Quanta Inc (fka QNTA)

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An IND application may go into effect: 30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or. on earlier notification by FDA that the clinical investigations in the IND may begin.

After submitting IND application initially the FDA requested more information:


Medolife Rx Announces Positive Results in Clinical Safety Study on Its Polarized Drug Candidate for the Treatment of COVID-19

March 18, 2021

Medolife" a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. announced today positive results in a safety and toxicity study conducted on its polarized drug candidate derived from a small molecular peptide found in scorpions, designed to treat patients with the SARS-CoV-2 virus, also known as COVID-19. The results showed no signs of toxicity in any of the patients involved in the study who were given the drug Escozine®, which is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife.
The study, which was conducted in Santo Domingo of the Dominican Republic under the supervision of medical principal investigators, was conducted on over 500 patients, where data from one group of patients was used in the Company’s FDA pre-IND filing. Each patient was given Escozine® sublingually four times a day. During and after administration, a complete blood count (CBC) was conducted on each patient where the researchers measured various parameters to evaluate if the drug candidate was safe, such as hemoglobin (Hb), hematocrit (HCT), and red blood cells (RBCs) levels. There were no significant differences observed before or after administration. Additionally, there were no significant differences observed in white blood cells (WBCs), neutrophils, lymphocytes, monocytes, or eosinophils, concluding that the drug candidate was safe and non-toxic.
“A successful safety study is a pivotal step in the clinical development program for a new drug candidate and we could not be more enthusiastic about our results,” said Medolife CEO Dr. Arthur Mikaelian. “While our near-term goal is to work with the Ministry of Environment of The Dominican Republic to bring this drug to market, we are able to use this data in our programs around the world, including with our submissions to the United States Food and Drug Administration. While there is significant research that suggests the potential therapeutic benefits of extracted scorpion peptide, when paired with our proprietary polarization technology that increases efficacy and bioavailability in the body, we believe our product Escozine® could be a true breakthrough in the field of medicine with applications in a variety of focus areas and indications.”
The Company is currently involved in various clinical studies on Escozine® around the world. It is seeking product registration in the Dominican Republic for treatment of COVID-19 where this study took place, while simultaneously seeking approval in the United States, where it has filed data on Escozine® with the US Food and Drug Administration (FDA) as a Pre-Investigational New Drug (PIND #150335) as a COVID-19 therapeutic. Registration in the Dominican Republic would act as a proof-of-concept on the drug that would propel it forward in its path to market.

Medolife’s patented polarization technology increases the potency of single molecules and complex compounds. This technology is already used in various Medolife products, ranging from supplements to drug candidates.

So before the 30 days were up FDA notify the need for more information and on April 13, 2021 QNTA released a PR:

Medolife Rx Submits Final Data Set to FDA for IND Filing on Lead Drug Candidate


The Company assembled detailed information regarding the manufacturing of Escozine®, clarity on dosing, as well as both previous and new safety and efficacy data derived from an on-going human study taking place in the DR. The study has been conducted on over 500 participants and intends to demonstrate the safety and efficacy of Escozine®. Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the DR where the Company is seeking product registration. Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.
“The FDA-approved therapeutic drug market is the gold standard globally and should we receive IND designation from the FDA, it would catapult our other research across the world,” said Medolife CEO Dr. Arthur Mikaelian. “Submission to the FDA is never easy, but we are generating such positive clinical trial results that we are confident the regulatory body will take notice. They have been reviewing our submission for some time, requesting various other information that we have now submitted. I believe this could be the last request ahead of approval, which would be tremendous not only for our Company, but for patients who are in need of a solution where one does not currently exist. An approval from the FDA would also propel interest from the scientific community on the potential therapeutic benefits of the natural peptides we are studying, including investment and partnership interest.”
The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the US and globally. It is seeking product registration in the DR for treatment of COVID-19 through its exclusive relationship with the Ministry of Health. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds.
https://www.otcmarkets.com/stock/QNTA/news/story?e&id=1862474

One of two things WILL HAPPEN at the end of the 30 days, the approval goes forward or we get a Press Release if FDA requires more information.

Until then the stock will probably continue to be very unstable and unpredictable and getting more stable as we move closer to the 13TH.

For anyone who wants to get a better feel for Scorpion Venom check out the video below:

https://news.yahoo.com/why-scorpion-venom-most-expensive-160636769.html#:~:text=Its%20venom%20costs%20%2439%20million,expensive%20liquid%20in%20the%20world.