Can anyone fill me in here?
Has the Gilead product been approved by the FDA for Covid-19? Based on which trial?
If they didn't do a P3 RCT - how was the product approved by the FDA?
Mesoblast had to toe the line and gone through a long, arduous & costly FDA process - I wouldn't like to see other companies skip this process. It is there to ensure a safe & quality outcome!
Cell Therapy News/Articles, page-4217
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