IMX-110 produced a 50% response rate after 1 cycle of treatment as a monotherapy in first-line-therapy-resistant cancer - soft tissue sarcoma (STS) mice study
IMX-110 response rate surpassed standard of care doxorubicin’s response rate of 0% after 1 cycle of treatment in the same study
IMX-110 is in clinical development for STS, a $3 billion market expected to grow to $6.5 billion by 2030
The practice of making vaccinations mandatory within a population has always been controversial. Historically, the first example of this was during thesmallpox epidemic in the 1800s, when some European countries attempted to make vaccination against the disease compulsory.
While it is hard to argue against the overall aim of disease eradication, there are many ethical, medical, and social issues intertwined with the idea of enforcing vaccination.
However, in recent months, there has been a resurgence in conversation on this topic, with the ongoing pandemic prompting nations around the world to consider whether mandatory vaccination against COVID-19 is an appropriate measure to introduce for certain people groups or even entire populations.
Healthcare professionals have their say
Over a four-month period between 11th July and 11th November 2021, 23,186 healthcare professionals (HCPs) worldwide posted on social media 188,235 times discussing the topic of mandatory vaccination. It is important to note that this is a highly disputed issue among HCPs, which has brought many varying opinions to the forefront.
The two main contrasting perspectives taken by HCPs are:
Those who believe vaccine mandates are absolutely necessary.
Those who believe that vaccines should be encouraged but not mandatory.
They encouraged those who oppose the mandate proposals by saying that vaccine mandates or passports are simply an extension of immunisation records, which are kept by billions of people around the world. HCPs referenced the historical mandatory vaccine against smallpox as proof of the effectiveness of mass vaccination.
HCPs make comparisons with other vaccine mandates
In addition to COVID-19, which dominated HCP discussions, other key diseases mentioned in the context of mandatory vaccines included measles, polio and influenza.
When discussing these diseases, HCPs were mainly referring to existing vaccine mandate policies, which stipulate, for example, that in many places around the world.
For example, parts of the US and Canada, children must be vaccinated against diseases including measles and polio before attending school, and those working in hospitals in many areas must also prove their vaccination status in order to be permitted to work.
The question arising from this comparison was – why should COVID-19 be treated any differently?
Pro-vaccine, anti-mandate
The second, contrasting, and more commonly expressed opinion of HCPs on social media is that vaccines are positive and should be highly encouraged but not enforced.
Whilst many HCPs with this view describe themselves as ‘pro-vaccine’, contrary to the above, they believe that vaccinations should indeed be a matter of personal choice and consent, and therefore presented arguments against the rollout of vaccine mandates or passports. HCPs also defended themselves when they came under fire from others, reinforcing the difference between opposing vaccine mandates, and opposing vaccines themselves.
Another interesting point of view offered by some HCPs suggested that most people are not opposed to the vaccine; they simply do not believe in its importance for their own health but would get vaccinated if required to preserve their personal freedom.
HCPs weigh up large-scale vaccine mandate in United States
When analysing the daily social media activity of HCPs relating to mandatory vaccination, it is clear that the conversation reached its peak volume between 9-11 September. HCPs used social media as a platform to react to an announcement from US President Joe Biden regarding a new vaccine mandate that is anticipated to apply to about two-thirds of all US employees. The mandate itself requires anyone who works for a business with more than 100 employees to be fully vaccinated, with companies warned of substantial fines should they violate these rules.
HCPs offered many of the opinions explored earlier in this article, while also questioning why members of Congress have been made exempt from this rule. Another key concern expressed by HCPs was the segregation that may be caused as a result of the low vaccine uptake among the black and minority communities.
Keep monitoring the conversation
HCPs have been using social media to articulate their views about compulsory vaccination, with a wide variety of opinions underpinned by health, social and ethical factors.
While some HCPs support the idea of mandatory vaccination, most favour an individual-centred approach where vaccines are encouraged but not enforced. As the world waits to see the effects of COVID-19 vaccine mandates imposed by some nations, CREATION.co is monitoring the ongoing conversation.
Intuitive (the “Company”) (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced certain unaudited preliminary fourth quarter and full year 2021 financial results ahead of its participation at the 40th Annual J.P. Morgan Healthcare Conference occurring January 10-13, 2022.
