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Thursday, December 17, 2020 5:20:33 AM
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%
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