On Jan. 6, did highest-level US military officers willfully disobey Commander in Chief?

 Even the January 6 committee eventually conceded that President Trump had authorized the National Guard to be deployed on January 6. However, as events unfolded at the Capitol, the National Guard was nowhere to be seen. It showed up hours later, only after the situation was such that Trump and his supporters were tarred as “insurrectionists” and targeted for arrests. Now, a whistleblower has come forward to allege that one of Trump’s problems was that military leadership, starting with Mark Milley, made the deliberate decision to ignore Trump’s order. That’s court-martial stuff, along with the possibility of domestic terrorism and, ironically, insurrection.

Whenever thousands of people descend on a city, there should be a large police force in place. And when hundreds of thousands come to D.C. to complain about an election outcome, the National Guard should be there. And yet the troops weren’t. Here’s what we know.

Despite being warned about potential agitators and violence, Nancy Pelosi and D.C. Mayor Muriel Bowser refused to put the National Guard on standby. We also know that even the improperly convened, hyper-partisan, and corrupt January 6 committee acknowledged that Trump approved deploying the National Guard days before the event, greenlighting its immediate deployment in case things got out of hand.

And yet it wasn’t until well after 3 p.m. and into the 4:00 hour that the National Guard was mobilized. Troops finally showed up after 5:00. Significantly, by this time, the insurrection narrative (which could not have been organic so, therefore, must have been planned) was in place. These tweets are proof of the narrative instantly going into place:

 

 

 

It doesn’t take a genius to know that this was a set-up. And now, a whistleblower has come forward to say that the Pentagon was part of the set-up, going so far as to disobey Trump’s National Guard authorization for hours, enabling the narrative to be set.

According to Colonel Earl Matthews, the senior Pentagon leadership wasn’t just dragging its heels. Instead, it had put plans in place to refuse to comply with any order that President Trump, the constitutional Commander in Chief of the United States military, issued to deploy the National Guard:

But Matthews says that senior military leadership essentially stripped the president of his authority as commander-in-chief by preemptively planning to go against orders because they didn’t like the optics of uniformed soldiers at the Capitol.

‘I think a very plausible argument can be made that through no fault of his own, President Trump’s command authority over both the D.C. National Guard and the U.S. Army itself had been surreptitiously curtailed by the senior leadership of the Army on January 6, 2021,’ Matthews told DailyMail.com.

He continued: ‘Army leadership had unreasonably anticipated an ‘unlawful order’ from the President, an order that the President had no plans to issue, and were preemptively seeking to curtail his discretion to issue such an order.’

Matthews, who was the Staff Judge Advocate of the DCNG during the riot, was on the consequential and highly discussed phone call the afternoon of Jan. 6, 2021 with [former Army Secretary Ryan] McCarthy, D.C. Mayor Muriel Bowser and other senior leadership.

Matthews also said that while the Chief of Staff for Operations, Charles Flynn, had testified under oath that he was not on the call, he was, in fact, on the call, along with Army Staff Director Walter Piatt.

Both Flynn and Piatt, says Matthews, were seemingly disinterested in U.S. Capitol Police Chief Steven Sund’s pleas for reinforcements. Instead, they were worried about “the optics of the Guard coming to the Capitol.” Ironically, let me add, they were seemingly unconcerned when the Pentagon locked the Capitol area down completely upon Biden’s inauguration and long afterward. Once Trump was gone, showing Biden’s military might seemed to be the name of the game.

Matthews was not ambiguous in his take on what happened. He says that military officials deliberately and absolutely disobeyed Trump’s orders:

‘Former President Trump’s eagerness to engage the U.S. military to play a visible role in addressing domestic unrest during the late spring and summer of 2020 does appear to have prompted senior military leadership to take precautions, in preparing for the joint session against the possibility that the DC Guard might be ordered to deploy for an improper use,’ the [January 6 committee] final report reads.

But Matthews confirms the President’s authority was ignored or completely balked by Piatt and Flynn, as well as other military leaders.

And he says it is contradictory to try and blame Trump for the delay while also claiming he was attempting to use the DCNG to stop certification of the 2020 election results.

