Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
>>> Immunocontraception -
https://en.wikipedia.org/wiki/Immunocontraception
Immunocontraception is the use of an animal's immune system to prevent it from fertilizing offspring. Contraceptives of this type are not currently available for human use.
Typically immunocontraception involves the administration of a vaccine that induces an adaptive immune response which causes an animal to become temporarily infertile. Contraceptive vaccines have been used in numerous settings for the control of wildlife populations.[1] However, experts in the field believe that major innovations are required before immunocontraception can become a practical form of contraception for human beings.[2]
Thus far immunocontraception has focused on mammals exclusively. There are several targets in mammalian sexual reproduction for immune inhibition. They can be organized into three categories.[3]
Gamete production
Organisms that undergo sexual reproduction must first produce gametes, cells which have half the typical number of chromosomes of the species. Often immunity that prevents gamete production also inhibits secondary sexual characteristics and so has effects similar to castration.[4][5]
Gamete function
After gametes are produced in sexual reproduction, two gametes must combine during fertilization to form a zygote, which again has the full typical number of chromosomes of the species. Methods that target gamete function prevent this fertilization from occurring and are true contraceptives.
Gamete outcome
Shortly after fertilization a zygote develops into a multicellular embryo that in turn develops into a larger organism. In placental mammals this process of gestation occurs inside the reproductive system of the mother of the embryo. Immunity that targets gamete outcome induces abortion of an embryo while it is within its mother's reproductive system.[6][7]
<<<
Vaccine Associated Disease Enhancement (VADE) -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164865094
Polio vaccine contaminated with cancer virus -
>>> Vaccine contamination with SV40
https://en.wikipedia.org/wiki/Vaccine_contamination_with_SV40
From Wikipedia, the free encyclopedia
Vaccine contamination with Simian vacuolating virus 40, known as SV40 occurred in the United States and other countries between 1955 and 1961.
SV40 is a virus found in monkeys and humans, which has the potential to cause cancer, in animals and humans.[1] Soon after its discovery, SV40 was identified in early batches of the oral form of the polio vaccine. The vaccines in which SV40 was found, were produced between 1955 and 1961 by Lederle (now a subsidiary of Wyeth). The contamination may have been in the original seed strain (coded SOM) or in the substrate—primary kidney cells from infected monkeys used to grow the vaccine virus during production.
Both the Sabin vaccine (oral, live virus) and the Salk vaccine (injectable, killed virus) were affected; the technique used to inactivate the polio virus in the Salk vaccine, by means of formaldehyde, did not reliably kill SV40. The contaminated vaccine continued to be distributed to the public through 1963.[2][3]
It was difficult to detect small quantities of virus until the advent of polymerase chain reaction; since then, stored samples of vaccine made after 1962 have tested negative for SV40. In 1997, Herbert Ratner of Oak Park, Illinois, gave some vials of 1955 Salk vaccine to researcher Michele Carbone.[4] Ratner, the Health Commissioner of Oak Park at the time the Salk vaccine was introduced, had kept these vials of vaccine in a refrigerator for over forty years.[5][better source needed] Upon testing this vaccine, Carbone discovered that it contained not only the SV40 strain already known to have been in the Salk vaccine (containing two 72-bp enhancers) but also the same slow-growing SV40 strain currently found in some malignant tumors and lymphomas (containing one 72-bp enhancer).[6] It is unknown how widespread the virus was among humans before the 1950s, though one study found that 12% of a sample of German medical students in 1952 – prior to the advent of the vaccines – had SV40 antibodies.[7]
An analysis presented at the Vaccine Cell Substrate Conference in 2004[8][medical citation needed] suggested that vaccines used in the former Soviet bloc countries, China, Japan, and Africa, could have been contaminated up to 1980, meaning that hundreds of millions more could have been exposed to the virus unknowingly.
Population level studies show no evidence of any increase in cancer incidence as a result of exposure,[9] though SV40 has been extensively studied.[10] A thirty-five year followup found no excess of the cancers commonly associated with SV40.[11]
References
Schipani, Vanessa (24 Apr 2018). "Did the Polio Vaccine Cause Cancer?". Factcheck.org. Retrieved 4 Mar 2020.
CDC website https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html Accessed 1 November 20166
Study Is Unsure on Tainted Polio Vaccine's Cancer Role. Denise Grady. New York Times. October 23, 2002 https://www.nytimes.com/2002/10/23/us/study-is-unsure-on-tainted-polio-vaccine-s-cancer-role.html Accessed 1 November 2016
Ferber, Dan (2002). "Virology. Monkey virus link to cancer grows stronger". Science. 296 (5570): 1012–1015. doi:10.1126/science.296.5570.1012. PMID 12004103. S2CID 32723346.
Bookchin, Debbie; Schumacher, Jim (2004). The Virus and the Vaccine. St. Martin's Press. pp. 226–28. ISBN 978-0-312-27872-4.
Rizzo, Paola; Di Resta, Ilaria; Powers, Amy; Ratner, Herbert; Carbone, Michele (1999). "Unique Strains of SV40 in Commercial Poliovaccines from 1955 Not Readily Identifiable with Current Testing for SV40 Infection". Cancer Research. 59 (24): 6103–8. PMID 10626798.
Martini, F; Corallini, A; Balatti, V; Sabbioni, S; Pancaldi, C; Tognon, M (9 July 2007). "Simian virus 40 in humans". Infectious Agents and Cancer. 2: 13. doi:10.1186/1750-9378-2-13. PMC 1941725. PMID 17620119.
Bookchin, Debbie (7 July 2004). "Vaccine scandal revives cancer fear". New Scientist.
NIH/National Cancer Institute (2004-08-25). "Studies Find No Evidence That Simian Virus 40 Is Related To Human Cancer". Science Daily.
Hilleman MR (1998). "Discovery of simian virus 40 (SV40) and its relationship to poliomyelitis virus vaccines". Dev Biol Stand. 94: 183–90. PMID 9776239.
Carroll-Pankhurst, C; Engels, EA; Strickler, HD; Goedert, JJ; Wagner, J; Mortimer EA Jr. (November 2001). "Thirty-five year mortality following receipt of SV40- contaminated polio vaccine during the neonatal period". Br J Cancer. 85 (9): 1295–7. doi:10.1054/bjoc.2001.2065. PMC 2375249. PMID 11720463.
<<<
Pfizer - >>> Legal issues
https://en.wikipedia.org/wiki/Pfizer#Controversy
Aggressive pharmaceutical marketing
See also: List of largest pharmaceutical settlements and Franklin v. Parke-Davis
Pfizer has been accused of aggressive pharmaceutical marketing.[147][148][149]
Illegal marketing of gabapentin for off-label uses
In 1993, the Food and Drug Administration (FDA) approved gabapentin only for treatment of seizures. Warner–Lambert, which merged with Pfizer in 2000, used continuing medical education and medical research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within five years, the drug was being widely used for off-label uses such as treatment of pain and psychiatric conditions. Warner–Lambert admitted to violating FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses.[150] In 2004, the company paid $430 million in one of the largest settlements to resolve criminal and civil health care liability charges. It was the first off-label promotion case successfully brought under the False Claims Act.[151] A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis.[152] The American Academy of Neurology rates it as having unproven efficacy, while the Canadian Headache Society and the European Federation of Neurological Societies rate its use as being supported by moderate and low-quality evidence.[153]
Illegal marketing of Bextra
In September 2009, Pfizer pleaded guilty to the illegal marketing of arthritis drug valdecoxib (Bextra) and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time. Pfizer promoted the sale of the drug for several uses and dosages that the Food and Drug Administration specifically declined to approve due to safety concerns. The drug was pulled from the market in 2005.[154][155] It was Pfizer's fourth such settlement in a decade.[156][157][158] The payment included $1.3 billion in criminal penalties for felony violations of the Federal Food, Drug, and Cosmetic Act, and $1.0 billion to settle allegations it had illegally promoted the drugs for uses that were not approved by the Food and Drug Administration (FDA) leading to violations under the False Claims Act as reimbursements were requested from Federal and State programs. The criminal fine was the largest ever assessed in the United States to date.[155][156][157][158] Pfizer entered a corporate integrity agreement with the Office of Inspector General that required it to make substantial structural reforms within the company, and publish to its website its post approval commitments and a searchable database of all payments to physicians made by the company.[159]
Termination of Peter Rost
Peter Rost was vice president in charge of the endocrinology division at Pharmacia before its acquisition by Pfizer. During that time he raised concerns internally about kickbacks and off-label marketing of Genotropin, Pharmacia's human growth hormone drug. Pfizer reported the Pharmacia marketing practices to the FDA and Department of Justice; Rost was unaware of this and filed an FCA lawsuit against Pfizer. Pfizer kept him employed, but isolated him until the FCA suit was unsealed in 2005. The Justice Department declined to intervene, and Pfizer fired him, and he filed a wrongful termination suit against Pfizer. Pfizer won a summary dismissal of the case, with the court ruling that the evidence showed Pfizer had decided to fire Rost prior to learning of his whistleblower activities.[160][161]
Illegal marketing of Rapamune
A "whistleblower suit" was filed in 2005 against Wyeth, which was acquired by Pfizer in 2009, alleging that the company illegally marketed sirolimus (Rapamune) for off-label uses, targeted specific doctors and medical facilities to increase sales of Rapamune, tried to get transplant patients to change from their transplant drugs to Rapamune, and specifically targeted African-Americans. According to the whistleblowers, Wyeth also provided doctors and hospitals that prescribed the drug with kickbacks such as grants, donations, and other money.[162] In 2013, the company pleaded guilty to criminal mis-branding violations under the Federal Food, Drug, and Cosmetic Act. By August 2014, it had paid $491 million in civil and criminal penalties related to Rapamune.[163]
Illegal marketing