Financial and Operational Highlights
Fourth quarter 2021 worldwide da Vinci procedures grew approximately 19% compared with the fourth quarter of 2020. The fourth quarter of 2020 reflected significant disruption caused by the COVID-19 pandemic, and the fourth quarter of 2021 reflected a COVID-19 resurgence later in the quarter, which also impacted our procedures. The compound annual growth rate between the fourth quarter of 2019 and the fourth quarter of 2021 was approximately 13%.
Full year 2021 worldwide da Vinci procedures grew approximately 28% compared with 2020. The compound annual growth rate between the full year of 2019 and the full year of 2021 was approximately 14%. The Company expects worldwide da Vinci procedures to increase approximately 11% to 15% in 2022 as compared to 2021.
The Company shipped 385 da Vinci Surgical Systems in the fourth quarter of 2021, an increase of 18% compared with 326 in the fourth quarter of 2020. The Company shipped 1,347 da Vinci Surgical Systems in 2021, an increase of 44% compared with 936 systems in 2020.
Preliminary fourth quarter 2021 revenue of approximately $1.55 billion increased 17% compared with $1.33 billion in the fourth quarter of 2020. The compound annual growth rate between the fourth quarter of 2019 and the fourth quarter of 2021 was approximately 10%. Preliminary 2021 revenue of approximately $5.71 billion increased 31% compared with $4.36 billion in 2020. The compound annual growth rate between the full year of 2019 and the full year of 2021 was approximately 13%.
Fourth quarter 2021 expenses included a $30 million contribution to the Intuitive Foundation.
In December 2021, the Company received U.S. Food and Drug Administration clearance for the 8 mm SureForm 30 Curved-Tip Stapler and reloads (gray, white, and blue) for use in general, thoracic, gynecologic, urologic, and pediatric surgery. The stapler has been designed to help surgeons better visualize and reach anatomy through a combination of the 8 mm diameter instrument shaft and jaws, 120-degree cone of wristed articulation, and the curved tip.
Preliminary Results
The Company expects fourth quarter 2021 revenue of approximately $1.55 billion, an increase of 17% compared with $1.33 billion in the fourth quarter of 2020. The compound annual growth rate between the fourth quarter of 2019 and the fourth quarter of 2021 was approximately 10%. The Company expects 2021 revenue of approximately $5.71 billion, an increase of 31% compared with $4.36 billion in 2020. The compound annual growth rate between the full year of 2019 and the full year of 2021 was approximately 13%. The unaudited results in this press release are preliminary and subject to the completion of the Company’s final closing procedures and annual independent audit and, therefore, are subject to adjustment.
Preliminary fourth quarter 2021 instruments and accessories revenue increased by 13% to approximately $843 million, compared with $747 million in the fourth quarter of 2020, primarily driven by growth in da Vinci procedure volume, partially offset by stocking orders in the prior year associated with the Company’s launch of Extended Use Instruments. The compound annual growth rate between the fourth quarter of 2019 and the fourth quarter of 2021 was approximately 12%. Preliminary full year 2021 instruments and accessories revenue increased by 26% to approximately $3.10 billion, compared with $2.46 billion for 2020, primarily driven by growth in da Vinci procedure volume. The compound annual growth rate between the full year of 2019 and the full year of 2021 was approximately 13%.
Fourth quarter 2021 da Vinci procedures increased approximately 19% compared with the fourth quarter of 2020. The fourth quarter of 2020 reflected significant disruption caused by the COVID-19 pandemic, and the fourth quarter of 2021 reflected a COVID-19 resurgence later in the quarter, which also impacted our procedures. The compound annual growth rate between the fourth quarter of 2019 and the fourth quarter of 2021 was approximately 13%. In 2021, approximately 1,594,000 surgical procedures were performed with da Vinci Surgical Systems, an increase of 28% compared with approximately 1,243,000 surgical procedures performed with da Vinci Surgical Systems in 2020. The 2020 procedure results reflected significant disruption caused by the COVID-19 pandemic, and the 2021 procedure results reflected COVID-19 resurgences throughout the year, which also significantly impacted our procedures. The compound annual growth rate between the full year of 2019 and the full year of 2021 was approximately 14%.
