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FDA Approves First Dietary Supplement under New Drug Application with the Indication of Serious or Life-Threatening Illnesses

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Pharmacology & Pharmacy 2022年第12期13卷 529-544页

作者： Huu S. Tieu Martin F. Loeffler golden sunrise nutraceutical Inc. Porterville USA

Background: Research began on botanical/herbal organisms to study plant cells. The idea behind this was that plant cells have basic similar actions as do animal cells (i.e., both are Eukaryotic cells). These cells can show what activity is produced from the Technology/Innovation behind ImunStem, without risk to animals or humans, and still retrieve data to verify the theory. By using plants and studying plant cell activity, then later comparing plant cell, animal cells, and human cell responses, it thus shows activity for all cell structures. The activity was also studied from patients taking ImunStem for the indication of Serious or Life-threatening conditions or diseases. Patient medical report results showed an overall improvement in bodily function as blood report results were compared. Patients that were administered ImunStem showed improvement in their overall health and patients with chronic disease had reduced pain as ImunStem was administered over time. The pain was reduced because the body was in the healing process and a reduction in inflammation would occur during healing and the patient’s health would improve. ImunStem was produced based on the theory that the product could rejuvenate the cell and bring the cell back to a homeostasis balance. This balance to the cell (through nutrition) can give the surrounding cells a homeostasis balance that may heal cells and tissues in the body. It is believed that the function of a Quantum Wave effect is explained through the discipline of Quantum Mechanics. The Quantum Wave may disrupt the subatomic particles that provide adhesion to allow the product through the cell wall and move to its target location. In Quantum Mechanics, particles have wavelike properties. The Schrödinger equation, for example, governs how these waves behave. Methods: Administration of ImunStem was given to patients in a life-threatening situation where no standard acceptable treatment was available and in which there was not sufficient

关键词： FDA Serious or Life-Threatening Conditions or Diseases Immunology Dietary Supplements Quantum Mechanics Herbal/Botanical

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Huu S. TIEU Request for FDA to Establish Regenerating Human Cells as Law on December 13, 2016 President Barack H. Obama Signed the 21st Century CURES Act into FDA Regulation and Law

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Open Journal of Regenerative Medicine 2022年第3期11卷 55-62页

作者： Huu S. Tieu Martin F. Loeffler Edgar A. Ayala golden sunrise nutraceutical Inc. Porterville USA

Background and Aims: On November 24, 2009, Huu S. TIEU and golden sunrise Pharmaceutical, Inc. (golden sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administration (FDA). In the review and evaluation, it was requested by golden sunrise designated the new indications for this application under Serious or Life-threatening conditions or diseases. Discussions followed with the FDA, Huu S. TIEU, and golden sunrise for FDA approval on new products and new indications on existing new Medical Technology and Innovation. It was agreed in Year-2015 that the FDA would take the request for new indications to the United States Congress to establish into FDA regulation and law. At that time the following was the FDA Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided that such emergency use is reported to the Institutional Review Board within five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. There has been no funding to the authors for the writing or publication of this article. Methods: It was requested by Huu S. TIEU and golden sunrise in documents given to the FDA to have Serious or Life-threatening conditions or diseases indication be recognized by law. On August 08, 2015, the FDA responding to this request took the documentation produced by golden sunrise to the United States Congress on behalf of golden sunrise and Huu S. TIEU. This article encompasses the FDA regulatory method as well as the discussion and results of the establishment of the FDA and the 21st Century Cures Act. Results: On December 13, 2016, H.R.34—114th United States Congress (2015-2016) 21st Century CURES Act was signed into law by President Barack H. Obama which included the Serious or Life-threatening indication to be written into the CURE

关键词： Huu S. TIEU Request for FDA to Establish Regenerating Human Cells as Law on December 13 2016 President Barack H. Obama Signed the 21st Century CURES Act into FDA Regulation and Law

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Tiêu Equation Experimentation of Understanding by Energy Transfer Quantum Mechanics

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Natural Science 2023年第3期15卷 91-102页

作者： Huu S. Tieu Martin F. Loeffler golden sunrise nutraceutical Inc. Porterville USA

Background: The Tiêu equation has a ground roots approach to the process of Quantum Biology and goes deeper through the incorporation of Quantum Mechanics. The process can be measured in plant, animal, and human usage through a variety of experimental or testing forms. Animal studies were conducted for which, in the first day of the study all the animals consistently gained dramatic weight, even as a toxic substance was introduced as described in the introduction of the paper to harm animal subjects which induced weight loss through toxicity. Tests can be made by incorporating blood report results. Human patients were also observed to show improvement to their health as administration of the substance was introduced to the biological mechanism and plants were initially exposed to the substance to observe results. This is consistent with the Tiêu equation which provides that wave function is created as the introduction of the substance to the biological mechanism which supports Quantum Mechanics. The Tiêu equation demonstrates that Quantum Mechanics moves a particle by temperature producing energy thru the blood-brain barrier for example. Methods: The methods for the Tiêu equation incorporate animal studies to include the substance administered through laboratory standards using Good Laboratory Practices under Title 40 C.F.R. § 158. Human patients were treated with the substance by medical professionals who are experts in their field and have knowledge to the response of patients. Plant applications were acquired for observation and guidance of ongoing experiments of animals’ representative for the biologics mechanism. Results: The animal studies along with patient blood testing results have been an impressive line that has followed the Tiêu equation to consistently show improvement in the introduction of the innovation to biologic mechanisms. The mechanism responds to the substance by producing energy to the mechanism with efficient effect. For plant observations, p

