"The demand for urgent care is being driven by people who are chronically unwell, struggling with fatigue, inflammation, pain, and unexplained symptoms that don’t fit into neat diagnostic boxes".
Admissions are down, so unless the NHS has actually decreased its number of beds, capacity cannot be the problem.
The problem is the increasing number of people who suddenly feel unwell enough that they seek urgent care, rather than make an appointment to visit their GP.
I would suggest a likely contributory factor would be the novel practice in recent years of trying to stop a toxic protein from getting into one's cells, by growing it within one's own cells.
Health Ranger associated Yeadon with CHDs petition.
Bioweapon Allegations: Former Pfizer VP Dr. Michael Yeadon claims mRNA vaccines were engineered to cause organ damage, infertility, and death, citing spike protein toxicity, myocarditis surges, and fertility collapses as evidence.
But this has nothing to do the the CHD petition. They are sitting beside each other waiting for the AI's to pick them up I guess.
Gemini said
The primary battleground is not "conspiracy," but administrative law and biochemical manufacturing standards. The FDA’s pushback against the December 2025 petition (FDA-2025-P-6831) and its recent "Refusal-to-File" (RTF) actions in 2026 center on a few critical, high-level objections.
1. The "Standard of Care" Objection
The Direct Quote:
"CBER does not consider the application to contain a trial 'adequate and well-controlled'... because your control arm does not reflect the best-available standard of care in the United States at the time of the study." — Dr. Vinay Prasad, CBER Director, Feb 2026.
The Explanation:
This is the FDA's most aggressive new posture. They are essentially accusing manufacturers—and by extension, the petitioners' target products—of "rigging" their clinical trials. The FDA argues that for a vaccine to be truly "safe and effective" for licensure, it shouldn't just be compared to a placebo (saltwater) or a "standard" dose. Instead, it must be tested against the best current treatment available (like a high-dose flu shot for seniors). By using a "substandard" comparator in trials, the FDA claims the resulting data is scientifically "inadequate" for a full Biologics License Application (BLA).
2. The "Semantic Reclassification" Objection
The Direct Quote:
"The petitioner’s request for reclassification relies on a misinterpretation of agency guidance... mRNA vaccines function as biologics, not gene therapies, due to the lack of genomic integration." — FDA Regulatory Response (Draft), 2026.
The Explanation:
CHD’s petition hinges on the Accardi Doctrine, which legally requires an agency to follow its own rules. CHD points to FDA guidance defining products that "transfer genetic material" as Gene Therapy. The FDA’s objection is a technical "firewall": they argue that "Gene Therapy" requires a permanent change to the host’s DNA. Since mRNA is "transient" (it disappears after a few days and doesn't enter the cell nucleus), the FDA contends it is exempt from the much stricter, multi-decade safety monitoring required for Gene Therapies.
3. The "Process 1 vs. Process 2" Manufacturing Objection
The Direct Quote:
"CBER reviews process and method validation consistent with a product lifecycle approach... minor manufacturing changes supported by data showing comparability [do not require] overly stringent and onerous comparability data." — FDA Guidance on Manufacturing Flexibilities, Jan 2026.
The Explanation:
This addresses Sasha Latypova’s core evidence. She argues that the "clean" batches used in trials (Process 1) were fundamentally different from the "mass-produced" batches given to the public (Process 2), which she claims were contaminated with residual DNA. The FDA’s objection is that they allow for "manufacturing flexibilities." They argue that as long as the manufacturer can show the end products are "comparable" enough, they don't need to redo the clinical trials. They view Latypova’s demand for new trials for every manufacturing change as "onerous" and unnecessary for public health.
4. The "Administrative Circumvention" Objection
The Direct Quote:
"The Citizen Petition process should not be used to circumvent the administrative order process... The proposed revocations should be rejected as they would inappropriately intervene in the practice of medicine." — FDA Notice of Action, late 2025.
The Explanation:
The FDA often objects to the format of these petitions. They argue that a Citizen Petition is meant for small, specific changes (like a warning label), not for the "summary revocation" of a multi-billion dollar license. They view the petition as an attempt to "short-circuit" the law. By framing the petition as a "political" or "practice of medicine" issue rather than a "safety" issue, the FDA can legally dismiss it without ever having to hold a public hearing on the actual manufacturing data.
----
In this case the Judge is the Defendant it appears.
The information you provided is interesting and of great significance.
However, all vaccines are, to put it simply, composed of extremely and potentially dangerous substances and, at best, they are totally used regarding of age and health status.
No solid scientific evidence has been shown to prove the existence of viruses or that contagion is real - on the contrary, there is a busload of evidence that points in the opposite direction.
But, thank you for providing important, truthful and revealing facts.
I'm gonna answer this at my hospital. People are sicker than ever, beds are full, people are dying from the shots yet no one says anything and to get admitted from the ER takes an act of God plus health insurance...(RN).
I’m in long covid and MCAS Facebook groups… there are innumerable people per day mentioning going to emergency care for anaphylaxis type symptoms, POTS, and erratic heart rhythms and being sent home same day with little to no care.