Preliminary fourth quarter 2021 systems revenue increased by 28% to approximately $470 million, compared with $367 million in the fourth quarter of 2020. The compound annual growth rate between the fourth quarter of 2019 and the fourth quarter of 2021 was approximately 6%. Preliminary full year 2021 systems revenue increased by 44% to approximately $1.69 billion, compared with $1.18 billion in 2020. The compound annual growth rate between the full year of 2019 and the full year of 2021 was approximately 12%. The Company shipped 385 da Vinci Surgical Systems in the fourth quarter of 2021, compared with 326 systems in the fourth quarter of 2020. The fourth quarter 2021 system shipments included 143 shipped under operating lease and usage-based arrangements, compared with 120 systems in the fourth quarter of 2020. The Company shipped 1,347 da Vinci Surgical Systems in 2021, compared with 936 systems in 2020. The 2021 system shipments included 517 systems shipped under operating lease and usage-based arrangements, compared with 317 systems in 2020.
Impact of COVID-19 Pandemic
During 2020, da Vinci procedure volumes and system placements were significantly impacted by the COVID-19 pandemic, as healthcare systems around the world diverted resources to respond to COVID-19. During 2021, COVID-19 resurgences continued to impact da Vinci procedure volumes. The impact of the COVID-19 pandemic on the Company’s business has, and continues to, differ by geography and region. COVID-19 has had, and will likely continue to have, an adverse impact on the Company’s procedure volumes.
Commenting on the announcement, Intuitive CEO Gary Guthart said, “Our customers continued to choose our products in the fourth quarter during a difficult healthcare environment. As we enter 2022, we remain focused on supporting our customers and advancing our innovative ecosystem of platforms, learning, and services aimed at improving minimally invasive care.”
Additional unaudited preliminary revenue and procedure information has been posted to the Investor Relations section of the Intuitive website at: https://isrg.gcs-web.com/.
The Company is scheduled to present at the 2022 J.P. Morgan Healthcare Conference on January 12, 2022, at 12:45 p.m. PST. The Company is scheduled to report its fourth quarter 2021 results during a conference call on January 20, 2022, at which point the Company will discuss the 2021 financial results in more detail. Dial-in and webcast access information for both of these events are also available in the Investor Relations section of the Intuitive website.
Abbott Laboratories said Wednesday that it has received clearance from the U.S. Food and Drug Administration for its new heart mapping platform.
Abbott's EnSite X EP System with EnSite Omnipolar Technology creates detailed three-dimensional maps of the heart to help physicians better treat abnormal heart rhythms, or cardiac arrhythmias, the company said.
"These models provide a way to precisely identify areas that are causing problems, so physicians can better treat those abnormal heart rhythms, and preserve healthy tissue," said Mike Pederson, senior vice president of electrophysiology at Abbott.
Republicans on the House Oversight Committee have released several emails which suggest Dr. Anthony Fauci may have known that Covid-19 originated from a lab leak, and that it may have been "intentionally genetically manipulated."
"We write to request a transcribed interview of Dr. Anthony Fauci, Director, U.S. National Institute of Allergy and Infectious Diseases (NIAID). Excerpts of emails we are making public today (see enclosed Appendix I) reveal that Dr. Fauci was warned of two things: (1) the potential that COVID-19 leaked from the Wuhan Institute Virology (WIV) and (2) the possibility that the virus was intentionally genetically manipulated. It is imperative we investigate if this information was conveyed to the rest of the government and whether this information would have changed the U.S. response to the pandemic," reads the letter from Reps. James Comer and Jim Jordan to HHS Secretary Xavier Becerra.
The letter goes on to state that Fauci - despite claiming otherwise on multiple occasions - was in fact aware of the monetary relationship between NIAID, the NIH, EcoHealth Alliance and the Wuhan lab - by January 27, 2020. Fauci also knew that EcoHealth and NIAID worked together to craft a grant policy which would 'sidestep the gain-of-function moratorium at the time.'
"This allowed EcoHealth to complete dangerous experiments on novel bat coronaviruses - and with little oversight - that would have otherwise been blocked by the moratorium," the letter continues, adding that in January 2020, Fauci was also aware that EcoHealth was delinquent in submitting an annual progress report to NIAID, "presumably to hide a gain-of-function experiment conducted on infectious and potentially lethal bat coronaviruses."
The conference call
The letter references a February 1, 2020 conference call between Fauci, NIH head Collins, and 'at least eleven other scientists' who convened to discuss Covid-19.
"It was on this conference call that Drs. Fauci and Collins were first warned that COVID-19 may have leaked from the WIV and, further, may have been intentionally genetically manipulated. Again, it is unclear if either Dr. Fauci or Dr. Collins ever passed these warnings along to other government officials or if they simply ignored them."
