas, of this year. Poetically perfect, that. Just about two years after he was arrested, and this company was forced to declare bankruptcy as a result of his then accelerating fraud schemes.

But today's news (almost completely ignored by the "regular" media, save one small West Coast behind pay-walls story) is that KaloBios/Humanigen has had to go seek an emergency TRO against Savant (its partner in the Chagas program), over the latter's failure to pay its share of the cost overruns, on the Chagas development project. The cost overruns are due, in Humanigen's view, to the fact that Savant did not have all the rights it needed to develop the project, when it signed with the then Shkreli-led company -- something Savant represented and warranted last year -- in the bankruptcy proceedings. Something any competent CEO (i.e., one other than Mr. Shkreli) would have been able to discern with due diligence. But now, almost two years later, it is the subject of a TRO motion in federal bankruptcy court in Delaware.

Here's a bit from the company's TRO brief (30 page PDF filed Friday, in Delaware):

. . . .Savant had represented that the assets it was selling were all that was needed to develop benznidazole for regulatory approval. Savant also agreed to assume responsibility for costs incurred in the development effort that exceeded the parties’ agreed-upon $8 million joint development budget by more thanr $500,000. KaloBios has made great strides over the last year in developing benznidazole for regulatory approval, in spite of the fact that Savant’s representations about the adequacy of its assets were not accurate. In doing so, KaloBios has incurred costs that Savant is obligated by contract to pay, an obligation Savant has refused to honor.

Instead, Savant has unleashed a campaign of harassment against KaloBios, manufacturing defaults and threatening to seize KaloBios’ assets. Late on the night of August 2, 2017, Savant made good on its threats by issuing a foreclosure notice, stating that, on August 9, 2017, KaloBios is to assemble and present to Savant for seizure the materials, contracts, inventory, records and information necessary to develop and commercialize benznidazole, and informing KaloBios that it intends to auction those assets at a public auction on September 1, 2017. . . .


To be fair, here is Savant's counterclaim filing, in the same suit -- and Savant's Monday morning brief in response to the motion for a TRO. It has reached a full-rolling boiling point, in Delaware federal bankruptcy court -- starting in an hour -- by telephonic hearing.

Stay tuned -- we will update you, here. [Postings here and on the other properties may be intermittent -- as I have a series of leisure trips scheduled for mid-August to late September. . . . Smile.] Updated: Fixed the link to TRO brief -- H/T to PathoPhilia!

नमस्ते

Friday, August 4, 2017

[U] Martin Shkreli: Convicted Felon. My Bet Is The Sentence Is Ten Years.


More soon. A quiz from this morning -- by Billy The Kid -- to pass the time in the media room. . . . UPDATE: Emily Saul just reported by tweet, that the jury got started almost a half hour earlier than normal, even with rain delaying other commuters. I think that means they want to wrap up by end of day, for certain. They stayed late both two days ago, and yesterday -- by about 20 minutes each.

Now they are in early on a Friday morning. Seems like today will be the day. [End update.]

POST VERDICT: He was never going to beat Count 8 -- I said it a million times. They had him dead to rights.

I won't unduly belabor it -- there is plenty here to give him more than ten -- but Judge Matsumoto will say truthfully he has no prior violent offenses.

He was astonishingly flagrant -- in his violation of the law, under Count 8 -- so I predict he gets ten for that one alone.

They say you can tell when justice has been done: "justice... they say, is when everyone feels just a little uncomfortable." I think that is apt at the moment, all the way around.

By the way -- Mr. Shkreli just had his ass handed to him, by the GIRLS' [Grrrrl POWER!] Junior Varsity. Hilarious -- in. his. own. words.

There is much more at the other property -- especially in the now thousands of comments in the comment boxes, there. Off the grid again now. Smile. . . . Keep it spinning in good karma, one and all. . . . Oh, and. . . Here is my completed Quiz, as a full color hand written PDF, from this morning! Hah!

नमस्ते

Thursday, August 3, 2017

The Final Legal Bill Is In -- On Merck's Ex-Internal Counsel's Misconduct, In USDC ND CA Case with Gilead...


And (as I guessed, exactly one year ago) it did end up a little under $14.3 million. But no one will be paying that amount any time soon, as Merck will soon file an appeal on the fee award, in addition to its overall appeal, in California.