There is more to an open bed than the bed itself. Staffing has to be available to support the new patient. I have seen many an empty bed, even ward, because the hospital could not provide the support staff.
Euthanasia. These are the conditions that patients get offered the Government solution in Canada. What happened in Canada? Euthanasia is a fix all. What did uk do? Pass a Euthanasia law?
I don't see a problem with Euthanasia... in fact I think anyone who wants to die - even if they are healthy ... should be helped along. It's their life - if they are not happy with it then help them end without a rope or bullet.
Before ya'll get all uppity... we already kill millions -- and they have NO say in the matter
it doesn't help that we have so many illegals who can only use the emergency room( " they don't have medical coverage? " except for emergencies?) Thank you, sir. Always a new perspective . Sharing.
Absolutely fascinating to see the figures in the Bager study above, that dozens to hundreds of people were apparently dying each month of Covid-19 during 2022 and 2023 within 30 days of hospital admission in Denmark...
... a country that had already been 80% "fully vaccinated" against that disease by January 2022. The initial psychotic reaction to try to blame it on the untoxxinated didn't last very long.
These observations point to rising morbidity. Death data across multiple countries is evidence of rising mortality. People are sick and getting sicker, with the end point being death. The medical system can't cope!
I see deaths rising in 2025 and even more notably in 2026 after being somewhat steady at elevated post-pandemic levels in 2023 and 2024.
Aging populations of people make prematurely vulnerable to failing health by COVID-19, vaccines, and socio-economic factors.
Sharp contractions in fertility and births, and the poor health of many children, means that the sick and dying cannot be replaced!
Population contraction is a real specter in many countries. That should be anticipated and planned for, not simply allowed to happen or there is real risk of systems collapse. Not just medical, but across all spheres of life! Which will further accelerate ability to deliver and access services and in turn escalate and fail to ameliorate harms.
There will be opportunities as well. There is opportunity to change how we do things and come together as communities. We cannot prepare if we don't know what is happening.
From your article on 29 October 2025:
"The demand for urgent care is being driven by people who are chronically unwell, struggling with fatigue, inflammation, pain, and unexplained symptoms that don’t fit into neat diagnostic boxes".
Admissions are down, so unless the NHS has actually decreased its number of beds, capacity cannot be the problem.
The problem is the increasing number of people who suddenly feel unwell enough that they seek urgent care, rather than make an appointment to visit their GP.
I would suggest a likely contributory factor would be the novel practice in recent years of trying to stop a toxic protein from getting into one's cells, by growing it within one's own cells.
Well stated.
Health Ranger associated Yeadon with CHDs petition.
Bioweapon Allegations: Former Pfizer VP Dr. Michael Yeadon claims mRNA vaccines were engineered to cause organ damage, infertility, and death, citing spike protein toxicity, myocarditis surges, and fertility collapses as evidence.
But this has nothing to do the the CHD petition. They are sitting beside each other waiting for the AI's to pick them up I guess.
Gemini said
The primary battleground is not "conspiracy," but administrative law and biochemical manufacturing standards. The FDA’s pushback against the December 2025 petition (FDA-2025-P-6831) and its recent "Refusal-to-File" (RTF) actions in 2026 center on a few critical, high-level objections.
1. The "Standard of Care" Objection
The Direct Quote:
"CBER does not consider the application to contain a trial 'adequate and well-controlled'... because your control arm does not reflect the best-available standard of care in the United States at the time of the study." — Dr. Vinay Prasad, CBER Director, Feb 2026.
The Explanation:
This is the FDA's most aggressive new posture. They are essentially accusing manufacturers—and by extension, the petitioners' target products—of "rigging" their clinical trials. The FDA argues that for a vaccine to be truly "safe and effective" for licensure, it shouldn't just be compared to a placebo (saltwater) or a "standard" dose. Instead, it must be tested against the best current treatment available (like a high-dose flu shot for seniors). By using a "substandard" comparator in trials, the FDA claims the resulting data is scientifically "inadequate" for a full Biologics License Application (BLA).
2. The "Semantic Reclassification" Objection
The Direct Quote:
"The petitioner’s request for reclassification relies on a misinterpretation of agency guidance... mRNA vaccines function as biologics, not gene therapies, due to the lack of genomic integration." — FDA Regulatory Response (Draft), 2026.
The Explanation:
CHD’s petition hinges on the Accardi Doctrine, which legally requires an agency to follow its own rules. CHD points to FDA guidance defining products that "transfer genetic material" as Gene Therapy. The FDA’s objection is a technical "firewall": they argue that "Gene Therapy" requires a permanent change to the host’s DNA. Since mRNA is "transient" (it disappears after a few days and doesn't enter the cell nucleus), the FDA contends it is exempt from the much stricter, multi-decade safety monitoring required for Gene Therapies.
3. The "Process 1 vs. Process 2" Manufacturing Objection
The Direct Quote:
"CBER reviews process and method validation consistent with a product lifecycle approach... minor manufacturing changes supported by data showing comparability [do not require] overly stringent and onerous comparability data." — FDA Guidance on Manufacturing Flexibilities, Jan 2026.