In sum, Matthews alleges that a cabal within the American military leadership planned to—and did—ignore an order from their constitutional Commander-in-Chief. They did so despite having reason to believe that doing so ran the risk of creating dangerous conditions in and around the United States Capitol, and, in fact, those dangerous conditions occurred. I’ve listed at the end of this post the sections of the Uniform Code of Military Justice that apply to their alleged conduct, including domestic terrorism and insurrection. These officers should all face a court-martial (and the retired ones can be returned to active duty) because if you want an insurrection and a coup, this was it.

Image: Colonel Earl Matthews (edited). YouTube screen grab.

Applicable provisions from

the U.S. Constitution and the United States Code

Constitution, Art. II, Section 2:

The President shall be Commander in Chief of the Army and Navy of the United States, and of the Militia of the several States, when called into the actual Service of the United States; he may require the Opinion, in writing, of the principal Officer in each of the executive Departments, upon any Subject relating to the Duties of their respective Offices...

10 U.S. Code § 881 - Art. 81. Conspiracy:

(a) Any person subject to this chapter who conspires with any other person to commit an offense under this chapter shall, if one or more of the conspirators does an act to effect the object of the conspiracy, be punished as a court-martial may direct.

(b) Any person subject to this chapter who conspires with any other person to commit an offense under the law of war, and who knowingly does an overt act to effect the object of the conspiracy, shall be punished, if death results to one or more of the victims, by death or such other punishment as a court-martial or military commission may direct, and, if death does not result to any of the victims, by such punishment, other than death, as a court-martial or military commission may direct.

10 U.S. Code § 890 - Art. 90. Willfully disobeying superior commissioned officer:

Any person subject to this chapter who willfully disobeys a lawful command of that person’s superior commissioned officer shall be punished—

(1) if the offense is committed in time of war, by death or such other punishment as a court-martial may direct; and

(2) if the offense is committed at any other time, by such punishment, other than death, as a court-martial may direct.

10 U.S. Code § 892 - Art. 92. Failure to obey order or regulation:

Any person subject to this chapter who—

(1) violates or fails to obey any lawful general order or regulation;

(2) having knowledge of any other lawful order issued by a member of the armed forces, which it is his duty to obey, fails to obey the order; or

(3) is derelict in the performance of his duties;

shall be punished as a court-martial may direct.

10 U.S. Code § 894 - Art. 94. Mutiny or sedition:

(a) Any person subject to this chapter who—

(1) with intent to usurp or override lawful military authority, refuses, in concert with any other person, to obey orders or otherwise do his duty or creates any violence or disturbance is guilty of mutiny;

(2) with intent to cause the overthrow or destruction of lawful civil authority, creates, in concert with any other person, revolt, violence, or other disturbance against that authority is guilty of sedition;

(3) fails to do his utmost to prevent and suppress a mutiny or sedition being committed in his presence, or fails to take all reasonable means to inform his superior commissioned officer or commanding officer of a mutiny or sedition which he knows or has reason to believe is taking place, is guilty of a failure to suppress or report a mutiny or sedition.

(b) A person who is found guilty of attempted mutiny, mutiny, sedition, or failure to suppress or report a mutiny or sedition shall be punished by death or such other punishment as a court-martial may direct.

10 U.S. Code § 916 - Art. 116. Riot or breach of peace:

Any person subject to this chapter who causes or participates in any riot or breach of the peace shall be punished as a court-martial may direct.

18 U.S. Code § 2381 - Treason:

Whoever, owing allegiance to the United States, levies war against them or adheres to their enemies, giving them aid and comfort within the United States or elsewhere, is guilty of treason and shall suffer death, or shall be imprisoned not less than five years and fined under this title but not less than $10,000; and shall be incapable of holding any office under the United States.

18 U.S. Code § 2383 - Rebellion or insurrection:

Whoever incites, sets on foot, assists, or engages in any rebellion or insurrection against the authority of the United States or the laws thereof, or gives aid or comfort thereto, shall be fined under this title or imprisoned not more than ten years, or both; and shall be incapable of holding any office under the United States.

