Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced it will be added to the NASDAQ Biotechnology Index (NASDAQ: NBI), effective prior to the market open on Monday, December 18, 2023.
Wednesday, December 13, 2023
Invitae Divests Ciitizen Health Data Platform and Implements Further Cost Cuts
– Maintains Minority Equity Stake in Ciitizen –
– Anticipated Total Cash Savings of Approximately $90-100 Million on an Annualized Basis –
Trump, Dictators, and Policy
The Left has charged every Republican President since Nixon with fascism. The two presidents Bush were major targets before the campaign against President Donald Trump. Trump made fun of this during a Fox News town hall with Sean Hannity. The once and future president declared he would be “a dictator” but only on the first day of his second term when he would “close the border and drill, drill, drill” for oil and gas. This statement drew the usual outrage on the Left, confirming their warning of Trump’s authoritarianism as a threat to democracy. Of course, Trump can only get a second term if he wins a fair election, which polls currently indicate he would. That is the normal definition of democracy. But these zealots assert it is only a true democracy if they win. Any means are justified to win because they know by ideology what the people want better than the people do themselves.
Four days after the Fox event, the left-wing journal The New Republic (TNR) sent out a fundraising email exposing “Donald Trump’s favorite dictators.” But their guilt-by-association play failed when one looked at the policies being discussed.
Vladimir Putin was first, with flashbacks to the discredited “Russian collusion” hoax. What better way to smear an avowed nationalist candidate who wants to make his country great again than to allege he is a pawn of a hostile foreign power? But thrown at Trump it was unbelievable from the start. TNR cites Trump saying how “clever” Putin was in handling President Barack Obama on Crimea and deserves “a lot of credit” for taking over that strategic territory for “two dollars’ worth of sanctions.” But this does not mean Trump backs Putin. Trump’s point is that Obama was too weak to deter Putin. As was President Joe Biden who opened the door for the Russian invasion of the rest of Ukraine by declaring Kyiv was outside the NATO defense perimeter.
As Trump has said repeatedly, there would have been no invasion had he been reelected. His Secretary of State Mike Pompeo confirms in his memoir Never Give an Inch. Fighting for the America I Love the “shows of strength that President Trump put on in private conversations with Putin.” Trump also sent weapons to Ukraine along with special forces trainers, something Obama refused to do. Pompeo laments that the “partisan hysteria” regarding the Trump-Zelenskyy phone call and impeachment fiasco weaken efforts to further strengthen Ukraine. As a vocal advocate of impeachment, TNR played a part in Putin’s aggression even before backing the election of a known appeaser in 2020 who spent his first two years waving a white flag around the world. The results have been wars on multiple fronts that threaten to spread because of lackluster responses by a Biden Administration only reluctantly waking up to an extremely dangerous world.
Putin thus still thinks the U.S. will abandon Ukraine and give him a victory that will cement his revanchist regime in power for another decade. And China believes this too. A recent editorial in state media outlet Global Times asked readers to “Imagine if the US, the largest single donor to Kiev.... reduces its Ukraine aid. Amid the growing war-weariness in the West, this will certainly deflate Europe's willingness to support Ukraine. In that case, how the war will end is quite obvious.” And a “war-weary West” will eventually abandon Israel, Taiwan, and a long list of other targets to an axis of evil bent on overturning a world order upon which free people depend.
TNR’s other dictators can be dealt with just as readily. The charm offensive with Kim Jong Un was a diplomatic ploy to appeal to an isolated, immature ruler. Kim did agree to halt nuclear and long-range missile testing. On denuclearization, Trump held firmly to the position that there would be no sanctions relief until North Korea had fully dismantled its nuclear program.
It is policy disagreements that are at the core of TNR’s complaints about its last two “dictators.” Rodrigo Duterte was elected President of the Philippines in 2016 and left office at the end of his constitutionally limited four-year term. During his 20 years as mayor of Davao City he “transformed the city from a haven of lawlessness into one of the safest areas in Southeast Asia. Duterte’s harsh crime-fighting tactics earned him the nicknames ‘the Punisher’ and ‘Duterte Harry.’” This was the main issue that led to his landslide election as president. He waged a ruthless campaign against drug cartels, using vigilante and counterinsurgency tactics in a true war on crime. This won Trump’s respect and the Left’s hatred, as we see today in America.