In June 2010, health insurance network Blue Cross Blue Shield (BCBS) filed a lawsuit against Pfizer for allegedly illegally marketing drugs Bextra, Geodon and Lyrica. BCBS alleged that Pfizer used kickbacks and wrongly persuaded doctors to prescribe the drugs.[164][165] According to the lawsuit, Pfizer handed out 'misleading' materials on off-label uses, sent over 5,000 doctors on trips to the Caribbean or around the United States, and paid them $2,000 honoraria in return for listening to lectures about Bextra.[166][167] Despite Pfizer's claims that "the company's intent was pure" in fostering a legal exchange of information among doctors, an internal marketing plan revealed that Pfizer intended to train physicians "to serve as public relations spokespeople."[168] The case was settled in 2014 for $325 million.[169] Fearing that Pfizer is "too big to fail" and that prosecuting the company would result in disruptions to Medicare and Medicaid, federal prosecutors instead charged a subsidiary of a subsidiary of a subsidiary of Pfizer, which is "nothing more than a shell company whose only function is to plead guilty."[168]
Removal of ads after unflattering article
According to Harper's Magazine publisher John R. MacArthur, Pfizer withdrew "between $400,000 and a million dollars" worth of ads from Harper's Magazine following an unflattering article on depression medication.[170]
Quigley Company asbestos
The Quigley Company, which sold asbestos-containing insulation products until the early 1970s, was acquired by Pfizer in 1968. In June 2013, asbestos victims and Pfizer negotiated a settlement that required Pfizer to pay a total of $964 million: $430 million to 80% of existing plaintiffs and place an additional $535 million into a settlement trust that will compensate future plaintiffs as well as the remaining 20% of plaintiffs with claims against Pfizer and Quigley. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million is from insurance policies.[171]
Shiley defective heart valves
Pfizer purchased Shiley in 1979, at the onset of its Convexo-Concave valve ordeal, involving the Bjork–Shiley valve. Approximately 500 people died when defective heart valves fractured and, in 1994, Pfizer agreed to pay $10.75 million to settle claims by the United States Department of Justice that the company lied to get approval for the valves.[172]
Firing of employee that filed suit
A federal lawsuit was filed by a scientist claiming she got an infection by a genetically modified lentivirus while working for Pfizer, resulting in intermittent paralysis.[173] A judge dismissed the case citing a lack of evidence that the illness was caused by the virus but the jury ruled that by firing the employee, Pfizer violated laws protecting freedom of speech and whistleblowers and awarded her $1.37 million.[174]
Celebrex intellectual property
Brigham Young University (BYU) said a professor of chemistry, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that led towards development of Celebrex. BYU was originally seeking a 15% royalty on sales, equating to $9.7 billion. A research agreement had been made between BYU and Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme Dr. Simmons claims to have discovered would induce pain and inflammation while causing gastrointestinal problems and Celebrex is used to reduce those issues. A six-year battle ensued because BYU claimed that Pfizer did not give Dr. Simmons credit or compensation, while Pfizer claimed that it had met all obligations regarding the Monsanto agreement. In May 2012, Pfizer settled the allegations, agreeing to pay $450 million.[175]
Nigeria Trovafloxacin lawsuit
Main article: Abdullahi v. Pfizer, Inc.
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to Kano to set up a clinical trial and administer an experimental antibiotic, trovafloxacin, to approximately 200 children.[176] Local Kano officials reported that more than fifty children died in the experiment, while many others developed mental and physical deformities.[177] The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa.[178] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.[179] According to Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."[180] The lawsuits also accused Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. Nigerian medical personnel as well as at least one Pfizer physician said the trial was conducted without regulatory approval.[181][182]
In 2007, Pfizer published a Statement of Defense letter.[183] The letter stated that the drug's oral form was safer and easier to administer, that Trovan had been used safely in more than five thousand Americans prior to the Nigerian trial, that mortality in the patients treated by Pfizer was lower than that observed historically in African meningitis epidemics, and that no unusual side effects, unrelated to meningitis, were observed after four weeks.
In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.[184]
In December 2010, a United States diplomatic cables leak was released by WikiLeaks indicating that Pfizer hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action.[185] The Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail".[180] In response, the company released a press statement describing the allegations as "preposterous" and saying that it acted in good faith.[186] Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case,[187] was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.[188][189]
The lawsuits were eventually settled out of court. Pfizer committed to paying 35 million USD "to compensate the families of children in the study", another 30 million USD to "support healthcare initiatives in Kano", and 10 million to cover legal costs. Payouts began in 2011.[190]
<<<
>>> Dr. Robert Malone - State of the Science (Aug 2021) -
>>> The Noble Lies of COVID-19
Do we want public health officials to report facts and uncertainties transparently? Or do we want them to shape information to influence the public to take specific actions?
Slate
BY KERRINGTON POWELL AND VINAY PRASAD
JULY 28, 2021
https://slate.com/technology/2021/07/noble-lies-covid-fauci-cdc-masks.html
In March 2020, as the pandemic began, Anthony Fauci, the chief medical adviser to the president of the United States, explained in a 60 Minutes interview that he felt community use of masks was unnecessary. A few months later, he argued that his statements were not meant to imply that he felt the data to justify the use of cloth masks was insufficient. Rather, he said, had he endorsed mask wearing (of any kind), mass panic would ensue and lead to a surgical and N95 mask shortage among health care workers, who needed the masks more. Yet, emails from a Freedom of Information Act request revealed that Fauci privately gave the same advice—against mask use—suggesting it was not merely his outward stance to the broader public.
Although some have claimed that the evidence changed substantively in the early weeks of March, our assessment of the literature does not concur. We believe the evidence at the time of Fauci’s 60 Minutes interview was largely similar to that in April 2020. Thus, there are two ways to consider Fauci’s statement. One possibility is, as he says, that his initial statement was dishonest but motivated to avoid a run on masks needed by health care workers. The other is that he believed his initial statements were accurate, and he subsequently decided to advocate for cloth masks to divert attention from surgical or N95 masks, or to provide a sense of hope and control to a fearful and anxious public.
Additional evidence suggests that the second interpretation may be more accurate. In a lengthy commentary from July 2020, COVID expert Michael Osterholm wrote in detail about the continued scientific uncertainty regarding masks—even as he expressed support for their widespread public use as one measure among many. But Fauci’s reversal, which came at a time of political polarization, contributed to the evolution of masks from a basic, precautionary mitigation strategy to a badge of political allegiance. President Donald Trump was reluctant to wear a mask and justified his behavior by referring to Fauci’s comments from the 60 Minutes interview. The controversy continued into the presidential debates, with Trump mocking Joe Biden for donning the “biggest mask” he’d ever seen.
One thing is beyond a doubt, however: One of those two statements did not accurately reflect the evidence as Fauci saw it. Such high-profile mixed messages in a short time frame, without substantive new data to justify the change, generated confusion and a backlash from politicians, other experts, and the general public.
When experts or agencies deliver information to the public that they consider possibly or definitively false to further a larger, often well-meaning agenda, they are telling what is called a noble lie. Although the teller’s intentions may be pure—for example, a feeling of urgency that behavioral change is needed among the lay public—the consequences can undermine not only those intentions but also public trust in experts and science. During the first year of COVID-19, leaders were faced with an unknown disease amid a politically sensitive election in the era of social media, and the preconditions for noble lies became especially fertile. Not surprisingly, we witnessed several examples. More than anything, these examples illustrate the destructive potential of such lies.
Later in 2020, Fauci participated in a second noble lie. In December, he explained in a phone interview with then–New York Times reporter Donald McNeil that he had been moving the target estimate for herd immunity based in part on emerging studies. But he also said:
When polls said only about half of all Americans would take a vaccine, I was saying herd immunity would take 70 to 75 percent. Then, when newer surveys said 60 percent or more would take it, I thought, “I can nudge this up a bit,” so I went to 80, 85.
In his own words, he “nudged” his target range for herd immunity to promote vaccine uptake. Even though his comments were made to influence public actions to get more people vaccinated (a noble effort), the central dilemma remains: Do we want public health officials to report facts and uncertainties transparently? Or do we want them to shape information, via nudges, to influence the public to take specific actions? The former fosters an open and honest dialogue with the public to facilitate democratic policymaking. The second subverts the very idea of a democracy and implies that those who set the rules or shape the media narrative are justified in depriving the public of information that they may consider or value differently.
Aside from whether it’s right to tell noble lies in the service of eliciting socially beneficial behavior, there is also the question of efficacy. Experts on infectious diseases are not necessarily experts on social behavior. Even if we accept Fauci’s claim that he downplayed the importance of wearing masks because he didn’t want to unleash a run on masks, we might wonder how he knew that his noble lie would be more effective than simply being honest and explaining to people why it was important to assure an adequate supply of masks for medical workers.