关键词： Tiêu Equation Experimentation of Understanding by Energy Transfer Quantum Mechanics golden sunrise nutraceutical Huu S. TIȆu Schrödinger Equation Quantum Mechanics Life Is Quantum Biology

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Life Is Quantum Biology Effects Explained from the Schrödinger Equation, Serious or Life-Threatening Conditions or Diseases, and COVID-19 Results

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Journal of Biosciences and Medicines 2022年第10期10卷 164-172页

作者： Huu S. Tieu Martin F. Loeffler golden sunrise nutraceutical Inc. Porterville USA

Background: A plant based approach was undertaken to ascertain the efficacy of the Technology/Innovation of a new medical Technology based on similar activity to the circulatory system of plants. Basic Technology formulations were introduced into plant structures to evaluate the responses for cell division and plant growth which ultimately lead to the final product. This Technology/Innovation transforms and enhances common botanical/herb products such that they can be used to treat COVID-19 infection and Serious or Life-threatening conditions or diseases. They can restore the diseased cell’s abnormal metabolism to homeostasis and return it to normal function by slowing or reversing the cell’s malfunctioning metabolism, or in other words, slowing or reversing the disease process. Methods: A systematic treatment for COVID-19 infection and Serious or Life-threatening illness in patients is based on theories of traditional Chinese medicine. The Technology/Innovation is developed as dietary supplement products for treatment of Serious or Life-threatening conditions or diseases. Results: The results consist of over one hundred Serious or Life-threatening patient medical records. The U.S. Food and Drug Administration (FDA) reviewed/evaluated/accepted the Technology/Innovation patient medical record results, which included fifty-four COVID-19 patients with Prioritized Review Expedited No.: 2020-2867 CR2020-2596 information on September 16, 2020 and twenty-seven cancer patients Cancer Survival Rate Results in (Table 1) with FDA Establishment Identification No.: 3012327979 information on March 25, 2019 as FDA-Regulated medical products and meet the requirement under FDA Significant Scientific Agreement standards.

关键词： Cellular Therapy COVID-19 Serious or Life-Threatening Conditions or Diseases Schrödinger Equation Blood-Brain Barrier Immunology

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Patient Quality-of-Life, Providers with Incentive Payments, Real-World Evidence, and Reducing Healthcare Costs through New Innovations

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Health 2023年第4期15卷 312-325页

作者： Huu S. Tieu Martin F. Loeffler golden sunrise nutraceutical Inc. Porterville USA

Background: Value-Based Care is a program that was created by Professor Michael E. PORTER and Elizabeth O. TEISBERG which has been modified for implementation over the last seventeen years. This new program is paid by Commercial Health Insurers (Insurance Companies) and Centers for Medicare and Medicaid Services (Medicare). This program incorporates the patients, doctors, Life Sciences Companies, Insurance Companies, Holistic practice, traditional Chinese medicine, etc. with alternative traditional treatments and therapies for Real-World Evidence based and value-based treatment customized to patients’ needs and the patients benefit. Methods: The program was proposed to achieve value for patients and an improved healthcare system which is especially needed to provide treatment for patients in Serious or Life-threatening conditions or diseases. The program will accurately measure the outcomes of patients and provide a wider choice of treatments that matter to patients, also to measure the cost that successful alternative treatments provide which may lower the cost to Medicare and Insurance Companies. Conclusion: The proposed and now implemented program is to achieve value for patients. golden sunrise nutraceutical (golden sunrise) provides a New Medical Innovation and treatment alternative to patients suffering from Serious or Life-threatening illnesses. By using golden sunrise Innovation and with the incorporation of Value-based Care patients will become the drivers or it could be said the patient Ambassadors of their own health. By incorporating golden sunrise Innovation, the doctors will have more diversity of treatments available for their patients. Payment should reflect value not volume, and the New Medical Innovation golden sunrise offers will help in reducing the costs to Insurance Companies accelerating the adoption of Value-Based Care.

关键词： golden sunrise nutraceutical Value-Based Care Life Is Quantum Biology Medicare for All

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Huu S. TIEU’s Predicting Outcome of Severe Acute Respiratory Syndrome (SARS) and Preparing the Treatment for COVID-19 (Coronavirus) and Other Viral Pandemics

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International Journal of Clinical Medicine 2023年第2期14卷 110-115页

作者： Huu S. Tieu Martin F. Loeffler golden sunrise nutraceutical Inc. Porterville USA

This project paper is to give a prediction for the future of other viral pandemics and to provide recommendations for preparing therapies that could help in the success of effective treatments and benefits for patients in life-threatening situations. The theory of prediction was proposed by Huu S. TIEU on March 25, 2019, and he hypothesized that any malfunctioning cell in the body could have a damaging effect. This paper discusses the prediction that Localized Oxygen Deprivation could be a contributing factor for a future epidemic or other viral pandemics that could affect body function. This paper is based on opinion and does not have sufficient evidence to support the claims made. Therefore, further in-depth study is needed to prove the findings. The author cites Hypoxia to support his idea, but he is not claiming that Hypoxia-Inducible Factor (HIF) has worked on his predictions. The author also tested a theory using cow blood curd for body function, but this test was not a structured test and the findings were not supported by other evidence. To further prove the idea or theory, further study into the subject should be conducted.

关键词： COVID-19 (Coronavirus) Severe Acute Respiratory Syndrome (SARS) Viral Pandemics Huu S. TIEU Life Is Quantum Biology

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