Weasel, From the 10Q: “In December 2021, B
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Posted On: 01/25/2022 8:28:44 AM
Weasel,
From the 10Q:
“In December 2021, Brazil’s ANVISA agreed to modify the Phase 3 trial for critically ill COVID-19 patients to require a total patient enrollment of 126 patients instead of the previously approved 316 patients and allow for interim efficacy analysis after 51 patients have been treated for 27 days.”
and
“As of January 6, 2022, the Brazilian Phase 3 trials for severe and critically ill COVID-19 patients had enrolled 38 and 6 patients, respectively.”
Brazil ANVISA I expect will evaluate the trials in Brazil. Meta analysis allows evaluation by US FDA if previous CD12 results in conjunction with Brazilian CD16&17 results.
I believe that good results of these trials, even without meta analysis of combination with CD12 results will be sufficient for Brazilian EUA.
Fingers crossed.
From the 10Q:
“In December 2021, Brazil’s ANVISA agreed to modify the Phase 3 trial for critically ill COVID-19 patients to require a total patient enrollment of 126 patients instead of the previously approved 316 patients and allow for interim efficacy analysis after 51 patients have been treated for 27 days.”
and
“As of January 6, 2022, the Brazilian Phase 3 trials for severe and critically ill COVID-19 patients had enrolled 38 and 6 patients, respectively.”
Brazil ANVISA I expect will evaluate the trials in Brazil. Meta analysis allows evaluation by US FDA if previous CD12 results in conjunction with Brazilian CD16&17 results.
I believe that good results of these trials, even without meta analysis of combination with CD12 results will be sufficient for Brazilian EUA.
Fingers crossed.
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