With the arrival of vaccines in early 2021, the potential for such deliberately misleading messages to backfire became more obvious. Key opinion leaders, agencies, and the Centers for Disease Control and Prevention all articulated some version of “once you are vaccinated, nothing changes,” implying that experts did not know if it was safe to relax precautions and restrictions, such as mask wearing or social distancing, after immunization. But the stance was immediately called into question by others, including epidemiologists, who pointed to the high efficacy of the vaccines and suggested that some, but not all, social distancing measures could be relaxed in certain circumstances. Ultimately, the “no change” message, which may have been intended to discourage mass gatherings or out of a fear that unvaccinated people would lie about their vaccination status, may itself have been harmful: Surveys find that interest in vaccination increases if people are told that it means they can stop masking.
The fourth noble lie from government agencies and/or officials occurred more recently. On June 4, using data from February to March, the agency made the case that hospitalizations were rising in adolescents. It tweeted, “The report shows the importance of #COVID19 vaccination for adolescents.” That tweet spurred a great deal of media attention and concern. It was true that hospitalization rates had risen. However, at the time of the press coverage, hospitalization rates in this age group had already fallen again. Numerous commenters immediately pointed out that the “rise” in hospitalization statistic promoted by the CDC was out of date the moment it was highlighted and raised questions about why the CDC would promote a dated statistic, when the organization had access to up-to-date information.
This obvious error was compounded weeks later during a meeting of the Advisory Committee on Immunization Practices. The committee met to discuss what we knew and did not know about heart inflammation, or myocarditis, that had been linked to mRNA vaccination, and most notable in young men who received the vaccine. During the course of the meeting, representatives of the CDC showed a model that claimed that vaccination of young adults was preferable to the disease itself.
There were, however, several concerns with this model. First, it used rates of community SARS-CoV-2 spread that again were out of date. By the time of the meeting, the rates were lower, meaning the benefits of vaccination would be reduced, but the harms remain the same. Second, it did not consider the risks separately for boys and girls, who appear to have substantially different risk of myocarditis (much higher in boys). Third, it did not consider any middle ground positions, such as only receiving one dose of the vaccine, which provides much of the benefit with far lower myocarditis risk. Instead, the CDC presented zero or two doses as the only options. Fourth, the modeling did not consider natural immunity—i.e., the vaccine’s risk to kids who already recovered from COVID-19 might be the same, but the benefits far lower (as these children have some natural immunity). Finally, the model did not consider the fact that young adults with preexisting medical conditions and those who are otherwise well might have different risk benefit profiles, as the former account for a disproportionate number of COVID-19 hospitalizations.
Together, these are all information choices made by government agencies and/or officials about vaccination of young adults. Amplifying out-of-date statistics and building a model to support vaccination that has questionable assumptions work to support rapid deployment of two doses of mRNA to all healthy kids aged 12 to 17. That may be the CDC’s policy pursuit, and one we are sympathetic to. However, distorting evidence to achieve this result is a form of a noble lie. Accurately reporting current risks to adolescents, and exploring other dosing possibilities, is part of the unbiased scientific exploration of data.
We worry that vaccine policy among supporters of vaccines is increasingly anchored to the irrational views of those who oppose them—by always pursuing the opposite. Exaggerating the risk of the virus in the moment and failing to explore middle ground positions appear to be the antithesis of the anti-vax movement, which is an extremist effort to refuse vaccination. This seems a reflexive attempt to vaccinate at all costs—by creating fear in the public (despite falling adolescent rates) and pushing the notion that two doses of mRNA at the current dose level or nothing at all are the only two choices—a logical error called the fallacy of the excluded middle.
Noble lies—small untruths—yield unpredictable outcomes. Nietzsche once wrote, “Not that you lied to me, but that I no longer believe you, has shaken me.” Public health messaging is predicated on trust, which overcomes the enormous complexity of the scientific literature, creating an opportunity to communicate initiatives effectively. Still, violation of this trust renders the communication unreliable. When trust is shattered, messaging is no longer clear and straightforward, and instead results in the audience trying to reverse-engineer the statement based on their view of the speaker’s intent. Simply put, noble lies can rob confidence from the public, leading to confusion, a loss of credibility, conspiracy theories, and obfuscated policy.
Noble lies are a trap. We cannot predict the public’s behavior, and loss of trust is devastating. The general population is far too skeptical to blindly follow the advice of experts, and far too intelligent to be easily duped.
<<<
>>> Studies look at clotting, myocarditis tied to COVID-19 vaccines
Center for Infectious Disease Research and Policy
by Lianna Matt McLernon
Aug 10, 2021
https://www.cidrap.umn.edu/news-perspective/2021/08/studies-look-clotting-myocarditis-tied-covid-19-vaccines
Two studies published by JAMA Cardiology today discuss adverse effects associated with COVID-19 vaccines. The first describes vaccine-induced immune thrombotic thrombocytopenia with cerebral venous sinus thrombosis (VITT with CVST) linked to the AstraZeneca/Oxford and Johnson & Johnson vaccines. The second is a case series looking at 15 adolescents who experienced myocarditis after receiving the Pfizer/BioNTech vaccine.
Despite these risks, both research teams continue to advocate for COVID-19 vaccines as the health risks from the virus are far greater than those linked to the vaccine. For instance, the VITT study researchers say that CVST risk from COVID-19 infection is 60- to 230-fold higher than the risk derived from COVID-19 vaccination.
No current strategies to avoid VITT
Both the AstraZeneca and Johnson & Johnson COVID-19 vaccines have regulatory warnings about VITT now, and data have shown that women under 60 years old appear to be at a higher risk. Symptoms include intracranial pressure, shortness of breath, lethargy, back pain, abdominal pain, spot bleeding under the skin, and leg or arm weakness, as well as positive test results for heparin-induced thrombocytopenia (HIT). Onset occurs a median of 8 or 10 days after receiving the Johnson & Johnson or AstraZeneca COVID-19 vaccine, respectively.
CVST, one of the worst manifestations of VITT, happens when clots form in the brain and major dural sinuses. While the average 30-day mortality is 6%, about 10% of patients have permanent neurological issues 1 year later.
No current strategies exist to avoid VITT, but interim recommendations include first-line therapy with non-heparin anticoagulants and intravenous immunoglobulins (IVIG), plus second-line steroids. Platelet transfusions can be given if the patient has or is at high risk for serious bleeding, but the researchers emphasize that routine platelet transfusions are associated with a 5-fold increase in mortality, probably because they are the source of platelet factor 4. Healthcare providers should also avoid aspirin.
"The mechanism of development of the prothrombotic state and its association with the vaccine are still only partially known, because multiple converging prothrombotic pathways may be involved in the pathogenesis," the researchers write.
Although both AstraZeneca's and Johnson & Johnson's adenovirus-based COVID-19 vaccines have been connected with VITT, the syndrome seems to occur at four times the frequency with the AstraZeneca vaccine, according to the researchers. As for the mRNA COVID-19 vaccines, no instances have been recorded with the Pfizer vaccine, but three cases have been connected to Moderna.
"Adverse events like VITT, while uncommon, have been described despite vaccination remaining the most essential component in the fight against the COVID-19 pandemic. While it seems logical to consider the use of types of vaccines (eg, mRNA-based administration) in individuals at high risk, treatment should consist of therapeutic anticoagulation mostly with nonheparin products and IVIG," the researchers write.
Myocarditis appears to mostly resolve
Pfizer's COVID-19 vaccine is more associated with myocarditis, or heart inflammation, with crude analysis showing greater risk for males ages 12 to 17, according to the authors of the case series. To examine the outcomes, they looked at 15 children admitted to Boston Children's Hospital from May 1 to Jul 15 for vaccine-associated myocarditis. All but one patient was male, and the median age was 15 (children 12 to 17 are eligible for Pfizer's vaccine). None had prior, known COVID-19 infection, although one did have reactive antibodies.
Symptom onset began 1 to 6 days post-vaccine (14 cases occurred after the second dose). The whole cohort experienced chest pain, but other common symptoms were fever (10), weakness (8), and headache (6). Troponin levels were also elevated at admission (median, 0.25 nanograms per milliliter compared with 0.1) and continued increasing 0.1 to 2.3 days after admission.
Overall, 13 patients presented with myocarditis via cardiac magnetic resonance imaging. Three had decreased left ventricular ejection fraction, and five had abnormal global longitudinal or circumferential strain. Still, no patients needed intensive care unit (ICU) admission, and hospitalization stay was a median of 2 days.
At a median of 1 to 13 days after discharge, four patients still had symptoms (fatigue, 3; chest pain, 1). Troponin was mildly elevated in three patients, and one patient had nonsustained ventricular tachycardia. One of the asymptomatic cases had persistent borderline low left ventricular systolic function.
The researchers conclude, "In this case series, in short-term follow-up, patients were mildly affected. The long-term risks associated with postvaccination myocarditis remain unknown. Larger studies with longer follow-up are needed to inform recommendations for COVID-19 vaccination in this population."
<<<
This is false....
gfp927z...this is total BS!
Blood clotting is NOT associated with either the Pfizer or Moderna vaccine...
Blade, Blood clotting from the vaccines doesn't sound too great either. I also wonder about the long term side effects of these vaccines. No long term safety studies were done, and there is credible evidence out there that the vaccines don't work as designed -- 1) the spike protein cleaves off the cell and bioaccumulates in the brain and other organs, and 2) the spike protein itself is cytotoxic. These vaccines are experimental, have a completely new mechanism, and were rushed through at warp speed without the usual safety studies. No regular drug would ever be allowed to get to market like this. I'll remain skeptical.
One thing we should be demanding is that bio weapons research be ended worldwide, and the BSL-4 labs be shut down. Otherwise the same thing, or worse, will happen again. Technically there has been a ban on bioweapon development for decades, but they get around it by saying the work is for countermeasures.
