This is as perfect as it gets:
DO watch both — repeatedly.
Category: Uncategorized
FDA Breakthrough Designation; EMA “PRIME” Designation — For Merck/NewLink V920 Ebola Vaccine Candidate
We must remark once again just how hard it is — to overstate the importance of this vaccine candidate — in arresting the last Ebola epidemic, in Africa. The so-called V920 rVSV∆G-ZEBOV-GP vaccine has thus far proven 100 per cent effective, when deployed in a ring fashion, against the virus in people who’ve come in close contact with an active Ebola carrier.
So it makes sense that both the European Medicines Agency, and the US FDA would put the candidate on a fast track to approval. And that’s just what both have done, as of this morning. While Kenilworth certainly deserves generous plaudits for its work in both finishing the R&D, and actually mass-producing the vaccine — and getting it intact and active, into the very difficult geographic environment Africa presents — we should not forget the ten years plus worth of solid work of Canadian Public Health Agency scientists, and the NewLink Genetics team. Here’s a bit from the story, out of Ames, Iowa this morning — do go read it all:
…Merck, known as MSD outside the United States and Canada, [along with Ames, Iowa-based NewLinks Genetics] has reached two key regulatory milestones for the Ebola Zaire vaccine candidate known as V920 (rVSV∆G-ZEBOV-GP). The U.S Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has provided the vaccine candidate PRIME (PRIority MEdicines) status.
V920 was initially engineered by scientists from the Public Health Agency of Canada and subsequently licensed to NewLink Genetics. In late 2014, when the peak of the Ebola outbreak in western Africa was at its worst, NewLink Genetics licensed V920 to Merck, with the goal of accelerating the development, regulatory approval, and availability of this candidate vaccine. Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920. Since that time, Merck continues to work closely with NewLink Genetics and their external collaborators to accelerate development and licensure.
“These regulatory designations reflect great credit upon the extraordinary public-private partnerships which have allowed the vaccine candidate to be included in 12 Phase 1, 2 and 3 studies on three continents in less than two years,” said Thomas P. Monath, M.D., Chief Scientific Officer and Chief Operating Officer of the Infectious Disease Division of NewLink Genetics. Charles L. Link, Jr., M.D., Chairman, Chief Executive Officer and Chief Scientific Officer of NewLink Genetics emphasized that, “While the Ebola Public Health Emergency of International Concern (PHEIC) is over, we know the threat of re-emergence remains. We are encouraged by these FDA and EMA decisions which we hope will aid progress of the candidate vaccine towards potential licensure….”
And bit by bit, the world’s bio-science community is putting the WHO in a position to much more quickly arrest future outbreaks. Sadly, it is an inescapable fact of biology that the virus will eventually reappear — but it need not become an epidemic, the next time around. Smiling widely — on a clear mid-summer Monday morning, now — brimming with optimism on my walk in, here. Be excellent to one another.
Now, With Time To Reflect — On Mr. Trump’s Final Convention Speeches…
The below is not a particularly new thought. But it was forcefully made, by Mr. Trump himself, on Thursday evening. [Art work, at right, linked to artist, here.]
Mr. Trump’s chosen introduction speaker, his daughter, spoke at length about new social programs (childcare, etc.) — programs that Republicans have grown fond of calling “socialism”. Fair enough. Let’s accept their nomenclature, at face value.
Mr. Trump’s own speech — given even in the style of the speaker I am about to invoke — uniformly bellicose, overbearingly loud and monotone it its unrelenting fire — was almost all about NATIONALISM.
Anti-immigrant, anti-free trade, religious testing, and very much about police powers, as opposed to individual liberties — yes, this is nationalist rhetoric.
So — the unmistakable — and correct, impression of Mr. Trump’s remaking of the GOP’s platforms must be seen as… a return to the rhetoric of national socialism.
Yes, Mr. Trump — that was the what the Third Reich called its party platform — national socialism. I won’t get too terribly hung up on using labels as crutches — but calling your brand of politics Nazi-ism is not inaccurate, Mr. Trump. It is exactly what you espouse. And your speechifying sounds positively Hilter-ian, to my ear.
But do march forward, with your goose-stepping brown-shirts — who threatened the WIFE of a sitting US Senator (from Texas, not that he is anyone’s innocent), on the convention floor, after her husband, and a member of your own party — had the temerity to urge people to “vote their conscience” this fall. Yes it all surely looks sadly… familiar.
Mr. Hinderaker Is Quite Lucky That Mr. Obama Is A Public Figure…
It is quite clear that Mr. Hinderaker understands the effectively broad license — to libel and slander — in America.
He clearly understands that, when he is speaking about a matter of substantial public concern, and speaking about an elected official, as a public figure, in his elected capacity — it is nearly impossible to lose a libel suit.
This is so, because as contemplated by our system of robust liberties — as to political speech — we as a people favor vigorous, wide and even falsely-premised and ill-founded debate. We encourage more speech, as the remedy for false speech, of this sort.
