This is the best tl;dr I could make, original reduced by 84%. (I'm a bot)
> A team of scientists in the United Kingdom and the U.S. recently reported the discovery of pathological signs of Alzheimer's disease in dolphins, animals whose brains are similar in many ways to those of humans.
> The new finding in dolphins supports the research team's hypothesis that two factors conspire to raise the risk of developing Alzheimer's disease in dolphins.
> Together, the insight into the similarities between dolphins and humans has led us to hypothesize that Alzheimer's and diabetes are diseases not of old age but of a long post-fertility life span.
> Although dolphins live in water and humans live on Earth, dolphins and humans are very much alike in some key ways.
> As do humans, dolphins have a highly evolved brain development and a very complex social relationship.
> We believe this makes our findings in dolphins of both neuritic plaque and tangle pathology in dolphins all the more remarkable.
Summary Source | FAQ | Feedback | Top keywords: dolphin^#1 human^#2 Alzheimers^#3 brain^#4 disease^#5
Post found in /r/science, /r/marinebiology, /r/whales and /r/news.
NOTICE: This thread is for discussing the submission topic. Please do not discuss the concept of the autotldr bot here.
Hey SAVAges. Will be submitting this CP with the help of u/our-government-2127. Thank you to the neurologist, and Pharm D who assisted with the content.
The google doc contains the figures and photos.
https://docs.google.com/document/d/110xyXmbIubp08U6BiM1rJJG7efFe4UUHvF3HdayBDbc/edit?usp=sharing
November 16, 2021
Division of Dockets Management
Food and Drug Administration
Room 1061
5630 Fishers Lane
Rockville, MD 20857
VIA USPS
CITIZEN PETITION
This petition for administration action is submitted on behalf of the undersigned Petitioner pursuant to 21 C.F.R. § 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and Drugs (the "Commissioner") immediately expedite approval of the drug Simufilam pursuant 21 U.S. Code § 356 - Expedited Approval of drugs for serious or life-threatening diseases or conditions.
- ACTION REQUESTED
Petitioner is requesting the FDA for Accelerated Approval of Simufilam for the most significant unmet medical need in the United States of America.
- STATEMENT OF GROUNDS
📷
Artist William Utermohlen was diagnosed with AD (Alzheimer's disease) in 1995. In the figure above, he painted what he saw in the mirror. As William Utermohlen's Alzheimers progressed, his understanding of the world rapidly declined. From his last painting in 2000, we see that he spent the final seven years of his life incapable of seeing the world, effectively blind. He passed away in 2007.
This view of AD from a patient perspective is tragic and touching. It elicits anxiety for those of us with sound minds. What is it like to look into the mirror, unable to see one's own face for seven years? What else are they unable to see?
I review these weighty problems with the FDA to help frame my logic and construct a petition for why Simufilam must be expediently granted accelerated approval and advanced to phase 4 post-marketing surveillance based on the risk-benefit analysis below.
After reviewing the FDA's mission statement, I am operating on the premise that the FDA evaluates medications based on risk benefits.
- There is an overwhelming and urgent need ("An Unmet Medical Need")
- Simufilam has consistently reported an excellent safety and tolerability profile. (The risk)
- The cognitive data, by my judgment, is a treatment effec
Why is it so hard to figure out what is causing AD? What if BIIB, CRTX, SAVA and AVXL are all seeing part of the answer, and they are all right to some extent? Is this like the biblical parable of the blind men and the elephant?
Let’s see what we get if we put the leading theories on AD causes all together by examining disparate views of BIIB, CRTX, SAVA and AVXL.
The latest results from CRTX teach us that gingivitis is not the only cause of AD, but it appears to be one of the causes in cases where it shows up in the patient’s saliva. For those with systemic gingivitis, it now seems quite likely that these germs cross the BBB into the brain and cause some inflammation, and loss of cognition by damage done to neurons by the germs.
One of the most interesting parts of CRTX’s research includes the view that the brain evolved to protect against virus infections. According to CRTX’s research, a view supported by independent research (see cites of scientific articles on their website), the brain evolved to produce amyloid plaque at a time in history when it was important to human survival to fight off the deleterious effects of bacterial infections that got into the brain. So, suppose that is one of the reasons AD patients have the plaque in the first place, is because Gingivatis and other organisms get into aging brains as the BBB weakens with age. And, these germs (and/or viruses) trigger formation of plaques to block the germs and protect the brain. See "Good Amyloid, Bad Amyloid--What's the Difference" where the focus is on the different properties of Amyloids, and apparently the bad ones are binding to filamin A? (I'm not a scientist, so it would be appreciated if someone with more chemistry and a better understanding of SAVA's theory might comment here on the dual role of the anyloids.)
