Charade of new EUA Countermeasures continues...
Pemgarda, a monoclonal antibody for unknown version of covid receives and EUA
I can’t begin to describe how stupid this is, and any honest doctor can confirm this (if you find and honest doctor, ask them). Just a few years ago, if I told to my colleagues that a “prophylactic” monoclonal antibody will be greenlighted by the FDA based on a theoretical levels of an unvalidated theoretical surrogate marker of immune response (antibody titers), I would have been laughed out of the room. But those days are sadly over.
Monoclonal antibodies are inherently dangerous treatment options that during “normal” (actively profiteering but solidly pre-genocidal) stage of pharmaceutical industry were considered only for really serious, terminal conditions, and typically after other treatment approaches failed. Risks associated with mAbs include:
acute anaphylaxis, cytokine release syndrome (CRS) and serum sickness.
Acute anaphylaxis is a massive allergic reaction that can be life-threatening. Serum sickness happens when your body’s immune system attacks the antiserum, or a blood product containing the proteins that your healthcare team is using to try to help you. CRS is also called cytokine storm and can lead to organ damage.
According to the Endpoint News (who should be renamed into The Babylon Bee Pharma Edition):
On March 25, the FDA issued an emergency use authorization for Invivyd Pharma monoclonal antibody called Pemgarda “for Covid-19 prevention in high-risk immunocompromised patients”.
The drug is approved for patients 12 years and older who are unlikely to develop an adequate immune response from vaccination, aren’t currently infected with the virus or have been recently exposed to Covid-19.
Let’s read this again, slowly. This IV infusion of a biological-chemical substance is approved for people 12 yo+ who are:
NOT ill from covid (whatever that is);
Have NOT been exposed to anyone with covid (whatever that is), so are HIGHLY UNLIKELY to be ill with it;
…because they are “believed to be unlikely” to develop “adequate immune response from vaccination for covid”!
An additional stroke of genius includes the recommendation that these people still be vaccinated!
Here is the FDA letter of EUA Authorization.
Invivyd’s stock $IVVD closed 41% higher on Friday following the announcement.
Interestingly, major trade-up in stock happened much earlier, starting December 15, 2023. As we know, all DOD-funded “countermeasures” contracts stipulate that the development is completely open to the insider trading, because DARPA/BARDA personnel are copied on all material disclosure information exchanged between pharma and FDA (normally this info is strictly controlled as confidential due to the SEC public disclosure requirements). IMO, this is likely why the trades happened so much ahead of the March 25 announcement.
Jefferies analysts said Friday that they expect $300 million in sales of the therapy in 2024. Invivyd has a cash runway that’s set to last through the fourth quarter of this year. It had a cash balance of about $200 million at the end of 2023.
The analysts added that while the company did not quantify a “bolus of [patients] that may use Pemgarda right away,” Invivyd “does have a known database of [patients] with high unmet need and enthusiasm and could be the first adopters once commercial coverage is secured.”
This piece of news is exciting, and not because of the money involved. What this tells us - the EUA is issued 9 months before current PREP Act declaration for covid is set to expire (Dec 31, 2024) The EUA would not be valid afterwards. Therefore, we should fully expect that the Blob intends to continue extending “covid pandemic” declarations after the end of this year.
Finally, let’s review the Invivyd leadership - oh, look! This company is headed by Pfizer’s covid vax spawn, also ex-Novartis Countermeasures Bureau chief…
David Hering, M.B.A.
Chief Executive Officer & Director
Dave Hering, M.B.A. has served as our Chief Executive Officer and a member of the Board of Directors since July 2022. He joined Invivyd in June 2021 and previously served as our Interim Chief Executive Officer and as our Chief Operating Officer. Prior to joining the Invivyd team, Dave held a variety of senior leadership roles in his six years at Pfizer, where he led the preparation and launch of Pfizer’s COVID-19 vaccine in the United States, including the initial contracts with the U.S. government. He also led Pfizer’s partnership with Gavi, the Vaccine Alliance, which supplies millions of vaccines to the developing world. Before Pfizer, Dave held several roles at Novartis, most notably serving on the front lines of the H1N1 pandemic and leading the Medical Counter Measures group. He holds an M.B.A. from Harvard Business School and a B.S. in Operations Research and Industrial Engineering from Cornell University.
Tell your loved ones who have been gaslit by the system into believing they are “immunocompromised” that the Blob is on the prowl to finish them off via these layered insane strategies. My advice would be to fire the idiot doctors, take control of your own health via good nutrition, clean water, sunlight and good thoughts, good words and good deeds. Do not comply.
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Art for today: from the Dragon collection, watercolor.
The medical system has lost the plot. We are moving towards everyone being expected to just line up for random injections with unknown chemical slurries and the government will keep injecting cash into those doing the injecting and making the concoctions. Actually, I think we are there. It won’t be long until the hand of force enters.I feel so sorry for anyone who even has a doctor at this point.
The actual meaning of the abbreviation EUA is "Eradication Use Authorization".