I'm also not convinced that Covid wasn't deliberately released (and not by the Chinese). Lots of unanswered questions, and many people distrust government, big corporations, the media, for good reason. If they routinely lie about everything else, why should vaccines be any different? In legal speak - 'false uno, false omnibus'. So I'll remain skeptical.
gfp,
Ivermectin causing poisonings in Mississippi. This is why you and Rickards are killing people with your lies and misinformation.
HEALTH 08/20/2021 11:58 pm ET Updated 5 hours ago
Mississippi Poison Calls Soar As Vaccine Skeptics Turn To Livestock Drug For COVID-19
“You wouldn’t get your chemotherapy at a feed store,” warned a state health official. Livestock anti-parasite medication ivermectin can be deadly to humans.
headshot
By Mary Papenfuss
Mississippi health officials are pleading with state residents not to take a livestock drug to treat COVID-19 as calls to poison control centers soar.
Fearful Mississipians skeptical of the safety of vaccinations are shockingly turning instead to swallowing ivermectin — generally used to eradicate or prevent parasites in livestock.
“Do not use ivermectin products made for animals,” Mississippi’s Health Department flatly stated in a Facebook post Friday. “Animal doses are not safe for humans.”
“I think some people are trying to use it as a [COVID-19] preventative, which I think is really kind of crazy, so please don’t do that,” Mississippi State Health Officer Dr. Thomas Dobbs said at a press briefing Wednesday.
“You wouldn’t get your chemotherapy at a feed store. You wouldn’t treat your pneumonia with your animal’s medication,” he added. “It can be dangerous to get the wrong doses of medication, especially for something that’s meant for a horse or a cow. It’s really important, if people have medical needs, go through your physician or provider.”
Bladerunner
Anyone here interested in CTMX and/or FMTX? Both are trading at 52-week lows, with CTMX trading at cash value.
Bladerunner
>>> Best Biotech ETFs for Q4 2021
ARKG, IDNA, and BBH are the best biotech ETFs for Q4 2021
Investopedia
By NATHAN REIFF
Aug 12, 2021
https://www.investopedia.com/articles/investing/081415/top-3-biotech-etfs.asp?utm_campaign=quote-yahoo&utm_source=yahoo&utm_medium=referral
Biotech companies use or modify biological processes in order to create new pharmaceuticals or therapies. Some of the most prominent biotech companies include Vertex Pharmaceuticals Inc. (VRTX) and Regeneron Pharmaceuticals Inc. (REGN).
KEY TAKEAWAYS
The biotech sector underperformed the broader market over the past year.
The biotech ETFs with the best one-year trailing total return are ARKG, IDNA, and BBH.
The top holding of ARKG is Teladoc Health Inc., and the top holding of IDNA and BBH is Moderna Inc.
Investing in the biotech sector can be risky. The scientific and regulatory issues involved with gaining approval from the U.S. Food and Drug Administration (FDA) can be substantial, making it risky and difficult to predict what biotech stocks will outperform.1 One of the easiest ways to invest in the sector is through biotech exchange-traded funds (ETFs). These funds have holdings in a large array of biotech companies, offering investors a well-diversified portfolio in one easy-to-execute trade.
There are 10 biotech ETFs that trade in the U.S., excluding inverse and leveraged ETFs as well as funds with less than $50 million in assets under management (AUM). The biotech sector, as measured by the Nasdaq Biotechnology Index, has underperformed the broader market with a total return of 28.0% over the past 12 months compared to the S&P 500's total return of 34.0%, as of Aug. 10, 2021.2 The best-performing biotech ETF, based on performance over the past year, is the ARK Genomic Revolution ETF (ARKG). We examine the top three best biotech ETFs below. All numbers are as of Aug. 10, 2021.3
ARK Genomic Revolution ETF (ARKG)
Performance over One-Year: 46.2%
Expense Ratio: 0.75%
Annual Dividend Yield: 0.91%
Three-Month Average Daily Volume: 2,939,797
Assets Under Management: $8.9 billion
Inception Date: Oct. 31, 2014
Issuer: ARK
ARKG is an actively managed ETF focused on companies expected to benefit from technologies and scientific developments in genomics that could extend and enhance the quality of human and other life. The fund provides exposure to companies engaged in gene editing, therapeutics, stem cells, and bioinformatics and holds approximately 60 growth stocks of various market capitalizations.4
ARKG's top three holdings include Teladoc Health Inc. (TDOC), a provider of tele-healthcare services; Pacific Biosciences of California Inc. (PACB), a maker of systems for gene sequencing; and Fate Therapeutics Inc. (FATE), a biopharmaceutical company developing immunotherapies for cancer.5
iShares Genomics Immunology and Healthcare ETF (IDNA)
Performance over One-Year: 39.5%
Expense Ratio: 0.47%
Annual Dividend Yield: 0.16%
Three-Month Average Daily Volume: 62,820
Assets Under Management: $359.2 million
Inception Date: June 11, 2019
Issuer: BlackRock Financial Management
IDNA is a multi-cap blended fund that tracks the NYSE FactSet Global Genomics and Immuno Biopharma Index, which is made up of companies that may benefit from long-term growth and innovation in genomics, immunology, and bioengineering. The fund invests in companies from both developed and emerging markets, although the large majority of its holdings are domiciled in the U.S. or Germany.6
IDNA's top holdings include Moderna Inc. (MRNA), a pharmaceutical and biotechnology company specialized in vaccine technologies based on messenger RNA; Intellia Therapeutics Inc. (NTLA), a biotechnology company focused on CRISPR gene-editing technology; and sponsored American depositary receipts (ADRs) of BioNTech SE (BNTX), a German biotechnology company that manufactures immunotherapies.7
VanEck Vectors Biotech ETF (BBH)
Performance over One-Year: 35.2%
Expense Ratio: 0.35%
Annual Dividend Yield: 0.28%
Three-Month Average Daily Volume: 15,785
Assets Under Management: $629.3 million
Inception Date: Dec. 20, 2011
Issuer: VanEck
BBH tracks the MVIS U.S. Listed Biotech 25 Index, an index of companies involved in the development and production, sales, and marketing of therapies based on genetic analysis and diagnostic equipment. The fund is highly concentrated in a few names, with the top 10 of its 24 holdings accounting for more than 60% of all invested assets.8
BBH's top holdings include Moderna Inc.; Amgen Inc. (AMGN), a biopharmaceutical company focused on treating serious illnesses and hard to cure diseases; and sponsored ADRs of BioNTech SE.9
<<<
Thank you. Good luck if you do choose to invest.
You're assuming approval will be automatic. Even so...the label will be key and it could disappoint or be misinterpreted.
see...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165316601
Jim Rickards on Covid vaccines - >>> Tyranny
BY JAMES RICKARDS
AUGUST 17, 2021
Tyranny
I’d like to stop writing about COVID, but I can’t because it has such strong economic implications, which can’t be separated. And I’m afraid policies will be enacted that will only make things worse.
We all know the Delta variant of the COVID virus (SARS-CoV-2) is spreading rapidly in the U.S. and Australia. Major outbreaks have also hit India and Brazil.
What has received less attention is the fact that the Delta variant is now also spreading in China. That’s ironic because the virus started in China at the Wuhan Institute of Virology.
While the virus spread around the world, China quickly eliminated the spread inside China itself. Now, the virus has come full circle and is back in China in a new, more virulent form.
There’s a huge difference in how China approaches the virus from a public health perspective compared to the U.S., Japan or Europe. China’s lockdowns are far more extreme.
Why China Enforces Extreme Lockdowns
China will quickly identify an outbreak and cut off all car, train and air services to the affected area. China will also quickly shut down major ports and distribution centers if even a single case appears.
China knows that the spread of the virus is a threat to the legitimacy of the Chinese Communist Party. China cares more about Party loyalty and Party survival than it does about economic growth.
China is now imposing extreme measures, including canceling many domestic flights, closing ports and restricting vacation travel. China’s economy was already slowing before this new wave of the virus. Given China’s more extreme forms of COVID control, their economy will slow even further.
That’s bad news for China – and bad news for the world. Global growth will slow noticeably in the months ahead, partly because of the extreme nature of China’s lockdown approach.
That’s a prime example of how the virus and the economy are closely linked.
But how much do we really know about COVID? Can you really trust what the health authorities are telling you?
Science vs. Anti-Science
The essence of science is debate. One scientist will propose a hypothesis, which is then tested with experimentation. If the data from the experiment tends to confirm the hypothesis, it gains acceptance in a wider professional audience.
If the data tends to refute the hypothesis, it can be abandoned in favor of another new hypothesis. If the data are unclear, the experiments can continue. At the same time, other professionals can question the hypothesis or propose their own.
Different experts may question the experiments or challenge the interpretation of experimental data.
All of these ideas and results are published in peer-reviewed academic journals. The debate goes on until some consensus is reached. But even then, the consensus may last only until some even better view comes along. And, so it goes.
Anyone who says that the science on a particular topic is “settled” knows nothing about science because true science is never settled. It evolves. Just ask Newton, Einstein and Niels Bohr. They were three of the giants of science, yet each one revolutionized the work of their predecessors.
Unfortunately, none of the rules of real science seem to apply anymore. The “science” surrounding the COVID pandemic has been politicized, distorted, squashed and lied about to the point that citizens don’t trust their public officials – nor should they.
