Enzolytics Inc (ENZC)

[Shell Man]

The COVID relationship quote:

"Additionally, ImmunoTech BG-Europe has informed Enzolytics that they will be seeking to register the ImmunH product as a ImmuneModulator, allowing use as an adjunct in additional applications to regulate or normalize the Immune System."

This is in the European Union and as you can see here there is a bonding agreement where the FDA and the EU have a mutual recognition agreement paving the way for this to be used also in the USA.

Bulgaria where phase III is complete was admitted into the agreement April, 2019.


https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra#:~:text=The%20Mutual%20Recognition%20Agreement%20(MRA,conducted%20within%20each%20other's%20borders.&text=Yields%20greater%20efficiencies%20for%20U.S.,by%20avoiding%20duplication%20of%20inspections

"The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements. FDA and the EU have collaborated since May 2014 to evaluate the way they each inspect drug manufacturers and assess the risk and benefits of mutual recognition of drug inspections."