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xoc

Re: MinnieM post# 361436

Sunday, 06/06/2021 9:01:02 AM

Sunday, June 06, 2021 9:01:02 AM

Post# of 402685
 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention

This article above which I quote below contains recommendations about conduct and design of clinical trials on COVID from the FDA and explains why interim data analysis for efficacy will likely not be performed as “releasing interim results could have ramifications on the integrity of the ongoing trial and the ability to collect reliable and interpretable data needed to support regulatory decision-making.”

One can also see that our trial design appears to be following these recommendations for trial design and analysis to a T, hopefully facilitating EUA upon release of great results.






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