Three days after the call, four participants authored a paper entitled "The Proximal Origin of SARS-CoV-2," of which Fauci and Collins were sent drafts. The authors, who had previously expressed concern over a lab-leak and genetic manipulation, suddenly abandoned that theory to insist the new virus had a natural origin.
Meanwhile, on April 16, 2020, Collins emailed Fauci to express dismay that the Nature Medicine article which they saw prior to publication (and were given the opportunity to edit), did not quash the lab leak hypothesis. Collins asked Fauci if the NIH could do more to "put down" the lab leak hypothesis. The next day, Fauci cited the paper from the White House podium "likely in an effort to further stifle the hypothesis that COVID-19 leaked from the WIV."
Questions
The House GOP letter then asks a series of questions.
Rather than be transparent with the Committee, HHS and NIH continue to hide, obfuscate, and shield the truth. By continuing to refuse to cooperate with our request, your agencies are choosing to hide information that will help inform the origins of the ongoing pandemic, prevent future pandemics, respond to future pandemics, inform the United States’ current national security posture, and restore confidence in our public health experts. HHS and NIH’s continued obstruction is likely to cause irreparable harm to the credibility of these agencies. The emails released today raise significant questions, including but not limited to:
1. Did Drs. Fauci or Collins warn anyone at the White House about the potential COVID-19 originated in a lab and could be intentionally genetically manipulated?
2. If these concerns were not shared, why was the decision to keep them quiet made?
3. What new evidence, if any, came to light about COVID-19 between February 1, 2020 and February 4, 2020 to alter the belief it originated in a lab?
4. Did Drs. Fauci or Collins edit the Nature Medicine paper entitled “The Proximal Origin of SARS-CoV-2”?
5. Would having this knowledge earlier have benefitted either vaccine or treatment development?
6. By February 1, 2020, were Drs. Fauci or Collins aware of the State Department’s warnings about WIV safety?
7. Would this warning have changed the early response to the COVID-19 pandemic?
Update (1505ET): As more and more information pours out of theProject Veritas leaked military documents, there appears to be a damning section insupport of Ivermectinas a Covid-19 treatment.
"Ivermectin (identified as curative in April 2020) works throughout all phases of illness because it both inhibits viral replication and modulates the immune response."
Project Veritas has obtained military documents hidden on a classified system [HERE – and HERE – and HERE] showing how EcoHealthAlliance approached DARPA in March 2018, seeking funding to conduct gain of function research of bat borne coronaviruses.
The proposal, named Project Defuse, was rejected by DARPA over safety concerns and the notion that it violated the gain of function research moratorium. However, according to the documents, NIAID, under the direction of Dr. Fauci, went ahead with the research in Wuhan, China and at several sites across the U.S.
[ZH - and just today, Twitter banned Project Veritas' Eric Spracklen...]
[WASHINGTON, D.C. – Jan. 10, 2022] Project Veritas has obtained startling never-before-seen documents regarding the origins of COVID-19, gain of function research, vaccines, potential treatments which have been suppressed, and the government’s effort to conceal all of this.
The documents in question stem from a report at the Defense Advanced Research Projects Agency, better known as DARPA, which were hidden in a top-secret shared drive.
DARPA is an agency under the U.S. Department of Defense in charge of facilitating research in technology with potential military applications.
Project Veritas has obtained a separate report to the Inspector General of the Department of Defense written by U.S. Marine Corp Major, Joseph Murphy, a former DARPA Fellow.
The report states that EcoHealth Alliance approached DARPA in March 2018, seeking funding to conduct gain of function research of bat borne coronaviruses. The proposal, named Project Defuse, was rejected by DARPA over safety concerns and the notion that it violates the basis gain of function research moratorium.
According to the documents, NIAID, under the direction of Dr. Fauci, went ahead with the research in Wuhan, China and at several sites across the U.S. (read more)
Here’s my answer to the question posed by James O’Keefe.