William R. Hawkins is a former economics professor who served on the professional staff of the U.S. House Foreign Affairs Committee. He has written widely on international economics and national security issues for both professional and popular publications.
https://www.americanthinker.com/articles/2023/12/trump_dictators_and_policy.html
Final Batch Of Pfizer Covid Vax Documents Released By FDA
The FDA released the final batch of documents it relied upon in licensing Pfizer’s Comirnaty COVID-19 vaccine for ages 16 and up—more than 800 days after the agency approved the shot.
The documents are “finally in the hands of the public, where they belong,” the Informed Consent Action Network said in a press release. “Now, independent scientists and researchers can see everything FDA saw when it made its decision that this vaccine was ‘safe and effective.'”
The recent documents disclosed as part of a Freedom of Information Act (FOIA) lawsuit against the U.S. Food and Drug Administration (FDA) show the agency knew its safety monitoring system was “not sufficient” for assessing the risk of heart conditions associated with Pfizer’s COVID-19 vaccine when it licensed the company's “Comirnaty” vaccine.
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Documents also reveal numerous manufacturing problems in Pfizer batches released to the public and show the FDA knew about a phenomenon known as vaccine-associated enhanced disease (VAED) in those vaccinated who experience breakthrough COVID-19.
FDA Knew Safety Monitoring System Was 'Not Sufficient'
Federal health agencies claim COVID-19 vaccines are part of the “most intensive vaccine safety monitoring effort in U.S. history,” with “continuous” and “robust” safety monitoring that helps ensure that the vaccine's benefits outweigh any risks. Yet the final documents released from Pfizer’s biologic product file reveal the agency knew its safety monitoring program was not sufficient to assess the serious risks of myocarditis and pericarditis associated with Pfizer’s COVID-19 vaccine.
An FDA memo in the 51,893 pages of disclosures specifically addressed the agency’s CBER Sentinel Initiative and its ability to evaluate the risk for myocarditis and pericarditis following COVID-19 vaccination. The Sentinel program is the FDA’s national electronic system used to monitor the “safety of its regulated products” and is a “major part” of the agency’s mission to “protect public health.”
The memo states:
“The CBER Sentinel Program is NOT sufficient to assess the serious risks of myocarditis and pericarditis, and subclinical myocarditis associated with COMIRNATY (BNT162b2) in lieu of PMR safety studies under FDAAA [Food and Drug Administration Amendments Act].
“At the time of BLA [Biologics License Application] approval, the data sources in the CBER Sentinel Program are not sufficient to identify the outcomes due to lack of sufficient power to assess the magnitude of risk in patients 12-30 years of age. In addition, CBER Sentinel Program is not sufficient to follow up cases for recovery status and long-term sequelae, or for identification and characterization of subclinical myocarditis cases.”
Cardiac Disorders Higher in Vaccine Trial Group
According to an Aug. 23, 2021, BLA Clinical Review Memorandum, there were more cardiac disorders in trial participants who received Pfizer’s COVID-19 vaccine compared to the placebo group and more instances of tachycardia in the younger vaccinated age group.
Cardiac conditions were reported as the cause of death in nine participants 25 to 128 days after having received at least one dose of Pfizer’s COVID-19 vaccine, including seven cases of cardiac arrest, one case of cardiovascular disease, and one case of congestive heart failure.
Five cardiac-related deaths in the placebo group occurred 15 to 81 days after having received a placebo, including two cases of myocardial infarction, one aortic rupture, and two cardiac arrests.
“Because COVID-19 mRNA and its Spike protein are found in the human heart at autopsy causing inflammation and heart damage, it is incontrovertible that the COVID-19 vaccines are cardiotoxic,” cardiologist Dr. Peter McCullough told The Epoch Times in an email.
“Younger individuals with healthy hearts take up more of the damaging vaccine into the cardiac tissue resulting in symptoms of chest pain, palpitations, fluctuations in blood pressure, dizziness, and sadly, some, end up with cardiac arrest either during exercise or in the early morning waking hours. At both time periods, an internal surge of adrenalin appears to be the trigger for the fatal arrhythmia in those with COVID-19 vaccine myocarditis,” he added.
Despite nearly double the number of reported cardiac events in vaccine recipients versus placebo recipients, the FDA concluded the deaths were “unlikely to be related to vaccination.”
“As a cardiologist, these serious adverse events are unacceptable,” Dr. McCullough said. “I have called for all COVID-19 vaccines to be removed from the market with an urgent push for research strategies to prevent cardiac death after injection.”
