Again, read the FDA guidelines and NP comments, i.
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Posted On: 09/18/2020 12:11:29 PM
Again, read the FDA guidelines and NP comments, i.e. the sources I have provided. Their PR on that is ambigous, as usual, but fortunately NP clarified in that PI... Or ask the company directly, if you don't believe it.
DMC/DSMB ( Data and safety monitoring board) reviewing the data is the standard process for interim analyses btw, I have witnessed this with many companies (CRMD, CLSN, GILD). So it would surprise me if CYDY against FDA guidelines performs the analysis themselves.
Same with Gilead's COVID-19 trial:
https://www.nih.gov/news-events/news-releases...d-covid-19
DMC/DSMB ( Data and safety monitoring board) reviewing the data is the standard process for interim analyses btw, I have witnessed this with many companies (CRMD, CLSN, GILD). So it would surprise me if CYDY against FDA guidelines performs the analysis themselves.
Same with Gilead's COVID-19 trial:
https://www.nih.gov/news-events/news-releases...d-covid-19
Quote:
An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team. Based upon their review of the data, they noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials.
Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001 ).
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