The toxicity test is a non-issue as we already know the expected results from the 2020 Annual Report and other documented data:
ITV, produced by Enzolytics, Inc. is a brand-new specific protein for the treatment of HIV and other viral infections. For the first time a naturally occurring strong binding with gp41 HIV-1 envelope protein “in vitro” was demonstrated.
Current market sales indicate that the majority of products show annual sales of 100 plus million, with a significant number ranging from 300 million up to 1 billion dollars in annual sales. Many of the major drug companies, have entered into partnership agreements with newcomers, or with companies in different stages of development in the research pipeline, combining current ARVs with new drug families that impact the HIV/AIDS virus through different mechanisms of action. Partnerships of this nature are a direct result of the major seven Pharmas who control a market with a potential of reaching over $ 15 billion in year 2018, prevent their control and stake in the market share from sliding, due to numerous issues, among which it is important to note, compliance to the drug regimen, adverse reactions to their chemotherapeutic agents impacting the human organs, cost, and eventual viral resistance.
In summation our product’s differentiation is based on:
1- Minimal and minor side effects
2- Zero toxicity issues
3- Tremendous cost savings
4- Short and limited treatment cycle
5- Easier Compliance adherence
6- Zero risk of viral resistance and mutation
The only reason the toxicity study is being done is the FDA requires it. Once it is completed ENZC can submit an Investigational New Drug (IND) application.
The IND application must contain information in three broad areas: Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
I expect no press release on the toxicity study however I expect a release when the IND application is submitted.