18 U.S. Code § 2331 - Definitions (Terrorism):

As used in this chapter—

[snip]

(5) the term “domestic terrorism” means activities that—

(A) involve acts dangerous to human life that are a violation of the criminal laws of the United States or of any State;

(B) appear to be intended—

(i) to intimidate or coerce a civilian population;

(ii) to influence the policy of a government by intimidation or coercion; or

(iii) to affect the conduct of a government by mass destruction, assassination, or kidnapping; and

(C) occur primarily within the territorial jurisdiction of the United States...

https://www.americanthinker.com/blog/2024/05/on_january_6_did_america_s_highest_level_military_officers_willfully_disobey_their_commander_in_chief.html

At GWU, student radicals put people on trial and announce they're executing them

By Monica Showalter

While Columbia and UCLA swept out their campus protestors like bad garbage, and USC did the same this morning, George Washington University remains a haven of radical looniness.

Here's a tweet showing just what the campus communists are up to as other protests shut down:

At the George Washington University Gaza Solidarity Encampment today, the protesters held a "People's Tribunal" where they put President Ellen Granberg, Provost Christopher Bracey, the Board of Trustees, @GWPolice, and many others on trial.

Is it normal for students to want to… pic.twitter.com/M8F543q0MV

— Stu (@thestustustudio) May 3, 2024

It seems to be a mock trial, nominally about Gaza, with campus protestors declaring themselves judge and jury for all their university overseers -- the provost, the trustees, maybe their profs, who don't kowtow to their robotic party line, with lots of 'guillotine! guillotine! guillotine!' verdicts coming from these losers.

PJMedia has a more description of these half-baked Robespierre wannabes in this piece here:

I do not know if they are confusing the title of "provost" within George Washington University's faculty as the academic supervisor with a supervisor of law enforcement (like "provost marshal"), but accusing Mr. Bracey of assault just adds another element of absurdity to this "tribunal" these kids are hosting.

Right after, the girl on the megaphone proclaims, "Off to the m*****f***ing gallows with you."

But hold on, it gets stupider.

The girl on the megaphone then accuses GWU's Board of Trustees of profiteering off the "genocide" of Palestinians, and after the other students loudly proclaim them "guilty," she yells, "To the guillotine!"

Finally, they also call for GWU President Ellen Granberg and her apparently "f****** bob [haircut]" to be under the guillotine as well for "using [their] tuition dollars to fund genocide."

Stu Stu Studios also posted a longer version, but the fact that these kids are openly and publicly calling for the deaths of specific people who can very likely hear them just underscores how insane these "protests" really are.

Which rather shows you that they've got Red Guard instincts, and just not enough opportunity to act them out for real. Like Lenin and Stalin and Mao and Pol Pot and Castro and Che, they dream big of executing anyone they don't agree with, and often for childish clown-show reasons.

A lot of those evil creatures who went on to murder millions were expelled from their universities for a lot less than calling for the murder of the people who run the universities. But the states of these places, unlike the universities, were weak, so they went on to wreak revolutionary murder for real. Over here, even the universities are weak.

Maybe they shouldn't be weak, because these are mice with ambitions of being rats. They are monsters in the making. Expel them from all civilized society.

https://www.americanthinker.com/blog/2024/05/at_gwu_student_radicals_put_people_on_trial_and_announce_they_re_executing_them.html

Camp Intifada: Students for Theocratic Authoritarianism

 By Clarice Feldman

I’m old. So old that I still believe that classic Western liberalism is the best system for assuring prosperity and peace, and authoritarianism, particularly of a theocratic nature, is a disastrous governance style. Watching the encampments and riots on college campuses, I see that too many young people have missed this lesson and instead support violent, barbaric, theocratic authoritarianism. I think these participants are not representative of a majority of students or voters and that the weak responses of some universities bode ill for their futures. Moreover, I think the Administration’s failure to act on the side of Western civilization is seriously damaging President Biden’s reelection prospects, indeed, the prospects for the Democratic party itself. In the absence of a federal response, private litigation is likely to prove particularly damaging to those who have funded and encouraged or tolerated these campus outrages.