Censorship
One of the reasons the per capita rate of infection and fatality in Sub-Saharan Africa has been so much lower than was expected at the start of the pandemic is because Africans routinely take hydroxychloroquine to prevent malaria.
Hydroxychloroquine is cheap and safe and seems to have excellent prophylactic properties against the COVID virus. Likewise, the drug Ivermectin, which is also cheap and safe, has had fantastic results in helping to mitigate a severe outbreak of the Delta variant of the virus in India.
In India, Ivermectin may have stopped COVID dead in its tracks. 61 studies incorporating about 23,000 people revealed as much as a 96% reduction in death by taking Ivermectin.
Why have you not heard more about the role of hydroxychloroquine in Africa? Why have you not heard more about the role of Ivermectin in India? Why are both drugs not being more widely utilized to fight COVID?
The answer is that Big Tech and Big Media have banned any discussion. If you type the word hydroxychloroquine on Twitter, your tweet will be shadow-banned, or your account will be shut down. If you post something about Ivermectin on Facebook, you’ll be slapped with a “misinformation” warning label or worse.
The main TV networks – ABC, NBC and CBS (and the leading newspapers) – won’t report on these drugs and others. The news is being censored with a view to forcing vaccination with the experimental gene modification treatments from Moderna and Pfizer.
I don’t want to sound like a conspiracy theorist, but you have to ask yourself why positive news about cheap, effective therapeutics is being suppressed.
It never hurts to follow the money. It’s all about billions of dollars for Big Pharma and creating a nation that lives in fear.
Who Cares What the Science Says?
Unfortunately, the pandemic will go on because the vaccines don’t work well and wear off quickly. And, that means economic growth will continue to face headwinds. The pandemic could be mitigated with some cheap generic drugs. But it won’t be because of censorship and simple greed.
But that’s not stopping bureaucrats and politicians from demanding universal vaccination.
The COVID-19 vaccine mandate train keeps rolling down the tracks. The Biden administration said several months ago that there would be no national vaccine mandate. In the narrow technical sense, no federal mandate applicable to all citizens has been issued.
But, the spirit of Biden’s promise is now in shreds.
Instead of a single nationwide mandate, Biden has issued a large number of separate mandates to specific groups and encouraged private businesses and institutions to do likewise. The result has been practically the same as a national vaccine requirement.
The vaccine is now required for all federal officials and all government contractors. It is required for all military forces. It is required at most major universities for students returning to class. Major businesses such as Walmart, Amazon, Facebook and others require the vaccine for some or all of their employees.
Similar vaccine requirements have been imposed at the state and municipal level and by school districts, teachers’ unions and non-government organizations. Still, there are pockets of the population where the mandates don’t apply, and some individuals have been able to maintain their freedom of action.
Get Vaxxed or Live Like a Leper
Those pockets are the next targets of the vaccine pushers. Since some cannot be forced to take the vaccine, the latest tactic is to make their lives as miserable as possible until they agree to do so voluntarily. These tactics include being banned from indoor dining, concerts, sporting events, plays, movies and other social activities.
A new reign of terror being imposed on those who refuse to go along with the vaccine orthodoxy. Among the most chilling recommendations are requirements “mandating vaccines for interstate travel” and reducing Medicare payments to the unvaccinated who get COVID.
There are many legitimate reasons not to take the vaccine, including those who have already had COVID (about 35 million people with stronger antibodies than the vaccine itself produces), religious reasons, and serious doubts about side-effects and permanent changes to individual DNA genomes because of the vaccine.
None of that matters to the bureaucrats. The vaccine is being imposed whether you like it or not. Those who don’t get vaxxed will be forced into the basement of a two-tiered society and be denied access to public spaces and social interaction.
Your choice is to get vaxxed or be treated like a leper.
Regards,
Jim Rickards
for The Daily Reckoning
<<<
$IBIO iBio, Inc. is a biotechnology company, which engages in the development and manufacture of biotherapeutics. Its pipeline include idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma.
$IBIO iBio, Inc.“iBio is a global leader in plant-based biologics manufacturing. Its FastPharming System® combines vertical farming, automated hydroponics, and novel glycosylation technologies to rapidly deliver high-quality monoclonal antibodies, vaccines, bioinks and other proteins. iBio is developing proprietary products which include biopharmaceuticals for the treatment of cancers, as well as fibrotic and infectious diseases. The Company’s subsidiary, iBio CDMO LLC, provides FastPharming Contract Development and Manufacturing Services along with Glycaneering Development Services™ for advanced recombinant protein design. For more information, visit www.ibioinc.com.
https://finance.yahoo.com/news/ibio-reports-successful-preclinical-immunization-211000069.html
Buffett sells drug stocks - >>> Warren Buffett Buys More Consumer Stocks, Sells Drug Stocks, GM
Investor's Business Daily
by GILLIAN RICH
08/17/2021
https://www.investors.com/news/warren-buffett-stocks-buys-sells-berkshire-hathaway-q2-2021-13f/?src=A00220
Warren Buffett revealed more exposure to consumer stocks as Berkshire Hathaway (BRKB) posted a key regulatory filing for the second quarter of 2021 late Monday.
The highly anticipated 13-F showed Buffett added to his positions in grocery chain Kroger (KR) by 21% and high-end furniture retailer RH (RH) by 2%.
Berkshire grew its stake in insurance brokerage Aon (AON) by 7% after buying if for the first time in Q1.
Meanwhile, Buffett sold more shares in drug giants, slashing his Merck (MRK) holdings by 49%, Bristol-Myers Squibb (BMY) by 15%, and AbbVie (ABBV) by 10% after opening those positions in Q3 2020. But he did initiate a stake on Merck spinoff Organon (OGN).
Berkshire also exited its position in biotech Biogen (BIIB) and trimmed its stake in top U.S. automaker General Motors (GM) by 10%. Its Chevron (CVX) stake was cut by 2%.
Kroger shares rallied 2.8% on the stock market today, Merck edged up 0.6%, AbbVie added 0.2%, GM fell 2.9%, RH lost 2%, and Organon added 1%.
Berkshire remained a seller of stocks in Q2, according to its earnings report earlier this month.
Its net stock sales of $1.1 billion in Q2 was down from $3.9 billion in Q1, but it marked the third straight quarter of selling.
Still, the value of Berkshire's overall stock portfolio swelled 8.7% to $293.8 billion by the end of Q2. That was up from $270.4 billion in Q1, as the S&P 500 and Nasdaq hit fresh highs to close out the quarter.
Meanwhile, Berkshire bought $6 billion worth of BRKB stock in Q2. That move cam after it repurchased $6.6 billion in Q1 and a record $27.4 billion in 2020.
Buffet's stock portfolio remains highly concentrated in a handful of companies. In Q2, 69% of its aggregate value was in Apple (AAPL) ($124.3 billion) and Bank of America (BAC) ($42.6 billion). Also, American Express (AXP) ($25.1 billion), and Coca-Cola (KO) ($21.6 billion).
<<<
>>> Organon & Co. (OGN), a science-based pharmaceutical company, develops and delivers health solutions through a portfolio of prescription therapies within women's health, biosimilars, and established brands. Its women's health portfolio comprises contraception and fertility brands, such as Nexplanon/Implanon, a long-acting reversible contraceptive. The company's biosimilars portfolio consists of three immunology products, such as Brenzys, Renflexis, and Hadlima, as well as two oncology products, including Ontruzant and Aybintio in the United States, Canada, Australia, and Ukraine. It also has a portfolio of established brands in cardiovascular, respiratory, dermatology, and non-opioid pain management. The company sells its products primarily to drug wholesalers and retailers, hospitals, government agencies, and managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions. Organon & Co. was incorporated in 2020 and is based in Jersey City, New Jersey. Organon & Co. operates independently of Merck & Co., Inc. as of June 2, 2021.
<<<
“I'm not holding any bios currently. I'm waiting for RVNC approval then will probably take a position.”
Query for you…why wait for FDA as it relates to Daxi approval? Wouldn’t it me prudent to invest in RVNC now at $26 than wait until it jumps up on news of approval and launch? Is the downside too risky at this juncture? TIA for your time and comments. GLTA
Thanks, that's an interesting group of stocks. I'm also figuring on a market correction before too long. It sounds like the timeline for the Fed's tapering plans may have been accelerated, but on he other hand there is evidence that global growth rates already peaked and are now slowing. China recently had to ease credit, while the US is planning on tightening, so some mixed signals out there.
Fwiw I've mostly been out of stocks for the last month, not wanting to give back those nice 2020/21 gains. The rise of Delta seems ominous, and the stock market looks in need of a decent correction.
I'm not holding any bios currently. I'm waiting for RVNC approval then will probably take a position. I have a feeling the label will be disappointing because of misinterpretation or high expectations and will buy if it sells off. I'm more into tech stocks and currently own FUBU, STEM and TSP.
I also like AMD, ASML, SNAP, UPST, ASAN, CRWD and OPEN. I'm expecting volatility to pick up in the fall...especially if the Fed starts to taper bond purchases which will put a floor on interest rates. That should result in a 5-10% stock market correction.
Yes, good point about 'confirmation bias'.
Btw, Just curious if you have some favorite stocks you are currently following? (bio and/or non bio)
I don't follow the bio sector as closely as before, but still have a few 'on the radar'. Innovation Pharma (IPIX) is one that could start getting more attention soon with their broad spectrum antiviral Brilacidin. Their Covid Phase 2 data should be coming in Sept.
