Was the real-world retrospective cohort receiving the same SOC protocols as the Remedesivir treated patients? That is same drug treatment regime outside of Remdesivir and other physical treatment procedures?
In the Gilead Sciences press release the table only included data to 14 days while the FDA would prefer to 28 days;
From
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
Guidance for Industry
https://www.fda.gov/media/137926/download
On page 6 regarding trial design, the guidance seems to be have been ignored. @tonystarkUSA can you point out where it adheres to the guidance?
On page 9 regarding time frames
Was the 14 day time frame agreed to by the FDA?
Is there allowance for collecting data on sustained recovery?
Cell Therapy News/Articles, page-4168
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