Several lawsuits are in the works. At least three have already been filed. The most significant was a suit filed in Virginia this week alleging that the National Students for Justice in Palestine coordinated with Hamas, an organization federally listed as a terrorist organization, to orchestrate these campus attacks. The suit claims that NSJP “has effectively become the campus arm of Hamas” and is “directly aiding and abetting the terror group on American colleges” and “facilitating the conditions necessary for Hamas to continue carrying out acts of terror and the holding of hostages, including American nationals.” If successful, the lawsuit would permanently shut down NSJP and American Muslims for Palestine, a reincarnation of a previous outfit that provided material support for Hamas.

The complaint suggests that the defendants in the case just filed are carrying on in the same ways of the Holy Land Foundation before HLF, along with five of its leaders, were found guilty in a federal court at Dallas of providing material support to Hamas. They were convicted and sent to prison for, in two cases, 65 years. At the time, the assistant attorney general for national security said that the sentences “should serve as a strong warning to anyone who knowingly provides financial support to terrorists under the guise of humanitarian relief.”

The Sun asks Mr. Ostrovsky: What happens if SJP is determined to be a terrorist arm of Hamas? “The ramifications would be extraordinarily wide-ranging,” he says. “First and foremost, it would shut them down once and for all. They would not be allowed to operate in the United States, including campuses. They could not fundraise. It would be illegal to be affiliated with them. There are many other consequences, but there [sic] are a few of the main ones.”

Two significant lawsuits related to these campus outrages are directed at Northwestern University.  In the first, brought by three students, the university is charged with breach of contract.

“...alleging that the university violated its duty to abide by its own policies by allowing a climate of antisemitism on its campus.

Attorneys from the Chicago-based Much Shelist, P.C., who brought the suit in Cook County’s circuit court on Wednesday, wrote in the filing that the plaintiffs “expected Northwestern to fulfill a modest core promise it made to them and all other similarly situated, tuition-paying students: the conduct of your student peers and faculty will be governed by rules, and — once you enroll — you will be free to safely move about and avail yourself of our beautiful campus in accordance with those rules.”

“Rather than conduct the business of the campus in accordance with the clear rules of conduct that everyone signed up for,” the attorneys wrote, “Northwestern ignored those rules, opting instead to facilitate, encourage, and coddle a dystopia cesspool of hate in the school’s lush green center, Deering Meadow.”

In the second suit against the school, the Wisconsin Institute for Law and Liberty (WILL) charges that it violated Title VI, contending that the university’s concession to the protestors to award nearly $1.9 million in full-ride scholarships, faculty positions, and student-organization space to Palestinian students and staff violates Title VI’s prohibition against discrimination

Vic Bernson, Vice President and General Counsel for YAF, stated, “What Northwestern is doing here is completely pathetic. It’s a perfect encapsulation of the infantile DEI mindset in action: those committing illegal acts and spewing antisemitic bile are justified, so let’s not challenge them but instead give them everything they want and they’ll go away. But it never works that way, does it? Appease awful people making awful demands, and they’ll always respond by demanding even more. This is pure cowardice and lunacy, and YAF will fight back with every fiber of our being.”

Additional Background: On April 29, 2024, University officials entered into an agreement with anti-Israel demonstrators occupying a space on campus called Deering Meadow. The officials involved in the agreement are University President Michael Schill, Provost Kathleen Hagerty, and Vice President Susan Davis. Under the agreement, the University promised to provide the “full cost of attendance for five Palestinian undergraduates to attend Northwestern for the duration of their undergraduate careers.” 

The agreement also provides “funding two faculty per year for two years,” with the provision that these faculty will be “Palestinian faculty.” Finally, the University promises to “provide immediate temporary space for MENA/Muslim students.” MENA is an acronym for “Middle Eastern and North African” individuals. 

Our Legal Grounds: As a recipient of federal funds, the University is subject to Title VI of the Civil Rights Act of 1964, which prohibits discrimination “on the grounds of race, color, or national origin.” By providing nearly $1.9 million in scholarships, two faculty positions, and “immediate temporary space” based on an individual’s status as Palestinian or MENA, the University is intentionally discriminating against non-Palestinian or non-MENA individuals on the grounds of race, color, or national origin.