Ironically, the protective effect of the plaques may be countered by the process SAVA has discovered. That is, once the gingivitis (or other viruses or bacteria) cause the amyloid plaques to form, the next step happens when there are too many plaques, and (according to SAVA’s research), these the plaques bind to filamin A in a manner that causes the filamin A protein to misfold. Then altered filamin A signals cytokines and causes more inflammation AND it triggers a complex process that leads to phosphorylation of Tau.
When the tau protein is hyperphosphorylated, it induces the **breakdown of microtubules and the formation of insoluble aggregates of neurofibrillar
... keep reading on reddit ➡News Link: https://www.newsfilecorp.com/release/106715
Jackson Center, Pennsylvania--(Newsfile Corp. - December 6, 2021) - Halberd Corporation (OTC PINK: HALB) completed verification tests on elimination of Tumor Necrosis Factor-alpha (TNF-alpha) from synthetic cerebral spinal fluid (CSF). These tests confirmed virtually 100% elimination of TNF-alpha through Halberd's patented extracorporeal process, in combination with its patent-pending exposure to tuned laser irradiation. TNF-alpha is an inflammatory cytokine which has been identified as a major contributor to Alzheimer's Disease, and recently has been linked to PTSD/Chronic Traumatic Encephalopathy (CTE) and obesity.
Dr. Mitchell S. Felder, Chief Technology Officer of Halberd Corporation and a board certified attending neurologist remarked, "Our extracorporeal confirmation testing has shown a virtual 100% elimination of the TNF-alpha inflammatory cytokine from cerebral spinal fluid. This is a very important step in the regulation of the levels of this cytokine and could lead to a completely new approach to the treatment of Alzheimer's Disease, and perhaps other neurodegenerative diseases."
William A. Hartman, Halberd Corporation's Chairman, President & CEO, added, "The very promising results of these verification tests strengthens our resolve for finding effective treatments for PTSD, CTE and Alzheimer's Disease. We earlier reported on our successful elimination of Phosphorylated Tau from CSF, the primary building block of neurofibrillary tangles associated with Alzheimer's Disease, and Interleukin 6 (IL-6), another inflammatory cytokine associated with cognitive decline."
Hartman continued, "We are on target in our research program to address the elimination/regulation of several other inflammatory cytokines, proteins and glutamate from CSF which have been linked to the onset and progression of Alzheimer's disease, other neurodegenerative diseases and obesity. As a result of our research to date, we have homed in on the laboratory methodologies necessary to give us confidence that we will achieve our goals listed in the above test plan schedule. Along with our two major university partners, we will continue to focus on the eradication of the remaining pathogens from CSF and blood plasma related to Alzheimer's Disease, Parkinson's Disease, Lou Gehrig's Disease, Epilepsy and Obesity."
News Link: https://www.accesswire.com/666784/halberd-corporation-ceo-letter
JACKSON CENTER, PA / ACCESSWIRE / October 7, 2021 /
Greetings From The CEO And Staff At HALBERD CORPORATION! (OTC PINK:HALB)
This past quarter, Halberd has made some very significant and unparalleled achievements developing treatments for neurodegenerative diseases, such as PTSD/ CTE (Post Traumatic Stress Disorder/Chronic Traumatic Encephalopathy), Alzheimer's Disease, Parkinson's Disease, etc.
As reported in the last quarterly update, our research led us to investigate RF (Radio Frequency) and laser exposure, as the two patent-pending extracorporeal methods to eliminate targeted disease antigens. Our results this past quarter have been successful beyond our expectations. Our patented methodology has successfully eliminated Phosphorylated Tau from CSF (Cerebral Spinal Fluid). Phosphorylated Tau is believed to be the principal contributor to neurofibrillary tangles linked to Alzheimer's Disease related cognitive degeneration. Our scientists and research partners are confident that by eliminating this antigen, which we have accomplished in vitro, cognitive degeneration will be reduced, if not eliminated. Due to our laboratory success in eradicating Phosphorylated Tau, we are confident we will be successful in eliminating the remaining similar-sized target antigens and inflammatory cytokines linked to Alzheimer's Disease.
Halberd, through its research partner, Youngstown State University (YSU), successfully eliminated E.coli from buffer solution through RF and separately through laser radiation. This work continues, and will be expanding in the fourth quarter to evaluate elimination from bodily fluids. E.coli's presence in CSF is responsible for meningitis, and E.coli in blood is responsible for blood sepsis. Combined, these two afflictions are responsible for the deaths of an estimated 750,000 people each year in the US alone. Our scientists and research partners target the elimination of such deaths through our patented methodology.