So… Mr. Obama would have to show that Mr. Hinderaker was both (1) aware that what he wrote was patently untrue, and (2) that he wrote it with intent to harm the President. Or he would have to show that Mr. Hinderaker did it with “reckless disregard for the truth or falsity” of the statement at issue.
That is one tall order — but Mr. Hinderaker is within an eyelash of violating it, here (especially as to the second class of libel plaintiffs, below):
“…Ten years ago, there was not a movement dedicated to attacking, and sometimes killing, police officers – worse, a movement supported by the President of the United States himself….”
He intentionally, and misleadingly, links Mr. Obama’s statements of understanding about BLM’s goals — NONE of which are the killing of police, BTW — to the killing of police, by NON-BLM affiliated rogue sociopaths and miscreants. In most courts around the rest of the world, that would be libel, per se.
It may not be libel per se as to our President here in the USA (due to the above), but it may well be libel per se, as to the people of BLM — the website, and officials of which have never called for killings of police officers.
I may just… make some calls. Stay tuned. There may be real clients out there — and they may wish to have their damages taken from Mr. Hinderaker’s quite substantial net worth, and contributed to increasing BLM’s reach.
Congrats, Mr. Hinderaker — you may end up as BLM’s biggest 2016 cash contributor! Sweet irony.
Y A W N. Trump Will Definitely Lose.
Yes — I can easily admit it: he probably delivered the best speech of his life tonight.
And still he failed to attract any new demographics, in all likelihood. And he is still losing in the six key states he must win to have any chance of winning the White House.
He may have even alienated some of his nuttiest base elements. But let’s address the central problem with most of his speech:
The American people are much smarter than he thinks they are, obviously. When he promised, preposterously, to end ISIS’s influence — and end it “fast” — well, that’s a promise all of America knows he cannot possibly keep. There were dozens of them: crime will somehow magically “end” on January 20, 2017?! His best speech was filled with promises he has zero intention of keeping. That’s exactly how he’s always run his businesses, so we should not be surprised. But this time, it won’t work.
He will lose — and this will likely turn out to have been the high water mark — of his chances for winning the White House — just under a 40 per cent chance, compared to just over a 60 per cent chance, at the moment, for Hillary Clinton.
Hillary Clinton will surge during next week’s convention coverage, and her lead will return to 80-20 probabilities. In short, she will never look back — she will beat Trump by double digits.
Now you know.
I Guess Mr. Cruz’s “Vote Your Conscience” Speech Tonight Was Missed By Mr. Hinderaker…
Well — these goofy Trumpers have turned the RNC into a WWF show, tonight. Hilarious. Trump walks in to cut off Mr. Cruz’s speech? The TV monitors cut out from time to time?
Mr. Christie, in remarks to TV reporters on the floor, calls Mr. Cruz “shameful,” and “not a man of integrity.” Gee — is this the part of night three, when the party finally unifies? Cool.
Here is John (clearly a few paragraphs behind) — he was apparently on an Australian TV interview appearance when Ted Cruz (whose wife needed a security escort to leave the arena, after his speech) echoed the #NeverTrump movement’s “vote your conscience” mantra — and pointedly REFUSED to endorse the currently proposed ticket. Take it away, Mr. Hinderaker:
…I don’t know whether any conclusions can be drawn from the failure of widely-predicted anti-Trump activity to materialize, but I do think the relatively boring march to the nomination that we are seeing in Cleveland is good for Trump and for the party….
I don’t really think threatening a sitting US Senator’s wife qualifies as “good for the party and Trump”. But what might I know? It couldn’t happen to a nicer bunch of folks, truly.
Onward — into the abyss, which is a Trump-Pence landslide loss — with Mr. Cruz starting his obviously self-aggrandizing 2020 GOP Presidential nomination run… tonight.
If there is still a GOP by 2020 — in name or otherwise, that is.
Not Falling For Mr. Hinderaker’s Subject Changing Nonsense…
Rather than (once again!) showing Mr. Hinderaker his “fallacy of composition” errors — in his own hopelessly flawed “analysis” of old DOJ uniform crime reports (and his race-baiting, long debunked theories based on the same), I think it far more useful, tonight, to report what our President has written and said, to the nation’s law enforcement officers, overnight:
“…As we bind up our wounds, we must come together to ensure that those who try to divide us do not succeed. We are at our best when we recognize our common humanity, set an example for our children of trust and responsibility, and honor the sacrifices of our bravest by coming together to be better.
“Thank you for your courageous service. We have your backs….”
Actually I DID NOT “Prefer It”* — In The “Stolen” German/Slovenian…
Once again, rather than movng on, and acknowledging their (and his) fault — Mr. Hinderaker doubles down on the lying lunacy, at midday, on Day Two of the GOP convention. He offers the headline “Plagiarism? Please!” — but then goes on to… admit it happened. Nutty. Here’s the bit that was most openly laughable, in my opinion:
“…I suspect that one of Melania Trump’s principal objectives in her speech was to draw that contrast between herself and Mr. and Mrs. Obama….”