As the United States Supreme Court recently held in a case applying Title VI, race and national origin may never operate as a “negative” or a “stereotype.” Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., 600 U.S. 181, 218 (2023). Discrimination in favor of Palestinians or MENA individuals is, in turn, discrimination against individuals not within those categories and is therefore illegal under federal law. [/quote]

I think it safe to assume that more lawsuits will be filed against more colleges and universities in the coming weeks. 

Wretchard T. Cat is correct: not every university response has been identical. 

One of the encouraging things about the university response to pro-Hamas protesters has been its variety depending on the state, socio-economic composition of the student body, degree of eliteness etc. of the campus. This indicates a learning response, and adaptive strategy. This is why American society is much more resilient than it might seem. Subsidiary decision making is much more effective than a centralized state response. This is not immediately obvious but quite significant. The responses of the individual colleges, including the ivies, have been far less canned than the protesters, who dress alike, sound alike and think alike. Faced with the frat boy attack, Harvard's 3 foot fence, the water sprinkler defense they could find no answer.

Nevertheless, too many of the affected colleges and universities have failed in their mission to protect a safe learning environment for their students. The reasons are many, including reliance on foreign donations, particularly from Hamas-supporting Qatar, faculty rolls stuffed with anti-American and anti-Israeli ideologues, the DEI staff and humanities departments’ opposition to Jews and Israel, the large number of full-freight paying foreign students who do not share Western values, and the always present faculty and administrative psychological inability to handle conflict.

Still, it seems clear to me that the continued Camp Intifada ruckus and outrageous behavior are seriously damaging not only the Administration’s planned student debt relief but also the president’s reelection and the fate of his party. Rasmussen Reports notes that Trump has widened his lead over Biden by ten points (46% to 36%), and the plan to have Trump jailed on one of the numerous baloney cases recedes even further. (Among other things, Judge Aileen Cannon this week unredacted material in the Mar-a-Largo documents case showing prosecution coordination with the White House, DoJ, and NARA, and the Jack Smith team was forced to a tardy admission it had tampered with the evidence.)

My favorite senator, John Kennedy, nailed it when criticizing the President’s response to anti-Israel demonstrations on American college campuses.

JOHN KENNEDY: It should not go unnoticed that President Biden has the ability to stop all of this on a dime. All he's got to do is call the college presidents and say, look, if you don't get control of your campuses, I'm going to withhold your federal money. The president hasn't done that. The moral of the story is you're never... too old to suck. The reason he hasn't done that is because of politics. CNN just came out with a poll. It said that 52% of likely voters in America will not vote for President Biden under any circumstance, any circumstances... They would vote for the guy who salts the fries at McDonald's before they would vote for President Biden, and the White House knows this, so they're scared to alienate the not insubstantial, Hamas wing of the Democratic Party. 

[…]

What you allow is what will continue. If you allow… these jackwagons on the college campuses to continue to do what they're doing, they're going to continue to do what they're doing.

The College Democrats of America have stated their support for the anti-Israeli protestors.

As if to underscore the Administration’s cluelessness and incompetence, the Department of Education called a high-level conference on antisemitism on Friday, only notifying participants at the last moment that far-left groups that supported the campus protests had been invited to participate. The Anti-Defamation League, the Jewish Federation of North America, Hillel International, the Orthodox Union, the Louis D. Brandeis Center for Human Rights Under Law, and the Conference of Presidents of Major American Jewish Organizations withdrew, as they should have. Education Secretary Miguel Cardona, White House domestic adviser Neera Tanden, and other senior officials who were representing Biden in this “outreach” are responsible for this perfectly predictable public-relations pratfall. 

https://www.americanthinker.com/articles/2024/05/camps_intifada_students_for_theocratic_authoritarianism.html

 

J&J adds Israel to list of Middle East markets after omission raises questions

 

Customer Connect website initially listed 'Palestine,' but not Israel

Johnson & Johnson has added Israel to its directory of global markets on the company's order management website after sparking questions over why the list included "Palestine" and not the Jewish state.

The health care giant’s Customer Connect website states that it is an order management tool for the company’s direct customers and distributors in the North America, Latin America, Europe, Middle East, Africa and Asia Pacific regions and markets. 

