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Posted On: 04/23/2021 4:38:48 PM
Post# of 148923
Quote:
Just because a trial is ran in another country, especially one that is intended to present supplemental data to cd12, does it necessarily mean that the new data cannot be used to support a US FDA EUA?
Correct, but in the meantime I'd really focus my energy on the regulatory agencies in those countries and afterwards casually and disinterestedly tell the FDA "Oh sure, I guess you can look at these amazing results too if you want." Then dangle them really high so the FDA has to jump to reach them.
Maybe the FDA is like that hot girl in college who only wants what she can't have. Let's test that theory.
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