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  4. CytoDyn Inc (CYDY) Message Board

The new data for Open Label Extension, will of cou

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Post# of 154011
(Total Views: 615)
Posted On: 01/08/2021 5:58:37 PM
Posted By: calstang
Re: ohm20 #71950
The new data for Open Label Extension, will of course only be for s/c patients receiving leronlimab. And the death rate should only be lower for these leronlimab folks, maybe 10 to 14 %, because SOC has improved. This should only help our % reduction of death. To say there is no placebo group now, is misleading. The placebo group is the 130 set when the Open Label Extension started and "Full Enrollment" was reached. (Maybe 132 placebo since we went above 390 to 394)

During the 2nd half of the s/c trial, SOC has lowered the death rate of both placebo group and LL group. Now, there will be power added, as total participants is increasing with OLEx and if death rate is lower for these LL folks, it only helps our p value. It appears Long CYDY folks are not concerned about p value.

Does the ratio of placebo to LL folks effect the power? Because the ratio is increasing, to maybe 2.25 to 1 by the time unblinding occurs.


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