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Posted On: 04/07/2020 8:51:51 AM
Post# of 148908
Re: SouthernGold #26002
They announce the agreement in the works to run the trial in the UK and this follows, which to me says this is the design of the trial they are going to run:
“ The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway. The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.”
Then immediately after this paragraph they add this, which tells me the information above is different than the mild to moderate and severe trial “in the US”:
“CytoDyn has initiated enrollment in a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and is enrolling in a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population.”
“ The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway. The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.”
Then immediately after this paragraph they add this, which tells me the information above is different than the mild to moderate and severe trial “in the US”:
“CytoDyn has initiated enrollment in a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and is enrolling in a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population.”
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