Enzolytics Inc (ENZC)

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DA is considering all possibilities by any means that can shut Covid-19 down or keep it in check. ENZC technology can certainly help in this process. It is only a matter of time when we find out just how involved we are either leading the charge or part of a collaboration with another company.


https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-important-work-support-medical-product-development-address


Our agency has had experience with evolving infectious diseases. Influenza vaccines and diagnostics are often modified each year to address the predicted predominant strains circulating globally. The agency has created and used regulatory processes that facilitate these updates. We will utilize our experience with influenza to help inform a path forward if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective. Similarly, the FDA also has vast experience with HIV developing resistance to antiviral drugs and will follow regulatory pathways to quickly enable new antiviral drug development for resistant virus.

We have already been communicating with individual medical product sponsors to provide information as they evaluate the impact of COVID-19 variants on their products. And as part of our commitment to a public and transparent process, the FDA is developing guidances for diagnostic, therapeutic and vaccine developers to help guide ongoing medical product development.

For therapeutics, particularly virus-targeting monoclonal antibodies, we are considering approaches to help expedite drug development in this key area, including discussing appropriate regulatory flexibilities. We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations. Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing and controls data.

For authorized vaccines, our teams are currently deliberating and discussing the types of data needed to support changes in the composition of the vaccine, either through altering the existing vaccine or through the addition of new vaccine component(s), including how sponsors could demonstrate immune response to new variants through streamlined clinical programs that still gather the crucial data the FDA needs to demonstrate effectiveness, but can be executed quickly to gather this data. To be clear, while we continue to develop an understanding of and address any impact of variants on FDA-regulated products, at this time, available information suggests that the authorized vaccines remain effective in protecting the American public against currently circulating strains of COVID-19.