In an overnight order, the able Judge Labson-Freeman has -- by agreement of all parties -- held that Merck need not file a bond while this particular appeal is pending (of course the company can afford to pay the fees, many times over). Here is the operative part, but do also see my observation below the order -- Merck itself is in fact likely owed many times this amount, FROM Gilead -- in Delaware.

. . . .Accordingly, the parties stipulate and agree that the Court should order that the total amount of attorney fees to which Gilead is entitled is $14,298,581.53.

STAYING ENFORCEMENT OF AWARDS OF COSTS AND FEES WITHOUT BOND

The due date for a notice of appeal with respect to the Court’s order quantifying the amount of fees, D.I. 489, is August 14, 2017. Merck anticipates filing a notice of appeal by that date with respect to (1) the order quantifying fees, (2) the Court’s underlying order granting fees, D.I. 457, and (3) the Court’s order taxing costs, D.I. 490. Merck previously appealed from the Court’s judgment and its underlying Order Regarding Non-Jury Legal Issues. See D.I. 463 (Aug. 23, 2016). . . .

Because Merck has agreed to take responsibility for any awards of costs and fees remaining after all appeals in the case are resolved and final and further because there is no question as to Merck’s ability to pay the awards of costs and fees, the parties further stipulate and agree that the posting of a supersedeas bond is not necessary to secure Gilead’s rights pending appeal and that the expense required to post the bond would be wasteful under the circumstances. . . .

Accordingly, the parties stipulate and agree that the Court should exercise its discretion and find that no bond is necessary to secure the judgment, and order that any execution or enforcement of the awards of costs and fees be stayed without Merck having posted a supersedeas bond. . .


I might also add that Gilead is now in post-trial motion practice, in the Delaware federal District Courts, against Merck -- on a $2.54 billion (yes with a "b") judgment in FAVOR of Merck, and against Gilead -- which is highly likely to be reduced, but likely means that net, net -- Gilead will actually be paying Merck a net amount -- i.e., not ultimately receiving this $14.3 million in fees incurred, in the West Coast litigation -- on many of the same compounds, topics and discoveries -- as the Delaware ones. Now you know.

नमस्ते

[U] A Small -- But Very Long Term -- Problem: Of The Identity Of A Fortune 30 Company...


UPDATED @ 10:30 AM EDT -- August 3, 2017: The incorrect image at right has been replaced with an image depicting US Merck facilities (and although I don't really care, the image is now of Merck's old HQ -- at Whitehouse Station -- not Kenilworth, the current HQ -- as the image blub would suggest). Still. . . each of the points below merits some sober consideration, from decision-makers -- at both companies. [End update.]

Overnight, I've had a chain of very cordial, pleasant email conversations with the very able editor, and writer, of the piece imaged at right. [Important background here.]

It gets all the written details exactly correct. But it blasts a graphic that overwhelms everything -- and sullies the good name of another pharma-chem company. An entirely unrelated one -- one frankly both smaller, and struggling in a way our US Merck is not. In sum, this article implies (completely inaccurately) more materially negative news about the German Merck. All because the graphics people were slipshod -- in their review.

To be fair to Ms. Davis, here -- both of these companies ought to put an end to this confusing nonsense. It hurts BOTH of their brands. And it is completely. . . avoidable. We have been talking about this since 2010 (and the "troubles", they have been on and off since 1919, but much more often "on" -- since 2007), Consider this old post, as but one example::

. . . .Peter Sinnott

So when will the real Merck get the url back?

Yesterday at 11:26am · Likes · 10. . . .

James Hooker

As I understand it, either the two companies must come to some sort of agreement over the URL (one takes ownership, or shared ownership?) or Facebook will prevent the 'Merck' vanity URL from being used at all, forcing each company to create a new URL based on their specific company name (MerckKGaA/MerckCo as examples).

6 hours ago · Likes · 1. . . .

James Hooker

Quite ludicrous in my opinion, seeing as the error was Facebook's, and that the vanity URL was originally registered by the German company.

6 hours ago · Likes · 1. . . .

James Hooker

‎. . . .also, regarding the fault being placed on Facebook, surely you KNEW the page you requested access to did not belong to your company?

5 hours ago · Likes · 1. . . .


Just silly -- ridiculous that both companies' public shareholders tolerate this sort of avoidable damage, to their respectively generally very good names.

