Cytodyn Inc (CYDY)

[weasel6667]

After a quick search I cannot find this requirement (EUA in country of origin) on the webpage of the FDA Philippines.
https://www.fda.gov.ph/category/circular/
I assume they would mention such an important and fundamental requirement on their own webpage!

This is what the FDA announced as condition for EUA:

VI. SPECIFIC GUIDELINES

A. Conditions for Issuance of the EUA

The EUA shall only be issued and remain valid only when all of the following circumstances are present:

1. Based on the totality of evidence available, including data from adequate and well- known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19;
2. The known and potential benefits of the drug or vaccine, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of the drug or vaccine, if any; and
3. There is no adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID-19.
The last condition is deemed present when there exists no registered drug or vaccine in the country for diagnosing, preventing or treating COVID-19.

There is no better description about our beloved Leronlimab!
Especially number 3 fits our CD12 trial to 100%