Vaccines Released Despite Manufacturing Issues
According to the Pfizer Andover Response to Form FDA 483 included in the released documents, numerous manufacturing issues and inadequacies in quality oversight were also identified. Several batches of COVID-19 vaccines were flagged for deviating from product quality standards, yet the affected batches were released to the public in various lots, the numbers of which were redacted.
In November 2021, whistleblower Brook Jackson, who worked as a regional director at testing sites by Pfizer contractor Ventavia, told the British Medical Journal that Pfizer's trial was riddled with issues. Ms. Jackson said the company “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”
Ms. Jackson, a trained clinical trial auditor with more than 15 years of experience in clinical research coordination and management, emailed a complaint to the FDA and was fired later that day. She subsequently filed a lawsuit against Ventavia and Pfizer, alleging Pfizer had defrauded the government while developing its COVID-19 vaccine.
FDA Acknowledges Vaccine-Associated Enhanced Disease
In its Pharmacovigilance Plan Review Memorandum, the FDA referenced a condition called “vaccine-associated enhanced disease.” According to the journal Vaccine, VAED is the modified presentation of a clinical infection affecting individuals exposed to the wild-type pathogen after having received a vaccine for the same pathogen.
In its memo, the FDA stated there are reported deaths in the Vaccine Adverse Event Reporting System (VAERS) in patients reported to be fully vaccinated. Although the agency said that passive surveillance and spontaneous adverse event reporting generally cannot be used to conclude vaccine effectiveness because of the lack of a control group, reporter bias, and underreporting, “severe manifestations and death from COVID-19” increase the possibility of developing VAED, which has “overlapping clinical manifestations with natural SARS-CoV-2 infection, making it difficult to differentiate VAED from severe COVID-19 disease in individual VAERS reports.”
The FDA said Pfizer was assessing the condition in its continuation of Phase 3 clinical studies and active surveillance studies. VAED has been observed in other vaccine trials involving the dengue virus, respiratory syncytial virus, and measles.
FDA Took Over 800 Days to Release Data
The Public Health and Medical Professionals for Transparency, a nonprofit consisting of public health and medical professionals, scientists, and journalists, filed a FOIA lawsuit against the FDA in September 2021 to force the release of hundreds of thousands of documents relied upon by the agency in licensing Pfizer’s COVID-19 vaccine for individuals age 16 and older.
Even though the FDA said in a news release it was committed to “ensuring full transparency, dialogue and efficiency” regarding COVID-19 vaccines and reiterated its commitment to full transparency when it licensed Pfizer's Comirnaty vaccine, they wanted 75 years to produce an estimated 451,000 documents at a rate of 500 pages per month. It previously estimated it had 329,000 pages of responsive records and wanted 55 years to release them to the public.
Attorney Aaron Siri, who filed the lawsuit on behalf of the group, said the federal government was shielding Pfizer from liability, gave it billions of dollars, and forced Americans to get vaccinated while preventing the safety and efficacy data supporting the licensure of Pfizer’s COVID-19 vaccine from being released until the year 2076. Yet it only took 108 days from when Pfizer started producing records to the agency for the FDA to license its vaccine.
https://www.zerohedge.com/medical/final-batch-pfizer-documents-released-fda
Pentagon Seeks EMP Weapon To Eliminate Drone Swarms
Faced with the reality that drones are reshaping the modern battlefields in Ukraine and Gaza, the Pentagon has been tasked with finding a budget-friendly solution to eliminate these 'flying IEDs.' While missiles are too expensive, and laser beams are a distant dream, the next best cost-effective weapon US military officials are eyeing up could be electromagnetic pulse weapons to counter drone swarms.
According to the System for Award Management (SAM.gov) website, the US Air Force has published a contract opportunity for private industry titled "Electromagnetic Pulse (EMP) Defense Against Unmanned Aircraft Systems (UAS)."
The service outlined the drone-killing features of the new EMP weapon it is seeking:
"The Air Force Research Laboratory (AFRL/RI) is conducting market research to seek information from industry on the landscape of research and development (R&D) for available Electromagnetic Pulse (EMP) solutions towards countering multiple Unmanned Aircraft Systems (UAS). EMP solutions could be ground and/or aerial based that provide effective mitigation against Department of Defense (DoD) UAS groups 1, 2, and smaller group 3 aircraft."
As for an aerial-based EMP weapon, the service explained:
"Any EMP solutions hosted on air vehicles will have to be determined to be air-worthy by the Government. DoD must comply with the following general restrictions on UAS: 1. The air vehicle must be based on or derived from US components and electronics. 2. The air vehicle must have sufficient flight hours and reliability data."