[Segue. . . .] Now, in keeping with my new (contra-intended) masthead -- I must remark that 45's notion of acceptable immigration numbers, and preferred college admissions -- now seem to skew toward. . . whiteness. And likely mostly undeserving whiteness -- in an appeal to the most primitive aspects of his base's nature.

On the lawful immigration front, he would exclude grandparents, as family, and low wage workers, preferring instead to take the jobs (to the extent that ever even really happens) from higher income positions. . . all while now looking into whether there is not ALREADY enough white privilege embedded into the college admission process. It is true that high-scoring Asian-Americans, not white Americans (in the main) are the ones most "disadvantaged" (to the arguable extent that anyone can say they are disadvantaged by the current aspirational diversity goals, in college admissions), i.e., under the current system.

Once again, the primitive in chief traffics in hate as opposed to logic. Me? I think we sons and daghters of immigrants -- I think we "get the job done!" Credit Emma Lazarus (as quoted on the base of the Statue of Liberty) -- and Lin-Manuel Miranda, lyrics to "Hamilton", there.

नमस्ते

Wednesday, August 2, 2017

A Short Story: From Long, Long Ago, In A Galaxy Far, Far Away...


I will be off grid today, on another deal -- so I'll leave you with this:

Over the past few weeks (and largely unnoticed), I have been quietly trading comments with an anonymous commenter, also with loads of real world experience -- about a 1990s era deal -- or six. Smile. We've been chatting -- via very, very old posts made here. Deep in the library's archives stacks, as it were. Smile. If you are at all interested or curious, just search KBI and read the posts in commentary.

For now, though -- know that when I first picked up the phone, after disconnecting the dial-up -- almost 19 years ago -- this (at right) Boulder, Colorado deal was occupying a fair bit of my daily life. The notion of an oxygen transporting substitute for human blood was a very alluring goal, then. But, as with many attempts, it was what we learned -- from its failure, that lasted most. . . . it seemed that slightly more trauma patients in remote locations (where no transfusion was available) died after receiving it, as opposed to no treatment. Fascinating -- and so it goes. Onward.

It seems some times, the best course of action. . . is no action, at all.

नमस्ते

Tuesday, August 1, 2017

Mr. Trump's Hate-Filled Rhetoric Leads To... Bi-Partisan Efforts To Shore Up ObamaCare 2.0.


While 45 wastes his twitter-rage on threatening the Senate, if they don't resume his thrice-failed repeal attempts. . .

Both GOP and Democratic Senators are working resolutely, and quietly, together -- to shore up the insurance markets, under ObamaCare. Those same markets 45 is trying mightily to make implode. Below is a bit from tonight's New York Times -- but this is exactly what I hoped for: Trump is going to get almost the polar opposite of what he tried to bully his way into.

. . . .Senator Lamar Alexander of Tennessee, the influential chairman of the Senate Health, Education, Labor and Pensions Committee, announced that his panel would begin work in early September on legislation to “stabilize and strengthen the individual health insurance market” for 2018. He publicly urged Mr. Trump to continue making payments to health insurance companies to reimburse them for reducing the out-of-pocket medical expenses of low-income people.

In the House, two Republicans, Representatives Tom Reed of New York and Charlie Dent of Pennsylvania, teamed with Democrats to promote incremental health legislation that would also fund the cost-sharing subsidies.

The moves were a remarkable response to the president’s repeated threats to send health insurance markets into a tailspin. They offered tangible indications of cooperation between the parties after Republican efforts to scrap the Affordable Care Act collapsed in the Senate last week, all but ending the seven-year Republican quest to overturn President Barack Obama’s signature domestic achievement. Lawmakers from both parties concede that the health law needs improvement, as consumers face sharp premium increases and a shrinking number of insurance options in many states.

These problems have been exacerbated by a president who has publicly predicted that the Affordable Care Act will “implode” and appears determined to help fulfill that prophecy. Mr. Trump has repeatedly threatened to cut off the subsidies, known as cost-sharing reduction payments, which reimburse insurers for cutting deductibles and other out-of-pocket costs for millions of low-income people. Without them, insurers would almost certainly raise premiums not only for poor consumers but also for many other people buying plans on the individual insurance market. . . .


So, the ACA of 2010 will move forward, and onward. And Mr. Trump's efforts to kill it will. . . fail. G'night all. Off grid, essentially all day tomorrow.

नमस्ते