Uh-huh. And she did so (I gather, in John’s wildly off-kilter world-view), by parroting Mrs. Obama’s exact turns of phrase, for a few paragraphs, John? R-i-i-i-i-ight. At least Mr. Hinderaker admits the “Team Trump” is — by all accounts — simply the gang that can’t shoot straight — even in the smallest of endeavors:
“…For now, at least, it seems that the Democrats have successfully negated Melania Trump’s strong performance last night. We probably shouldn’t be surprised: it wouldn’t be the Trump campaign, after all, if a stupid, self-imposed distraction didn’t cancel out a lot of good work….”
Except for the fact that all “the Democrats” did was read MSM reporting to the effect that the speech was lifted, in significant part — I guess… I can agree. But this is NOT a team I’d trust with nuclear weaponry.
I’m jus’ sayin’….
~~~~~~~~~~~~~~~~~~~~~~~~~
* My post title is a derivative of the old bon mot: “Actually, I preferred it in the orginal German…” [Google that, if you are too young to remember.] Hint: it was the immortal Art Buchwald, on one of Pat Buchanan’s speeches — in the middle 1980s.
Her “Exotic Quality”?! Oh, Mr. Hinderaker… UPDATE: That “Quality” Was Stolen, To Boot.
I am worried that John is losing his grip on 21st Century reality. He first praises Mr. Trump’s spouse — not for her thoughts, but her “exotic quality“. After all, for John, it matters not what she’s saying, but how she looks, saying it.
On reflection, it may have been just dumb luck — in picking his remarks, in that order — since (had he talked substance, over appearances) Mr. Hinderaker would have been praising the thoughts of another “exotic” lady, had he praised “her” thoughts.
A FIRST Lady, in fact: Michelle Obama. Mrs. Trump (or her ghost-writer) simply stole a few paragraphs, from Mrs. Obama’s 2008 speech, it now seems quite clear. How exquisitely ironic — her most personal thoughts, and about family values, no less — are actually those of our 44th President’s family by marriage. That’s wickedly ironic.
But let’s return to John — and presume that he wrote this before the world knew she stole her best lines — or her ghost-writer did. [It is fitting that that some of the stolen lines are about keeping one’s word.]
Here is his, in context:
…Melania’s exotic quality and the fact that we have not previously heard much from her commanded attention. I think that in the eyes of most viewers, she gave Donald a real boost. The CNN commentators thought so too, with Anderson Cooper in awe and a couple of Clinton operatives trying desperately to find a negative, or at least neutral, spin.
The conventional wisdom is that a vice-presidential candidate rarely has any impact on an election. A candidate’s spouse, presumably, has much less. But we haven’t seen the last of Melania Trump. As I said, I think a star was born tonight, and we will see much more of her between now and November. Unless I am badly off the mark, she will be very popular, and not just with Republicans….
Actually John, that star’s speech was born in 2008. And… her name is… Michelle Obama. She’s your FLOTUS.
Mr. and Mrs. Trump will now proceed to lose — in a landslide. It is all but certain now. And Mr. Hinderaker’s recurrent inability to see past a woman’s looks (or less charitably, to see women with anything other than his Johnson) has been made plain: he’s over the hill — a decrepit relic, from the last Millennium. Bub-bye John.
Mr. Hinderaker Thinks Not Getting Caught In A Lie…
…Is the same thing as having told the full truth.
It is decidedly not.
Mr. Hinderaker has long pedaled the lie that Mr. Obama’s telling the truth about the difficulties of race relations in America makes him responsible for the deaths of policemen. It is so white of Mr. Hinderaker to blame the messenger, when he gets itchy about the message. [It shouldn’t need to be repeated, but I will: Mr. Obama has never called for violence — quite the opposite.]
Mr. Hinderaker has long believed that (as has long been the GOP’s openly stated policy, since the Southern Stragegy of the early 1960s) it is an elected official’s duty to tell lies aboout race relations, in particular, in order to secure his own personal dominant position, his false comfort and ultimately safety (based on that lie). White America’s comfort with itself, to be more precise.
Mr. Hinderaker told this lie again yesterday, further politicizing the murders, by a lone and seemingly deranged ex-Marine, of three officers in Baton Rouge (and three more wounded). He tells us that these officers’ murders are Mr. Obama’s “fault” — (in some completeely unarticulated mysterious way) — I gather because Mr. Obama told all of America an uncomfortable truth about itself.
I can’t get there.
But Mr. Hinderaker has been lying to his audience since he opened that blog, and so it is his second nature — to tell the lie that people who make him uncomfortable about his whiteness, are responsible for all manner of awful crimes.
Heaven forbid that he be willing to address the root cause of these crimes.
But that would entail his admitting that he was never the Master of the Universe he imagined.
His ego will never allow him to do it. Never.
But Mr. Obama is right: we have a problem — and only with talk, not guns — will be begin to address it.
