TITLE:
FDA Approves First Dietary Supplement under New Drug Application with the Indication of Serious or Life-Threatening Illnesses
AUTHORS:
Huu S. Tieu, Martin F. Loeffler
KEYWORDS:
FDA, Serious or Life-Threatening Conditions or Diseases, Immunology, Dietary Supplements, Quantum Mechanics, Herbal/Botanical
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.13 No.12,
December
26,
2022
ABSTRACT: 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 time to obtain approval from the Institutional Review Board. Results: ImunStem showed positive medical results for patients with Serious or Life-threatening conditions or diseases, which prompted the US Food and Drug Administration (FDA) to move forward so patients could be provided treatment that was not otherwise available to them from their physicians/doctors. ImunStem was applied for and received its New Drug Application (NDA) No.: 204701 with the indication of Serious or Life-threatening conditions or diseases and National Drug Code (NDC) No.: 70642-001-01 on July 02, 2018. Golden Sunrise submitted an NDA application on January 07, 2013, November 05, 2018, and April 03, 2020 with a request for FDA Fast Track designation, Breakthrough Therapy designation, Accelerated Approval designation, and Priority Review program process are the pathway allowing the ImunStem product to receive acceptance by the FDA.