Johnson & Johnson’s "Middle East" section lists "Palestine" among 20 markets, including Iran, Iraq, Jordan and Lebanon. When Fox News Digital checked the site on Sunday morning, there was no option for Israel.

When asked about why Israel was omitted from the site, a company spokesperson told Fox News Digital that the tool isn't used for all markets, and those customers in markets not listed, including Israel, use a different method to order products from Johnson & Johnson.

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The Johnson & Johnson Customer Connect website did not list Israel under its Middle East markets because customers in Israel use a different method to order products, a company spokesperson told Fox News Digital on Sunday. | Fox News

"The J&J Customer Connect portal is an order management tool for many but not all markets – it is not a list of all markets or regions where the Company operates or where products are sold," a company spokesperson said. "If a market is not listed on the site, it simply means that a different method of ordering is used in that market."

After Fox News Digital's inquiry and receiving questions from elsewhere about the exclusion of Israel, the spokesperson said Israel has been added to the site to clarify how customers in this market order products from Johnson & Johnson. 

Johnson & Johnson was among dozens of companies that condemned the Oct. 7 Hamas terrorist attack on Israel and spoke out against antisemitism, according to a list of companies compiled by Professor Jeffrey Sonnenfeld at the Yale School of Management. The company said it also donated $2 million to support humanitarian relief following the attack.

Johnson & Johnson has also spoken out against antisemitism following the Hamas attacks on Israel. (Mike Blake, File / Reuters Photos)

Elsewhere on the Johnson & Johnson website, a timeline that depicts the company’s "pioneering role" in the health care field from 1860 to present day shows that it opened its first operating company in Israel in 1996.

Ticker	Security	Last	Change	Change %
JNJ	JOHNSON & JOHNSON	149.27	-0.65	-0.43%

"In Israel, Johnson & Johnson has four sub-companies, all of which are guided by the Johnson & Johnson’s CREDO and its values," the company states on its "Careers in Israel" webpage. "We proudly employ over 1,000 employees across the country."

The Oct. 7 terror attack also sparked a wave of antisemitism on university campuses across the U.S., escalating in recent weeks to see student protesters and outside agitators overtaking college campuses and demanding that universities divest from Israel.

https://www.foxbusiness.com/lifestyle/pharma-giant-adds-israel-list-middle-east-markets-omission-raises-questions

Cognitive Decline: Biden Campaign Says They Will Shorten His Speeches

 Who is actually running the country?

The Biden campaign team has admitted that they are seeking to shorten his speeches, claiming that they are seeking “quality over quantity,” but leading many to presume it is because he can barely talk.

Modernity.news' Steve Watson reports that Biden Deputy Campaign manager Quentin Fulks told MSBNC:

“Our campaign believes in quality over quantity. We believe that these touches, these smaller things that are getting to the point about what is going on in the stakes of this election are gonna be easier for the voters to tap into.”

The announcement led many to ask, how much shorter can his speeches get?

At the moment he can barely manage three minutes without slurring and losing a battle with the teleprompter.

The campaign like to air pre recorded speeches, that have scores of edits and cuts in them, blatantly because he struggles to speak more than one sentence at a time.

And when Biden goes off script, he does something idiotic like calling Japan a Xenophobic country:

They are already hiding him from the press after failing to disguise that he can barely walk.

Probably because when he does encounter the press, he freezes and looks like he’s crapping himself:

Is it any wonder he is less popular than any other president in modern history:

*  * *

https://www.zerohedge.com/political/cognitive-decline-biden-campaign-says-they-will-shorten-his-speeches

RNA glioblastoma vaccine shows promise in first human trial

 A personalised vaccine for the aggressive and fatal brain cancer glioblastoma has shown encouraging signs of efficacy in its first human trial. 

The vaccine – developed by researchers at the University of Florida (UF) in the US – is based on mRNA taken from the patient’s tumour that is delivered in a lipid nanoparticle (LNP) casing that enhances their ability to stimulate the immune system.

The design aims to overcome a key limitation of regular mRNA vaccines; namely, that the immune system becomes tolerant to the antigens expressed by tumour cells thanks to immunosuppression in the tumour microenvironment (TME).