In dealing with each disease state, we carefully calibrate the RF generator as well as the laser frequency regarding factors such as temperature, time exposure, particle size and other factors in order to ensure elimination of each disease antigen. Additionally, in each calibration, often disease specific,
... keep reading on reddit ➡https://www.omicsonline.org/open-access/vegetable-oil-the-real-culprit-behind-alzheimer8217s-disease-2161-0460-1000410-97144.html
> # Vegetable Oil: The Real Culprit behind Alzheimer’s Disease > > According to the WHO, treating and caring for people with dementia currently cost the world more than US$ 604 billion per year. Dementia is a disease which, although preventable, cannot be cured even by the modern medicine which is only palliative in nature. Dementia is not just a name of a disease. It means memory deficit, associated with symptoms which directly affect the quality of daily life and communication. Alzheimer’s disease is the most common form of dementia and possibly contributes to two-thirds of cases. In 2006, approximately 0.40% (absolute number 26.6 million) of the global population was estimated to be affected by Alzheimer’s disease, and its prevalence is expected to increase dramatically due to the aging global population. To date, cholinesterase inhibitors and a NMDA receptor antagonist have been most commonly utilized. However, they can insufficiently alter disease progression because the treatment usually starts after the synaptic loss and/or neuronal loss are completed. > > What is the real culprit behind Alzheimer’s disease? > > Especially, what is the exact mechanism of neuronal death? > > For almost half a century, it was believed that the cause of Alzheimer’s disease is the accumulation of the protein waste product, amyloid β in the brain. In the amyloid hypothesis, “senile plaque” (amyloid plaque) deposits in the brain, were supposed to gradually cause death of neurons, although the underlying molecular mechanism was not elucidated at all. This amyloid β hypothesis has been considered to be the most plausible explanation to date. However, this hypothesis does not fully explain all of the molecular cascades of Alzheimer’s disease, and is therefore heavily criticized. Many researchers began to voice doubts about the amyloid β hypothesis for the past decade, because of unbelievable PET images visualizing amyloid β in the living brain. In many patients with advanced Alzheimer’s disease, it’s been demonstrated that there is an extensive accumulation of amyloid β on PET. On the other hand, however, it’s also been shown that not a small number of elderly
... keep reading on reddit ➡Do your worst!
For context I'm a Refuse Driver (Garbage man) & today I was on food waste. After I'd tipped I was checking the wagon for any defects when I spotted a lone pea balanced on the lifts.
I said "hey look, an escaPEA"
No one near me but it didn't half make me laugh for a good hour or so!
Edit: I can't believe how much this has blown up. Thank you everyone I've had a blast reading through the replies 😂
JACKSON CENTER, PA / ACCESSWIRE / August 30, 2021 / Halberd Corp. (OTC PINK:HALB) provided an update on its Alzheimer's Disease eradication experimentation being conducted at Youngstown State University (YSU) and Arizona State University (ASU). Following standard scientific methodology, Halberd conducted two rounds of experimentation on Phosphorylated Tau, and the results were so astounding that the researchers want to conduct further replication tests prior to publication in scientific articles.
Bodily fluids treated with nanoparticles conjoined to specific antibodies attract and adhere to target disease antigens. These conjoined target antigens are subjected to laser emissive energy and to radio frequency waves in separate experiments. Halberd's initial target disease antigen, Phosphorylated Tau, is the primary building block of neurofibrillary tangles associated with the onset and progression of Alzheimer's Disease and other neurodegenerative diseases.
William A. Hartman, Halberd Corporation's Chairman, President & CEO, stated. "Once the replication testing is completed, our researchers will commence writing scientific articles on the technology and results. These tests and the scientific documents should be completed within the next several weeks. Testing on the other antigens associated with Alzheimer's Disease will commence at that time."
"Halberd's previous testing on E. Coli also yielded stunningly positive results, which are also being replicated prior to publication," Hartman concluded.
To get the latest news on Halberd's exciting developments, including our ongoing disease eradication accomplishments, subscribe by submitting this form.
(https://halberdcorporation.com/contact-us/)
It really does, I swear!
Author: u/equilateral_pupper(Karma: 3870, Created: Dec-2019).
$SAVA Monster Writeup Part 1: The Holy Grail of Pharmaceutical Research on r/WallStreetBets
PICTURES DETECTED: this DD post is better viewed in it's original post
If you would like to learn more about Simufilam trials, you can find patient information and trial sites here***.***
ALRIGHT RETARDS. This is the only $SAVA DD you'll need to read to understand what's going on with Alzheimer's research. I broke it up into 3 parts so your tiny attention spans would be able to read it over time. This is the first part, the part none of you think is necessary: Necessary Background Knowledge.
TLDR:
- Alzheimer’s is the most common form of dementia. 50 Million people worldwide and 5.8 Million in the United States have Alzheimer’s. There is no cure for Alzheimer’s and no way to definitively diagnose it. Untreated, people with Alzheimer’s always get worse.