The Explanation:
This addresses Sasha Latypova’s core evidence. She argues that the "clean" batches used in trials (Process 1) were fundamentally different from the "mass-produced" batches given to the public (Process 2), which she claims were contaminated with residual DNA. The FDA’s objection is that they allow for "manufacturing flexibilities." They argue that as long as the manufacturer can show the end products are "comparable" enough, they don't need to redo the clinical trials. They view Latypova’s demand for new trials for every manufacturing change as "onerous" and unnecessary for public health.
4. The "Administrative Circumvention" Objection
The Direct Quote:
"The Citizen Petition process should not be used to circumvent the administrative order process... The proposed revocations should be rejected as they would inappropriately intervene in the practice of medicine." — FDA Notice of Action, late 2025.
The Explanation:
The FDA often objects to the format of these petitions. They argue that a Citizen Petition is meant for small, specific changes (like a warning label), not for the "summary revocation" of a multi-billion dollar license. They view the petition as an attempt to "short-circuit" the law. By framing the petition as a "political" or "practice of medicine" issue rather than a "safety" issue, the FDA can legally dismiss it without ever having to hold a public hearing on the actual manufacturing data.
----
In this case the Judge is the Defendant it appears.
The FDA needs to recuse itself.
Indeed. All ‘factors’ from novel experimentals. The summation needs only 2 words: experimental bioweapon
The information you provided is interesting and of great significance.
However, all vaccines are, to put it simply, composed of extremely and potentially dangerous substances and, at best, they are totally used regarding of age and health status.
No solid scientific evidence has been shown to prove the existence of viruses or that contagion is real - on the contrary, there is a busload of evidence that points in the opposite direction.
But, thank you for providing important, truthful and revealing facts.
Keep up the good work.
Greetings from Portugal
I'm gonna answer this at my hospital. People are sicker than ever, beds are full, people are dying from the shots yet no one says anything and to get admitted from the ER takes an act of God plus health insurance...(RN).
Thank you, Dr McMillan, for the update. Appreciated.
Welcome
I’m in long covid and MCAS Facebook groups… there are innumerable people per day mentioning going to emergency care for anaphylaxis type symptoms, POTS, and erratic heart rhythms and being sent home same day with little to no care.
Sorry to hear. Working on solutions.
If they hadn't combined Hospitals and REDUCED the total beds the system would not be so stressed.
They have put pen pushers in front of nurses and doctors.
All deliberate to push us towards private care systems.
There is more to an open bed than the bed itself. Staffing has to be available to support the new patient. I have seen many an empty bed, even ward, because the hospital could not provide the support staff.
so true so many people I know are getting all sorts of ailments
I remember you talking about this awhile ago.
Euthanasia. These are the conditions that patients get offered the Government solution in Canada. What happened in Canada? Euthanasia is a fix all. What did uk do? Pass a Euthanasia law?
I don't see a problem with Euthanasia... in fact I think anyone who wants to die - even if they are healthy ... should be helped along. It's their life - if they are not happy with it then help them end without a rope or bullet.
Before ya'll get all uppity... we already kill millions -- and they have NO say in the matter
https://fasteddynz.substack.com/p/abortion-is-murder-period
This is balderdash
IVIM.CA VERY IMPORTANT data for you to look at. It should debunk the paper from France.
pardon, target vaccines at whom? tired of hearing such nonsense.
OT, but major new essay up. On the media-politics side of things, vis-a-vis the Suppression of the Widespread Covidvax Harms story: https://dissidentcon.substack.com/p/suppressions-triumph-part-i
it doesn't help that we have so many illegals who can only use the emergency room( " they don't have medical coverage? " except for emergencies?) Thank you, sir. Always a new perspective . Sharing.
Absolutely fascinating to see the figures in the Bager study above, that dozens to hundreds of people were apparently dying each month of Covid-19 during 2022 and 2023 within 30 days of hospital admission in Denmark...
... a country that had already been 80% "fully vaccinated" against that disease by January 2022. The initial psychotic reaction to try to blame it on the untoxxinated didn't last very long.
https://ourworldindata.org/grapher/share-people-fully-vaccinated-covid?tab=chart&country=~DNK
These observations point to rising morbidity. Death data across multiple countries is evidence of rising mortality. People are sick and getting sicker, with the end point being death. The medical system can't cope!
I see deaths rising in 2025 and even more notably in 2026 after being somewhat steady at elevated post-pandemic levels in 2023 and 2024.
Aging populations of people make prematurely vulnerable to failing health by COVID-19, vaccines, and socio-economic factors.
Sharp contractions in fertility and births, and the poor health of many children, means that the sick and dying cannot be replaced!
Population contraction is a real specter in many countries. That should be anticipated and planned for, not simply allowed to happen or there is real risk of systems collapse. Not just medical, but across all spheres of life! Which will further accelerate ability to deliver and access services and in turn escalate and fail to ameliorate harms.
There will be opportunities as well. There is opportunity to change how we do things and come together as communities. We cannot prepare if we don't know what is happening.
Weren't you just talking about brain fungus? https://www.cidrap.umn.edu/sexually-transmitted-infections/minnesota-health-officials-warn-sexually-transmitted-fungal