Innovation Pharma - >>> Last Patient Last Visit Completed in Innovation Pharmaceuticals’ Phase 2 Clinical Trial of Brilacidin for COVID-19; Trial Database Undergoing Review in Preparation for Database Lock
Innovation Pharmaceuticals Inc.
August 12, 2021
https://finance.yahoo.com/news/last-patient-last-visit-completed-130000435.html
WAKEFIELD, Mass., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provided additional information regarding the status of its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). The Company is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation.
Full enrollment in the 120-patient clinical trial was completed in early June 2021. The last patient follow-up visit occurred on July 30, 2021. The subject database remains blinded with the current emphasis on confirmation of all data entered at study sites, as well as completion of source data verification and the necessary checks and reviews by the data management vendor in preparation of database lock.
Following database lock and transfer to the biostatistics vendor, analysis of the unblinded data from the clinical trial will begin to assess Brilacidin’s performance, against placebo, across primary, secondary, and other endpoints. Topline results are anticipated to be available one week after database lock, with full analysis to follow.
“Our team is as excited as anyone to learn the results of our Brilacidin COVID-19 clinical trial. Everything is advancing per industry norms and standards,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We look forward to sharing Brilacidin topline data in treating COVID-19 as soon as we have it in hand.”
About Brilacidin and COVID-19
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19 (see NCT04784897). Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with laboratory testing against other viruses also underway), supporting Brilacidin’s potential to be developed as a broad-spectrum antiviral. The annual global antiviral drug market is estimated to reach $44 billion by 2026.
A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271/
Two independent Machine Learning studies identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin’s molecular properties. Click here to learn more.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
<<<
>>> BioNTech alone could lift German economy by 0.5% this year
Reuters
August 10, 2021
https://finance.yahoo.com/news/1-biontech-alone-could-lift-124733103.html
BERLIN, Aug 10 (Reuters) - The development and domestic production of a groundbreaking COVID-19 vaccine by German start-up BioNTech could boost economic growth in Europe's largest economy by up to 0.5 percentage points this year, an economist said on Tuesday.
The German economy is seen growing by roughly 4% this year following a pandemic-related plunge by 4.6% last year. This means that BionTech and its breakthrough development of a coronavirus vaccine based on mRNA technology could account for roughly an eighth of overall GDP growth in 2021, based on estimates by Sebastian Dullien, head of think tank the Macroeconomic Policy Institute (IMK).
"I can't think of another example in which a single company had such an impact on German GDP," Dullien told Reuters.
A government official said it was absolutely plausible to assume that the BioNTech effect on overall economic growth would easily reach up to 0.5 percentage points this year.
Dullien said that as a macro economist, he normally does not look at individual companies. "Sometimes, however, there are rare cases in which individual companies have macroeconomic relevance. BioNTech is such a rare example," Dullien said.
His calculations are based on BioNTech's latest earnings released on Monday which showed the start-up now expects to accrue 15.9 billion euros ($18.63 billion) in revenue from the vaccine this year, up from an earlier estimate of 12.4 billion euros.
That is roughly 0.5% of German GDP, Dullien said. In 2020, Germany's gross domestic product stood at about 3.3 trillion euros.
"Since BioNTech procures relatively few preliminary products from abroad, this is almost entirely domestic added value," Dullien said. "So this has a direct impact on economic growth."
In contrast to Germany's big car companies that produce many vehicles outside the country, BioNTech is producing its vaccine in a factory in Marburg, in western Germany. In addition, it receives licensing fees from its U.S. partner Pfizer.
BioNTech and Pfizer got the world's first approval for a COVID-19 vaccine at the end of 2020. "The success of BioNTech is impressive," Dullien said. "There is an excellent research landscape in Germany that has potential for the future."
ING Bank economist Carsten Brzeski also said Dullien's calculation was plausible, adding that BioNTech's success story was simply extraordinary.
"There aren't many companies that can go from zero to a hundred in just a year," Brzeski said.
<<<
>> who can you trust <<
Yes, the mainstream media is clearly untrustworthy, as are most government related institutions, private corporations, NGO related entities, etc. Many of the larger 'alt' media sources are also not trustworthy, and most smaller players/bloggers are just as 'in the dark' as everyone else.
So we bumble along with limited real info, while being bombarded with endless streams of mis-info and dis-info. After a while you just say screw it, life is too short. But now events are too big to ignore. In addition to this 'forever virus', how long before the economy and financial system finally come unglued for good? It's only being kept alive by continuous $ trillion infusions of new debt. The dollar reserve system is nearing the end of its useful life, to be replaced by a new paradigm.
>> You roll the dice either way <<
That sums it up pretty well. Personally, I don't believe the official side effect or efficacy statistics because, face it, these institutions routinely lie. Luckily I can stay away from indoor crowds, and use a KN-95 mask when going into a store, which is rare. But working people with families, they're stuck between a rock/hard place. I try to stay healthy, good diet, vitamins, etc. A strong immune system is still the best defense against illness.
Covid is almost certainly a souped up lab creation, made more virulent and contagious, which changes the equation. But vaccines, forget it. I remember the Swine Flu fiasco in the mid-1970's, the contaminated polio vaccines of the 1950s (contaminated with SV-40, a cancer virus), the first Hep-B vaccine (pre-Recombivax), contaminated with HIV, and the dubious Anthrax vaccines given to the US military. So excuse me for being a skeptic.
SV-40 - https://en.wikipedia.org/wiki/SV40
HIV in first Hep-B vaccine - https://pubmed.ncbi.nlm.nih.gov/3016352/
Polio, hepatitis B and AIDS: an integrative theory on a possible vaccine induced pandemic - https://pubmed.ncbi.nlm.nih.gov/11388787/
There have been less than .1% near term serious side effects reported for the mRNA vaccines and those effects are transient...not permanent.
Based on the MOA of mRNA the chances of long term side effects are next to zero IMO. The mRNA does it's job in a few days then disappears. That's a fact. There have been no blood clotting issues reported with the mRNA vaccines. The blood clotting problems are associated with the J&J and AstraZeneca vaccines which are not mRNA.
You are deathly afraid of some unknown or some side effect with very low odds of happening when the odds of contracting COVID or dying of COVID are exponentially higher. You worry about long term side effects of the vaccine with zero supporting evidence when you should be worried about long term COVID complications of which there is a mountain of evidence.
The vaccine may not protect you 100% from the Delta variant but data so far shows that if you are vaccinated and contract the Delta the infection will be much milder and your chances of hospitalization or death are minimal compared to contracting Delta while unvaccinated.
You roll the dice either way. Getting vaccinated is a no-brainer to me. Your odds of dying or serious illness are exponentially higher if you remain unvaccinated.
Biocqr, Yes, but to find out if a specific drug or vaccine works as designed, and determine its safety/side effects, requires the full animal and human testing process, and this wasn't done with these vaccines. They rushed them out without full testing.
Then in May, the CDC stopped even looking for side effects or efficacy among the vaccinated (article below), just as they (CDC) were removing the mask and distancing recommendations. Now it turns out vaccinated people can harbor just as much virus and be just as contagious as the non-vaxed. We already knew about the blood clots associated with the vaccines, and there are credible reports that the spike protein cleaves off and bioaccumulates in the brain and organs, and is itself cytotoxic.
With all the confusion and conflicting narratives, the public is faced with - 1) an engineered virus, or 2) an engineered virus plus an engineered vaccine. It's a dilemma, the vaccine may no longer work that well on the variants, and may have serious near term side effects along with unknown longer term effects.
Fwiw, I'll always remain a skeptic when it comes to Big Pharma, FDA, CDC, NIH since there are many sound reasons to distrust these institutions.
>>> CDC Scaled Back Hunt for Breakthrough Cases Just as the Delta Variant Grew
Bloomberg identified more than 100,000 vaccine breakthroughs
Bloomberg
By Drew Armstrong, Rebecca Torrence, and Fiona Rutherford
July 30, 2021
https://www.bloomberg.com/news/articles/2021-07-30/cdc-scaled-back-hunt-for-breakthrough-cases-just-as-the-delta-variant-grew
The U.S. agency leading the fight against Covid-19 gave up a crucial surveillance tool tracking the effectiveness of vaccines just as a troublesome new variant of the virus was emerging.
While the Centers for Disease Control and Prevention stopped comprehensively tracking what are known as vaccine breakthrough cases in May, the consequences of that choice are only now beginning to show.
At the time, the agency had identified only 10,262 cases across the U.S. where a fully vaccinated person had tested positive for Covid. Most people who got infected after vaccination showed few symptoms, and appeared to be at low risk of infecting others.
But in the months since, the number of vaccine breakthrough cases has grown, as has the risk that they present. And while the CDC has stopped tracking such cases, many states have not. Bloomberg gathered data from 35 states and identified 111,748 vaccine breakthrough cases through the end of July, more than 10 times the CDC’s end-of-April tally...