- Current treatments (Aduhelm, Aricept) suck as they only slow the decline of patients with Alzheimer’s. Current diagnostic methods suck for Alzheimer’s because they involve a multistep process of family interviews, brain scans, or memory/cognition tests.
Alzheimer's Disease Fact Sheet
- Alzheimer's is the most common cause of dementia.
- Alzheimer's is a progressive disease, where dementia symptoms gradually worsen over a number of years. [source]
- The risk of Alzheimer's disease and other types of dementia increases with age. Alzheimer's is the sixth-leading cause of death in the United States. [source]
- 6.2 Million Americans have Alzheimer's. By 2050, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 12.7 million in the US. As the size and proportion of the U.S. population aged 65 and older continue to increase, the number of Americans with Alzheimer’s or other dementias will grow. This number will escalate rapidly in coming years, as the population of Americans age 65 and older is projected to grow from 55 million in 2019 to 88 million by 2050. The baby boom generation has already begun to reach age 65 and beyond, the age range
They’re on standbi
Pilot on me!!
Author: u/equilateral_pupper(Karma: 4029, Created: Dec-2019).
$SAVA Monster Writeup Part 2: The Drug is Simufilam on r/WallStreetBets
PICTURES DETECTED: this DD post is better viewed in it's original post
If you would like to learn more about Simufilam trials, you can find patient information and trial sites here.*** Part 1 is here.*
ALRIGHT RETARDS. This is the only $SAVA DD you'll need to read to understand how Simufilam works and the timeline of the research behind it. I broke it up into 3 parts so your tiny attention spans would be able to read it over time. This is the 2nd part, the part none of you want to read: The science behind Simufilam.
TLDR:
- Cassava Sciences is developing a new treatment for early to moderate stage Alzheimer’s called Simufilam and a diagnostic for Alzheimer’s Disease called SavaDX.
- Cassava Sciences finished Phase 2 trials in September 2020 and are currently running Open Label trials. Cassava Sciences is starting Phase 3 trials in September 2021. Once Phase 3 trials are over, the FDA will decide on whether or not to approve Simufilam. I believe Simufilam’s Phase 2 and Open Label trial data are extremely promising - patients who are currently testing it are actually getting better.
Cassava Sciences, Simufilam, and SavaDX
Cassava Sciences is a clinical stage pharmaceutical company. Its mission is to develop a treatment and diagnostic for Alzheimer’s disease.
Simufilam is a proprietary, small molecule oral (pill) drug that restores the normal shape and function of altered Filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Simufilam is protected by patents.
SavaDx is an investigational blood test to detect Alzheimer’s disease. SavaDX is protected by trade secrets.
Timeline of Drug Discovery and Research
- 2012 - Preclinical Studies [[1]](https://pubmed.ncbi.nlm.ni
Elevated levels of IL-6 are believed to be causal factors in PTSD, Chronic Traumatic Encephalopathy, & Alzheimer's Disease.
JACKSON CENTER, PA / ACCESSWIRE / November 1, 2021 / Halberd Corporation (OTC PINK:HALB) successfully eradicated 100% of IL-6 from synthetic cerebral spinal fluid (CSF) in preliminary testing. Through its patented extracorporeal process in combination with its patent-pending laser eradication process, IL-6 was virtually eliminated in as little as three minutes of laser radiation exposure. Elevated levels of IL-6 in CSF have been linked to various neurological disorders.
Dr. Mitchell S. Felder, Chief Technology Officer of Halberd Corporation and a board certified attending neurologist remarked, "The spontaneous production of IL-6 has been shown to be significantly higher in PTSD patients. This has directly correlated with PTSD symptom severity within the PTSD patient group. Practicing psychiatrists have stated they believe that the precisely controlled elimination of IL-6 and other inflammatory cytokines in CSF (cerebrospinal fluid) could be a very major breakthrough against PTSD and suicidal depression. Our recent breakthrough historic achievements with our university partners, position us to achieve that goal in medical practice."
William A. Hartman, Halberd Corporation's Chairman, President & CEO, added, "This is the next step in our march towards finding effective treatments for PTSD, CTE and Alzheimer's Disease. Previously, we successfully eliminated Phosphorylated Tau from CSF, the primary building block of neurofibrillary tangles associated with Alzheimer's Disease. Now that the quality problems have been eliminated from our purchased materials, we expect rapid progress ahead toward the final steps with these historic accomplishments.
"The next steps in our research program include verification testing related to IL-6 elimination from CSF, then moving on to eliminating Tumor Necrosis Factor - Alpha (TNF-α) and ultimately Glutamate from CSF. When we successfully eliminate these pathogens, we will approach the military for endorsement/support. Meanwhile, our longer term objective is to continue to focus on the eradication of th
... keep reading on reddit ➡