The team’s RNA-LNP approach – described in the journal Cell – works by reprogramming the TME using a sample of the tumour itself, so it can work both as a vaccine to stimulate an immune response and as an immunomodulator to counteract the effects of the TME.

“Instead of us injecting single particles, we’re injecting clusters of particles that are wrapping around each other like onions, like a bag full of onions,” said senior author Dr Elias Sayour, a UF Health paediatric oncologist who pioneered the new vaccine.

“The reason we’ve done that in the context of cancer is these clusters alert the immune system in a much more profound way than single particles would.”

Glioblastoma was chosen as a target because it is an extremely aggressive cancer that typically kills patients within 15 months, and has very few treatment options. Chemotherapy, radiation, and surgery only work for around six months before the disease re-establishes itself.

Out of the four patients treated with the RNA-LNP vaccine to date, one had progression-free survival (PFS) of eight months, another had a PFS of nine months, and a third lived for a further nine months after the glioblastoma recurred, according to a ScienceAlert report. Data on the fourth patient is not yet available.

“In less than 48 hours, we could see these tumours shifting from what we refer to as ‘cold’ – immune cold, very few immune cells, very silenced immune response – to ‘hot,’ very active immune response,” he said.

“That was very surprising given how quick this happened, and what that told us is we were able to activate the early part of the immune system very rapidly against these cancers, and that’s critical to unlock the later effects of the immune response.”

While still very early, the results do reinforce findings from an earlier study in pet dogs, which found a median survival of 139 days, much longer than the 30 to 60 days that would typically be seen in dogs with glioblastoma.

The next step will be an expanded phase I trial to include up to 24 adult and paediatric patients to validate the findings and establish a suitable dose, according to the researchers. Thereafter, a phase 2 trial in 25 children is planned, according to Sayour.

Sayour and co-author Duane Mitchell, director of the UF Clinical and Translational Science Institute, hold patents related to the vaccine, which are under option to license by iOncologi, a spin-out from the university.

https://pharmaphorum.com/news/rna-glioblastoma-vaccine-shows-promise-first-human-trial

Apple gets FDA okay to use AFib tool in clinical trials

The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduced by the FDA designed to encourage the development of medtech.

The US regulator published guidance on the Medical Device Development Tools (MDDT) framework last year, a voluntary process that aims to reduce the regulatory burden of evaluating new technologies and speed up the review process.

The approach covers a range of products, including biomarker tests, clinical outcome assessments, and non-clinical tests, and provides an endorsement that the data supports their safety, effectiveness, or performance.

The FDA notes that the Apple Atrial Fibrillation History Feature – which provides a non-invasive way to check estimates of AFib burden – has now been qualified as a biomarker test that can be used as a secondary effectiveness endpoint in clinical studies.

AFib is a type of irregular heart rhythm (arrhythmia irregular heart rhythms) where the upper chambers of the heart beat out of sync with the lower chambers, and affects around 2% of people under the age of 65 and 9% of those older, according to Centres for Disease Control and Prevention (CDC) data.

Apple’s software uses artificial intelligence to regularly check heart rhythms for signs of AFib and – after a week of measurements – provides an estimate of how often a patient’s heart was beating irregularly while wearing an Apple Watch.

Specifically, the MDDT qualification covers its use within studies intended to evaluate the safety and effectiveness of cardiac ablation devices used to treat AFib, but in principle could also apply to other studies where there is a need to provide an estimate of how long people have AFib over time.

In a 400,000-subject study of the Apple Watch’s ability to detect irregular heart rhythms that may signal AFib, published in 2019, it was found that 34% of individuals who received a notification of arrhythmia were later found to have AFib using an ECG, with a positive predictive value for the AI of 84%.

Apple has also reported anecdotal incidences of Apple Watch users receiving a warning of arrhythmia that has prompted them to seek medical advice, potentially saving their lives. The detection feature – not the history feature covered by the MDDT qualification – was approved by the FDA in 2022.

https://pharmaphorum.com/news/apple-gets-fda-okay-use-afib-tool-clinical-trials