The proposed EMP weapon would be able to neutralize drones with a directed EMP blast to damage the electronic parts - this is a much cheaper solution than missiles that cost tens of thousands of dollars, if not hundreds of thousands, a piece.
https://www.zerohedge.com/military/pentagon-seeks-emp-weapon-eliminate-drone-swarms
2020 Election: 21% of Voters Admit Fraud
Your editor is an American patriot. Through his veins courses the reddest blood.
And under red, white and blue… his heart beats true.
He cherishes American democracy in its high pristinity.
Thus he tumbles into the deepest deeps of despair today.
For he has learned that 21% of American voters flouted election law in 2020’s presidential election.
Rasmussen is his source. It conducted a recent poll of voters. That poll revealed that:
- 21% of likely voters who voted by absentee or mail-in ballot in the 2020 election say they filled out a ballot, in part or in full, on behalf of a friend or family member, such as a spouse or child…
- 19% of those who cast mail-in votes say a friend or family member filled out their ballot, in part or in full…
- 17% of mail-in voters said they cast a ballot in a state where they were no longer permanent residents…
- Among all voters, mail and in-person, 11% said a friend, family member, co-worker or other acquaintance has admitted to them they filled out a ballot on behalf of another person in 2020.
13.77 Million Americans Cast Illegal Votes
Lest doubt linger in the air: All of this runs contrary to the electoral laws of the American states.
Some 154.6 million Americans cast a vote in the 2020 presidential election.
65.6 million of them cast mailed-in votes. Thus we conclude that 13.77 million American voters mocked election law.
Yet were we not assured — assured — that the 2020 presidential election was the most “secure” election in all of history?
Mr. Justin Haskins is with the Heartland Institute — which collaborated with Rasumssen on this poll. From whom:
For the past three years, Americans have repeatedly been told that the 2020 election was the most secure in history. But if this poll’s findings are reflective of reality, the exact opposite is true. This conclusion isn’t based on conspiracy theories or suspect evidence, but rather from the responses made directly by the voters themselves.
Adds a certain Christopher Talgo of the same Heartland Institute:
The 2020 election was unlike any other in history as tens of millions of Americans voted by mail due to the COVID-19 pandemic. At the time, many experts warned that massive mail-in voting could result in widespread voter fraud. Unfortunately, these concerns were prophetic, as the results of this poll clearly show that a large number of voters did indeed fraudulently cast ballots in the 2020 election.
Not a Big Deal?
And let us restate our profound grievance with those 13.77 million voters who have pitched American elections into darkest infamy.
They have blackened our nation’s excellent name — and shattered its electoral sacraments.
“This isn’t a big deal,” you say.
“It’s mostly just people helping out their elderly parents and things like that. It doesn’t mean the ballots were fraudulent. Don’t make a story out of a non-story.”
Just so. And in many instances you are likely correct.
Yet we might remind you that each of these ballots, in all likelihood, harbored a forged signature — or no signature whatsoever.
In either case… that is… they are disqualified by law.
They were registered nonetheless. Yet a more sinister question hovers in the air…
What About the Truly Guilty?
The poll only reveals the 21% of hellcats who conceded their misdemeanors.
How many voters… who may have committed authentic election crimes… did not concede their violations?
A dozen? A thousand? Ten thousand? One hundred thousand? Zero?
The answer is not known.
Yet a well-intentioned fellow who assisted his aged and debilitated mother will concede his conduct.
If he has fractured election law, perhaps it rates a wrist slap. He has jaywalked. He is not attempting a concealment of his illegality.
He will even confess his guilt to a pollster.
Yet a man who willfully and knowingly shatters election law — perhaps by cramming dozens or hundreds of ballots into a drop box — he is a man highly conscious of his felonies.
He is unlikely to concede his guilt to a pollster. He will, nearly certainly, deny it.
What if they find out? I’m not going there.
Again we ask: How many such individuals cast illegal ballots in the presidential election of 2020?
And again we concede that we do not know. We will likely never know.
The Real Problem
Yet that is the central dilemma of the thing.
We simply do not know. All is in shadow.
It is as if an impeccable counterfeiter loads false money into an economy.
The counterfeit cannot be distinguished from the genuine.
Who can trust in the bill a fellow hands him?
And so with elections. A counterfeit vote is democratic sabotage.
It invites upon itself every manner of conspiratorial speculation.
