Quanta Inc (fka QNTA)

[falon]

Medolife RX is awaiting FDA approval.

Developing New Drugs

American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER).

The center's best-known job is to evaluate new drugs before they can be sold. CDER's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

FDA Approval: What it means


FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes:

Analysis of the target condition and available treatments—
FDA reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment landscape, which provide the context for weighing the drug’s risks and benefits. For example, a drug intended to treat patients with a life-threatening disease for which no other therapy exists may be considered to have benefits that outweigh the risks even if those risks would be considered unacceptable for a condition that is not life threatening.

Assessment of benefits and risks from clinical data—FDA reviewers evaluate clinical benefit and risk information submitted by the drug maker, taking into account any uncertainties that may result from imperfect or incomplete data. Generally, the agency expects that the drug maker will submit results from two well-designed clinical trials, to be sure that the findings from the first trial are not the result of chance or bias. In certain cases, especially if the disease is rare and multiple trials may not be feasible, convincing evidence from one clinical trial may be enough. Evidence that the drug will benefit the target population should outweigh any risks and uncertainties.

Strategies for managing risks—All drugs have risks. Risk management strategies include an FDA-approved drug label, which clearly describes the drug’s benefits and risks, and how the risks can be detected and managed. Sometimes, more effort is needed to manage risks. In these cases, a drug maker may need to implement a Risk Management and Mitigation Strategy (REMS).

Although many of the FDA’s risk-benefit assessments and decisions are straightforward, sometimes the benefits and risks are uncertain and may be difficult to interpret or predict. The agency and the drug maker may reach different conclusions after analyzing the same data, or there may be differences of opinion among members of the FDA’s review team. As a science-led organization, FDA uses the best scientific and technological information available to make decisions through a deliberative process.

Accelerated Approval

In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval. This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, the drug maker is required to conduct post-marketing clinical trials to verify and describe the drug’s benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.

Since the Accelerated Approval pathway was established in 1992, many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course. For example, many antiretroviral drugs used to treat HIV/AIDS entered the market via accelerated approval, and subsequently altered the treatment paradigm. A number of targeted cancer-fighting drugs also have come onto the market through this pathway.


How long does it take the FDA to approve a new drug?

Priority Review: During Priority Review, the FDA takes action on a new drug application within six months, compared to 10 months under standard review. These drugs receive higher priority because they can significantly improve the treatment, diagnosis, or prevention of serious conditions.Apr 13, 2020

How is drug evaluated before it is approved in the market?

A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.


They are nodding their heads in ASTONISHMENT


Why?

Medolife's Therapeutic Scorpion Peptide Proves Successful in Treating COVID-19 Patients in Dominican Republic Study


"The data proving the efficacy that Escozine has on a multitude of improved patient parameters is consistent with the rapid symptom relief I experienced while on site," said Dr. Annabelle Morgan, Cell and Developmental Biologist and one of Medolife's leading scientists. She noted, "What is even more astonishing is that 100% of patients tested negative for COVID-19 within 5-10 days of treatment."


"More importantly, all COVID-19 healthcare workers, including physicians and nurses, who took Escozine as a preventative, never tested positive" said Dr. Khalid Matalka, another leading scientist at Medolife, specializing in Cancer Therapy and Immunology. "The clinical trial results indicate that Escozine could be used as monotherapy or in combination with standard therapies against COVID-19, which will accelerate the healing from the virus. Besides, observations revealed that Escozine could be used as prevention from the COVID-19 infection."
https://ir.quantrx.com/news-events/press-releases/detail/46/medolifes-therapeutic-scorpion-peptide-proves-successful

Dr. Annabelle Morgan:

Nowadays, we don’t always equate science with healing. Science can save our lives (the greatest innovations have occurred inside of science labs), but it can also be driven by big business and controlled by government regulations. The story you are about to hear is one of scientific innovation, brilliant healing power, and how the two merged together. Welcome to the podcast, our first ever woman scientist, Dr. Annabelle Morgan! Dr. Annabelle has a PhD in Cell and Developmental Biology; she’s a mother of 4, and wife to Grammy Award winning reggae artist, Gramps Morgan. Dr. Annabelle is a cancer researcher, a consultant to both medical science businesses and government, and most importantly, a mother who took her science chops and her powerful intuition, and used it to cure her son of tragic brain-related injury using hemp-derived compounds that she herself made. Now, she works to merge science and the natural space through implementing cannabis and/or plant compounds in general into current modern medicine. More recently Dr. Annabelle has been pulled into some potential research for co-vid 19 treatment (you’ll hear more about that later in the episode).

Dr.Annabelle is also on the advisory board for our podcast sponsor Quanta! Quanta is an applied science company, focused on enhancing energy levels in plant matter (including cannabis) to increase performance within the human body.

This episode is sponsored by Quanta, an applied science company, focused on enhancing energy levels in plant matter (including cannabis) to increase performance within the human body. It is sold in hundreds of doctor’s offices, pharmacies and gyms and spas throughout the country. Their patented technology is proven to supercharge key ingredients and make them perform 5 times for effectively within the human body. It is optimized to drastically reduce both pain and inflammation naturally.

If anyone has not listen to Dr. Annabelle Morgan on the podcast below please do so. What she did to help her son is amazing!

What is more AMAZING is she is part of the Medofile Rx team.

AMAZING simply AMAZING

https://goingbeyondmovement.com/podcast/the-healing-side-of-science-with-scientist-dr-annabelle-morgan/