In the original pdf guidance for the 2014 research pause of into weaponization of SARS viruses there was an important footnote [LINK]:
[FN¹ SOURCE – U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses – pdf, page 2 – October 17, 2014]
Timeline:
♦ October 17, 2014 – U.S. funding of SARS to create a biological weapon was paused due to the extreme risk of a pandemic. However, the pause allowed agencies within the U.S. government to continue funding if they determined “the research is urgently necessary to protect the public health or national security.” [LINK]
♦ 2014 through 2020 the Pentagon continued funding research in Wuhan, China. Fear of discovery would explain why many top officials in the U.S. Defense Department were against the Trump administration [with increased severity after the COVID pandemic began]. [LINK]
♦ May 2016 – [An Election Year] – “after thorough deliberation and extensive input from domestic and international stakeholders, the NSABB [National Science Advisory Board for Biosecurity] issued its recommendations. NSABB’s central finding was that studies that are expected to enhance Potential Pandemic Pathogen (PPP) have potential benefits to public health but also entail significant risks. NSABB recommended that such studies warranted additional scrutiny prior to being funded.” Anthony Fauci is on the NSABB.
♦ January 9, 2017 – [Four Days after the Susan Rice Oval Office meeting with Obama, Biden, Comey, et al] – The Obama Administration re-authorizes funding for the creation of SARS biological weapons. “Adoption of these recommendations will satisfy the requirements for lifting the current moratorium on certain life sciences research that could enhance a pathogen’s virulence and/or transmissibility to produce a potential pandemic pathogen (an enhanced PPP).“ [LINK]
Given the workarounds, exceptions and plausible deniability for the consequences, built into the original moratorium guidance in 2014, the defense department was operationally permitted to keep funding the biological weapons research in Wuhan, China. The 2014 ban was a funding moratorium in name only; however, it appears the funding for U.S. research in North Carolina was stopped.
What was reauthorized in 2017, just before President Trump took office, was the need to use “national security” as an excuse to continue the research. It also appears funding of SARS as a biological weapon inside the U.S. (North Carolina) was now permitted again.
If you accept that the Pentagon would never spend to develop a biological weapon in China (Wuhan Lab) unless they already had developed that weapon on their own (North Carolina Lab), then the question about the release of that weapon starts to take shape.
Remember, the State Department was looking into the origin until Joe Biden shut them down and redirected the goal to the Intelligence Community. In essence, Biden handed the mission to the Fourth Branch of Government. Not surprisingly, after a few months the IC said their results were “inconclusive.”
♦ [Excerpt] – […] In one State Department meeting, officials seeking to demand transparency from the Chinese government say they were explicitly told by colleagues not to explore the Wuhan Institute of Virology’s gain-of-function research, because it would bring unwelcome attention to U.S. government funding of it.
In an internal memo obtained by Vanity Fair, Thomas DiNanno, former acting assistant secretary of the State Department’s Bureau of Arms Control, Verification, and Compliance, wrote that staff from two bureaus, his own and the Bureau of International Security and Nonproliferation, “warned” leaders within his bureau “not to pursue an investigation into the origin of COVID-19” because it would “‘open a can of worms’ if it continued.”
[…] In late March, former Centers for Disease Control director Robert Redfield received death threats from fellow scientists after telling CNN that he believed COVID-19 had originated in a lab. “I was threatened and ostracized because I proposed another hypothesis,” Redfield told Vanity Fair. “I expected it from politicians. I didn’t expect it from science.” (read more)
♦ Washington (CNN) – “President Joe Biden’s team shut down a closely-held State Department effort launched late in the Trump administration to prove the coronavirus originated in a Chinese lab over concerns about the quality of its work, according to three sources familiar with the decision.
The existence of the State Department inquiry and its termination this spring by the Biden administration — neither of which has been previously reported — comes to light amid renewed interest in whether the virus could have leaked out of a Wuhan lab with links to the Chinese military. The Biden administration is also facing scrutiny of its own efforts to determine if the Chinese government was responsible for the virus.
♦ “On Wednesday, Biden issued a statement that he has directed the US intelligence community to redouble its efforts in investigating the origins of the Covid-19 pandemic and report back to him in 90 days.” (LINK)
♦ [WASHINGTON DC] – The intelligence community failed to conclusively identify the origin of the coronavirus following a 90-day investigation ordered by President Biden, but experts are divided on why.
A report by the Office of the Director of National Intelligence (ODNI) found that officials were unable to rule whether the virus escaped from a lab or spread to humans through an infected animal. But the ultimate conclusion reached by the $85 billion-a-year community was that it would be unable to pinpoint the origin of the virus if China didn’t fully cooperate. (LINK)