“It was rigged!” the losing faction shouts.
The loser of the last presidential election did in fact shout it. He still does.
Is he correct? Is he partially correct? Is he entirely incorrect?
We hold no official position. We entrust that determination to you, our very dear reader.
Yet what about next year’s presidential election?
Pandora’s Box Is Wide Open
So long as the mailed-in ballot remains heavily in use, we hazard Pandora’s lovely box will remain opened.
Assume for the moment Mr. Donald J. Trump wins the Republican presidential nomination.
Assume also that he loses the election in question. Assume further that his defeat is authentic to the last degree.
That is, assume the election is not rigged or stolen in the least.
13.77 million voters have re-acquired their consciences, heeded the scolding angel on their shoulders and were seized by the spirit of George Washington — “I cannot tell a lie.”
Would Mr. Trump believe it? Would his voters believe it?
They will cite the Rasmussen poll presently under discussion.
They will remind you that 21% of 2020’s mailed-in ballots — 13.77 million of them — were illegal.
They will proceed to ask you why the 2024 presidential election was any much different.
They will further ask you why they should trust the results.
What will be your response? That the election was “safe and secure”?
How will you know it was? 21% of respondents conceded their 2020 illegalities.
And you do not know how many did not concede their 2020 illegalities.
Thus begins a beautiful chasing of the tail.
Round and round the two of you go, world without end… “It was stolen!”… “It was safe and secure!”… “It was stolen!”… “It was safe and secure!”…
Et cetera, et cetera. Et cetera, et cetera.
Restoring Faith in American Elections
Is this the granite foundation of American democracy? That millions of Americans cannot agree upon the authenticity of its elections?
If they cannot agree upon the validity of their president… upon what can they agree?
And so today we sob. We sob for the nation we cherish so.
The challenge likewise presents us with a professional grievance…
If we cannot trust election outcomes… how will we know which bloc of voters to ridicule… for electing the one scoundrel over the other scoundrel?
We will be denied that high joy. And so we take a personal interest in the resolution of this profound dilemma.
Thus, in the high spirit of national reconciliation, we depart with a proposal…
Put the mailed-in ballot under the ban. Grant its use exclusively to those who apply for it under color of law.
All others must march into an actual vote booth on the day of election.
This proposal will not bridge the nation’s vast political divisions.
Yet it may restore — to some slight degree perhaps — the dwindling American faith.
And, as said a certain Helen Keller:
“Faith is the strength by which a shattered world shall emerge into the light.”
https://dailyreckoning.com/2020-election-21-of-voters-admit-fraud/
'FBI issues warning of lone actor violence for holiday events'
The FBI warned Americans on Tuesday of potential violence perpetuated by lone actors over the holidays, as tensions continue to rise amid the Israel-Hamas war.
The FBI, the Department of Homeland Security (DHS) and National Counterterrorism Center issued a public service announcement saying the war will heighten “the threat of lone actor violence targeting large public gatherings throughout the winter.” It said large gatherings throughout the holidays might be a “convenient target” for those inspired to commit violence against Jewish, Christian, Muslim and Arab communities.
“Calls for violence may increase in the days leading up to the holidays and before other notable events this winter,” the announcement states. “Factors that could further exacerbate the threat of violence include escalations in the conflict between Israel and HAMAS and notable instances of violence in the Homeland inspiring copycat or retaliatory attacks.”
“We therefore urge everyone to remain vigilant and to report any threats of violence or suspicious activity to law enforcement,” the announcement continues.
The agencies noted that there has been a rise of “potential hate crimes or other criminal violations” since Hamas launched its surprise attack on Israel on Oct. 7, which left more than 1,200 people dead. The announcement added that there has been an increase in hoax bomb and shooting threats against synagogues across the country.
The agencies also said the announcement did not come in response to any “specific plotting activity.” The warning said due to the numerous ideologies involved, multiple targets “likely remain attractive to lone actors.”
FBI Director Christopher Wray said last week that the agency has seen a 60 percent jump in hate crime investigations across the U.S. since the outbreak of the war, with many of them targeting the Jewish community. He also said the FBI is working to prevent potential attacks inspired by Hamas as calls for violence against the U.S. have increased.
“Given the steady drumbeat of calls for attacks by foreign terrorist organizations since Oct. 7, we’re working around the clock to identify and disrupt potential attacks by those inspired by Hamas’s horrific terrorist attacks in Israel,” Wray said in an appearance before the Senate Judiciary Committee last week.
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