<<<
Full article -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165209093
Event 201 - US Coronavirus exercise Oct 18, 2019 -
https://en.wikipedia.org/wiki/Johns_Hopkins_Center_for_Health_Security#Event_201
Event 201
On October 18, 2019, the CHS partnered with the World Economic Forum and the Bill and Melinda Gates Foundation to host the tabletop exercise Event 201 in New York City.[29] According to the CHS, "[t]he exercise illustrated areas where public/private partnerships will be necessary during the response to a severe pandemic in order to diminish large-scale economic and societal consequences".[29]
Event 201 simulated the effects of a fictional coronavirus originating in bats but passing to humans via pigs.[30] Claims that Event 201 was a rehearsal for the world's response to COVID-19 have been declared invalid by fact-checking outlets such as USA Today and FullFact. [30][31]
<<<
>>> Congress is investigating whether the 2019 Military World Games in Wuhan was a covid-19 super-spreader event
The Washington Post
by Josh Rogin
June 23, 2021
https://www.washingtonpost.com/opinions/2021/06/23/congress-wuhan-military-games-2019-covid/
In October 2019, more than 9,000 international athletes from more than 100 countries traveled to Wuhan, China — and many of them later got sick with covid-19-like symptoms. But there has never been a real investigation into whether the virus that causes covid-19 was already spreading at the Wuhan Military World Games. Now, multiple U.S. lawmakers are demanding the U.S. government begin one.
... The State Department’s only consideration of the Wuhan Military World Games came when the Chinese foreign ministry began citing the event in its own propaganda in March 2020. The Chinese asserted that U.S. Army personnel might have brought the virus to Wuhan from Fort Detrick in Frederick, Md., where the U.S. Army bioresearch program is based. That didn’t make sense because the first outbreak was in Wuhan, not Maryland. But the Trump team never took it any further than that.
<<<
Full article -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164870279
Biocqr, Normally these new mRNA vaccines would have to go through many years of clinical trials and safety studies. The headlong drive to vaccinate the earth's population seems very risky considering -
1) The vaccines are experimental and have not been fully tested
2) They have a brand new mechanism that has never been used before in a vaccine, ie gene therapy/modification
3) No long term safety studies have been done
4) We're talking about almost everyone on the planet getting this experimental treatment
As bad as Covid is, let's hope the long term effects of the treatment don't turn out to be worse than the pandemic itself.
One discussion the country/world should have is how to close these BSL-4 labs and end bioweapons testing and development. Countries get around the existing bio weapons ban by calling it 'research to develop countermeasures'. But something needs to be done or more lab leaks are inevitable, and future pathogens could be much worse than Covid. Biological agents are much easier for smaller countries / groups to obtain, compared to say nuclear weapons, so a dangerous future for the world.
Blade, Sorry to hear about your friend. I think there have been lies and misinformation coming from both sides of the Covid/vaccine arena.
But there is some credible evidence that the mRNA vaccines may have major problems - 1) the spike protein cleaves off and bioaccumulates in the organs and brain, and 2) the spike protein itself exhibits cytotoxicity -
Right-wing radio host who attacked Dr. Fauci changed his tune on his deathbed.
https://www.huffpost.com/entry/dick-farrel-newsmax-right-wing-scamdemic-dies-of-covid_n_610f50d3e4b041dfbaaabac6?utm_source=spotim&utm_medium=spotim_recirculation
Bladerunner
P.S. One of my closest friends died of COVID last week. Two weeks previously he had lost both parents to COVID. All of them had refused to be vaccinated. My friend was young and completely healthy and though he was invulnerable. He dies three days after entering the hospital. This virus is deadly and very contagious. To my mind, all those who are spreading lies and misinformation about COVID and the vaccinations, including the moderator of this board, have the blood of my friend and many others on their hands.
Rickards - >>> Stop the Lies
BY JAMES RICKARDS
AUGUST 3, 2021
https://dailyreckoning.com/stop-the-lies/
Stop the Lies
Health officials continue to lose credibility over COVID-19. They seem to change their minds daily based on whim rather than science. But that’s been the case since the pandemic started.
Going back to last January, official comments on COVID have been mostly wrong. The comments were either outright lies or were prescriptions based on politics, not medicine.
In January 2020, the World Health Organization said there was no human-to-human transmission of COVID. They knew better because of data from China, so that was a lie. Dr. Anthony Fauci said there was little risk of COVID coming from China to the U.S. Another lie.
Then, over the course of 15 months, Fauci said not to wear masks, then he said to wear them, then he said you could take them off. Now, he says it’s time to put them on again.
Fauci is an over-the-hill bureaucrat, not a true scientist. His greatest skill has been successfully navigating the Washington swamp for the past four decades. He’s heavily conflicted because he owns patents on inputs to the vaccines.
He also has a lot to hide, because he funded the Wuhan laboratory coronavirus research in the first place. The science is clear that masks don’t work (because the virus is far smaller than the mask weave), and lockdowns don’t work (because people indoors in confined spaces spread the virus faster than people outside who are in motion).
Masks are positively dangerous for children because they force you to breathe your own CO2, which causes dizziness, lethargy, inability to focus and can cause people to pass out. The latest lie is Biden’s call for vaccine mandates for federal workers or weekly testing, masking and distancing.
What Vaccine Mandate?
The White House had repeatedly said there would be no federal vaccine mandates. It’s true that there is no single mandate that applies to all Americans. But there are now hundreds of mini-mandates that add up to the same thing.
Biden’s federal worker mandate covers 4 million federal employees and as many as 4 million federal contractors.
Meanwhile, universities are imposing vaccine mandates on returning students. Large companies like Facebook and Google are imposing vaccine mandates on their workers. New York State has imposed a vaccine mandate on state workers. Sports and entertainment venues are barring anyone who cannot prove they have been vaccinated.
When you add it all up, we’re turning into a society of vaxxed and unvaxxed where the latter are denied the opportunity to work, attend school, go out for a show or sporting event and so on.
“There is no vaccine mandate,” they’ll say. But in reality, the unvaccinated will be treated as second-class citizens who can’t live regular lives or participate fully in society.
Why Are So Many Vaccinated People Getting Sick?
This is all over so-called vaccines that are really experimental gene modification treatments with dangerous side effects and limited efficacy since many vaccinated individuals are now being infected again. The vaccines won’t stop you from getting the virus or from spreading it.
In one Massachusetts town, for example, 74% of new cases have already been vaccinated. Data from overseas is even more revealing since many countries report new cases daily, which doesn’t allow for the type of data manipulation U.S. health agencies often engage in.
In Israel, about 85% of adults over 30 are fully vaccinated. Over 90% of those above 60 are fully vaccinated. But Israel is experiencing a dramatic rise in new cases. The number of serious cases has increased about 10 times since the beginning of July. Importantly, the vast majority are vaccinated.
The data reveal that rates of severe cases among the vaccinated are currently as high as the unvaccinated’s rate just two weeks ago.
The Israeli Prime Minister, Naftali Bennett, warns that cases may quadruple within three weeks and that authorities are preparing for new lockdowns (even though lockdowns have proven to be ineffective against stopping the virus).
Most Israelis have taken the Pfizer vaccine, incidentally.
Gene Therapy
But why should these vaccines stop you from getting the virus or from spreading it? Again, these aren’t vaccines in the traditional sense, which introduce weakened or inactive parts of a virus, against which your body produces antibodies.
Instead, these COVID vaccines introduce mRNA (messenger RNA) into your muscle cells. The cells then reproduce the spike protein. These vaccines are, therefore, a form of gene therapy.
Fauci has said that the recent surge in infections is a “pandemic of the unvaccinated,” that 99% of deaths were unvaccinated. But that’s another lie. The CDC’s own data indicated that 15% of fatalities occurred among the unvaccinated during the period in question. There’s reason to believe the actual figures are higher.
But the demands for universal vaccination continue. The American Medical Association (AMA) has reported that 96% of practicing physicians are fully vaccinated, based on a poll of 300 respondents.
The point is to try to convince those who aren’t vaccinated that if almost all doctors are vaccinated, you should be too. But a separate survey of 700 participants conducted by the Association of American Physicians and Surgeons (AAPS) revealed that nearly 60% of respondents said they were not “fully vaccinated.”
Which numbers do you believe are more likely?
Cheap, Effective Therapeutics Are Suppressed
At the same time, health authorities have suppressed cheap, effective therapeutics like Ivermectin and hydroxychloroquine that can significantly reduce COVID hospitalizations and deaths. These drugs have been around for decades and are extremely safe.
But the alphabet soup of health agencies says they need more testing before they can be approved. Yet these are the same people who are shoving experimental gene therapy down people’s throats, which were rushed through on an emergency basis without the usual testing that takes years.
Any health professional who cites the benefits of these therapeutics can be banned from social media, despite numerous clinical studies that demonstrate their effectiveness, especially if used in the early stages of illness. They aren’t magic bullets, but the data indicate they provide substantial benefit.
Why are public health authorities so determined to suppress these cheap but effective therapeutics? Well, you might want to follow the money.
The FDA granted emergency use approval for the vaccines. But for the FDA to grant that emergency approval, “no formally approved alternatives” can be available at the time.
If these other therapeutics were deemed effective, the vaccines couldn’t be rushed through on an emergency basis. And a lot of powerful interests stood to profit from the vaccines. They wouldn’t profit from off-patent therapeutic drugs that might cost pennies per pill.
Meanwhile, the push for new lockdowns, universal vaccination and vaccine passports continues.
It’s a Brave New World, and it’s not going away soon.
Regards,
Jim Rickards
for The Daily Reckoning
<<<
Axsome Therapeutics - >>> 3 “Strong Buy” Stocks Trading at Steep Discounts
TipRanks
August 2, 2021
https://finance.yahoo.com/news/3-strong-buy-stocks-trading-142616588.html
How do you define a stock market opportunity? Is it a windfall, a piece of luck, or the result of careful planning, a strategy to make the most of any opening? The savvy investor seeks out the latter, looking for stocks that offer inducements to entry, be it a high upside or a depressed share price or a recent positive analyst review – or better yet, a combination of all three.
