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LPF91

09/23/21 1:06 PM

#33578 RE: The Other Guy #33575

Imho I think that we received a standard phrase like this one from another fda rejection letter :

"FDA remains committed to fostering the development and availability of potential
treatments for COVID-19. Despite FDA declining to issue an EUA for
hydroxychloroquine sulfate at this time, FDA remains committed to working with you
and other interested parties in the development of products to prevent or treat COVID-
19. If and when additional data become available, such as data from randomized
controlled trials, that you believe is adequate to enable FDA to conclude that the known
and potential benefits outweigh the known and potential risks of this product, you can
submit a new EUA request to FDA at that time. We will review any such submission
promptly.
Forward all future EUA-related communications, in triplicate, identified by the above pre-
EUA number, to the following address:"