So there’s a profile. We’ve used the TipRanks database to look up three stocks that fit it – stocks with Strong Buy consensus ratings, plenty of upside potential, and recent thumbs up from the analyst corps. And, while these stocks have plenty of positives in the profile, each one has also seen steep share price losses in recent weeks. Let's take a closer look.
Axsome Therapeutics (AXSM)
We’ll start with Axsome, a biopharma research company working on new medication therapies for diseases of the central nervous system (CNS). Axsome’s target conditions currently have limited treatment options – and also have a deep potential patient base. The company is researching medications with ‘novel mechanisms of action’ as a way to transform the approach to CNS treatment. The company is investigating treatments for a varied range of conditions, from Alzheimer’s, to fibromyalgia, to severe migraines, to depression.
Axsome currently has four drug candidates in the development pipeline. The leading candidate, AXS-05, is a multimodal treatment, developed to treat major depressive disorder, Alzheimer’s-related agitation, and smoking cessation. The depressive disorder track, for which AXS-05 has a breakthrough therapy designation, is farthest along – the New Drug Application has been submitted, and the FDA has given a PDUFA target date of August 22 this year. If approved, the company plans to launch commercially in 4Q21. On the Alzheimer’s track, AXS-05 is currently undergoing the Phase 3, double-blind ACCORD study. Enrollment is currently ongoing.
The next big update for the company is planned NDA submission for AXS-14, a new treatment for fibromyalgia. This drug candidate has competed two trials, a Phase 2 with 267 patients and a Phase 3 with 1,122 patients, both with positive results. Data from the trials will be included in the NDA submission, which is planned for Q4 of 2022.
Finally, Axsome has AXS-7 as a migraine treatment. This candidate has demonstrated effective pain relief in patients within two hours of dosing, and has a potential patient base of 37 million. The company has an NDA in preparation for this drug candidate, and hopes for approval next year.
The pipeline is the key point here, and Berenberg’s Esther Hong bases her Buy rating on the potential of AXS-05 as a treatment for major depressive disorder.
“We are bullish on the prospects and see a potential commercial launch in Q4 2021. Second, the company expects to submit a new drug application (NDA) with the FDA this quarter for a second product (AXS-07 for the treatment of migraine). Approval could come in 2022. We see opportunity for significant price appreciation over the remainder of the year driven by these key upcoming catalysts with longer-term upside from a robust pipeline,” Hong opined.
The analyst added, "We are bullish on the prospects for AXS-05 in MDD due to 1) its robust efficacy in treating depression as a result of its novel mechanism of action [MOA]; 2) the speed of efficacy compared to traditional antidepressants; and 3) a superior safety profile compared to other NMDA antagonist antidepressants..."
Hong puts a $112 price target on the stock, suggesting an upside of 123% for the year ahead. (To watch Hong’s track record, click here)
With a unanimous Strong Buy consensus rating, based on 8 recent reviews, it’s clear that Wall Street agrees with Hong on the potential of this stock. The shares fell in the past year, mainly due to regulator hurdles, but in the Street’s estimation, that has opened up an opportunity. The stock is selling for $50.27 and has an average target of $135.33, indicating room for ~170% upside potential this year. (See AXSM stock analysis on TipRanks)
<<<
Humanigen - >>> Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients
Yahoo Finance
August 4, 2021
https://finance.yahoo.com/news/lenzilumab-treatment-may-enhanced-likelihood-100000585.html
Lenzilumab treatment in Black and African-American patients in the positive LIVE-AIR Phase 3 trial, having a CRP<150 mg/L, resulted in a nearly 9-fold increase in survival without ventilation
CDC data shows Black and African-American persons are at an almost 3-fold greater risk of hospitalization and 2-fold greater risk of death from COVID-19 infection1
Black American vaccination rates are lowest nationally, resulting in higher risk of infection, hospitalization, and death2
BURLINGAME, Calif., August 04, 2021--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’, announced analysis of results from its Phase 3 LIVE-AIR study of lenzilumab in hospitalized patients with COVID-19 suggesting Black and African-American patients having a CRP<150 mg/L may be the highest responders to treatment, with a nearly 9-fold increase in likelihood of survival without ventilation (SWOV) [n=51, p-value=0.0412]. In the overall population with CRP<150 mg/L, LIVE-AIR Phase 3 results show patients treated with lenzilumab demonstrated a 2.5-fold increased likelihood of SWOV [mITT, n=351, p-value=0.0009].
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005396/en/
"Humanigen believes this analysis is an important finding because Black and African-American patients are hyper-vulnerable to COVID-19," said Cameron Durrant, MD, Chief Executive Officer, Humanigen. "In light of the rapid ongoing spread of the Delta variant, data suggesting that Black and African-American patients, who are hyper-vulnerable to COVID-19, and may be hyper-responsive to lenzilumab is important in the broader context of the potential benefits that may result if the FDA were to grant emergency use authorization."
The Centers for Disease Control and Prevention (CDC) has found that race and ethnicity are risk markers for other conditions that affect health, including socioeconomic status, access to health care, and exposure to SARS-CoV-2 related to occupation, such as frontline, essential, and critical infrastructure workers.1 The American Heart Association’s COVID-19 Cardiovascular Disease Registry found that Black patients had the highest prevalence of obesity, hypertension, and diabetes, all of which are medical conditions the CDC identifies as making adults of any age more likely to get severely ill from COVID-19.3,4
"In the interest of public health and safety, it is our priority to share data with stakeholders to improve our understanding of the disease and potential treatments," said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen. "While there may be some limitations to subset analyses, we believe the ongoing public health crisis caused by SARS-CoV-2 warrants consideration of these important data by regulatory authorities."
Humanigen intends to submit data from this analysis for publication in a peer-reviewed journal and present the findings at a medical meeting. These new data from the LIVE-AIR study will also be shared with regulatory authorities in the US, UK, European Union, and other geographies.
About the LIVE-AIR, Phase 3 Study of Lenzilumab
LIVE-AIR Phase 3 study met its primary endpoint of survival without ventilation demonstrating a 1.54-fold improvement overall and trended to a 2.68-fold improvement in Black and African-American patients. This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated ‘cytokine storm’ and improve survival without ventilation, or ‘SWOV’ (sometimes referred to as ‘ventilator-free survival’). SWOV is a composite endpoint of time to death and time to invasive mechanical ventilation (IMV), which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.5
The LIVE-AIR study enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation; and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through day 28 following treatment. Key secondary endpoints, also measured through day 28, included ventilator-free days, duration of ICU stay, incidence of IMV, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial have been submitted for publication in a peer-reviewed journal.
About Humanigen, Inc.
Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with CD19-targeted CAR-T cell therapies and exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease (aGvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT), eosinophilic asthma, and rheumatoid arthritis. Humanigen is also developing a portfolio of clinical and pre-clinical therapies for the treatment of inflammation and immuno-oncology. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.
<<<
>>> David E. Martin - Covid-19, Vaccinations, and Other Mass Casualty Events <<<
https://kunstler.com/podcast/kunstlercast-347-chatting-with-david-e-martin-about-covid-19-vaccinations-and-other-mass-casualty-events/
Blade, That info sounded credible enough to at least justify further research.
What definitely sounds like crapola is the lockstep mainstream narrative surrounding these vaccines, complete with censorship of all who question it, including prominent scientists. 200,000 posters were reportedly booted off of Facebook, so what's that all about? Something's not right here.
What do you make of this? (link below) Sounds credible to me -
gfp,
Why are you posting this horseshit here? I remember you as a fairly reasonable guy, and now you're spouting Tucker Carlson-type crapola. What's happened to you? Why are you drinking the FOX Kool-Aid? You should stop posting this junk science horse manure.
Blade
$IBIO Covid19 1.27 +0.0299 (2.41%)
$CEMI $28.3 million purchase order from Bio-Manguinhos for the purchase of Chembio's COVID-19 antigen tests. https://markets.businessinsider.com/news/stocks/chembio-diagnostics-stock-price-cemi-covid-test-order-investing-retail-2021-7
Name | Symbol | % Assets |
---|---|---|
Newmont Corp | NEM | 12.36% |
Barrick Gold Corp | ABX.TO | 11.02% |
Franco-Nevada Corp | FNV.TO | 7.17% |
Newcrest Mining Ltd | NCM.AX | 5.15% |
Agnico Eagle Mines Ltd | AEM.TO | 4.96% |
Wheaton Precious Metals Corp | WPM.TO | 4.95% |
Anglogold Ashanti Ltd ADR | AU.JO | 4.14% |
Kirkland Lake Gold Ltd | KL.TO | 4.07% |
Royal Gold Inc | RGLD | 3.70% |
Kinross Gold Corp | K.TO | 3.11% |
Name | Symbol | % Assets |
---|---|---|
Kinross Gold Corp | K.TO | 6.00% |
Northern Star Resources Ltd | NST.AX | 6.00% |
Sibanye-Stillwater ADR | SBGL.JO | 5.99% |
Pan American Silver Corp | PAAS.TO | 5.49% |
Gold Fields Ltd ADR | GFI.JO | 4.60% |
Yamana Gold Inc | YRI.TO | 4.40% |
Evolution Mining Ltd | EVN.AX | 4.00% |
B2Gold Corp | BTO.TO | 3.73% |
Buenaventura Mining Co Inc ADR | BVN | 2.99% |
Saracen Mineral Holdings Ltd | SAR.AX | 2.95% |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |