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Posted On: 12/25/2020 12:53:07 AM
Post# of 148908
"The results of our CD10 trial will not support an eIND request.”
A strange and surprising statement. Like....where did that come from, or why would he say this????
There is another way to possibly look at this. Perhaps it was just a clumsy, nervous statement, but in a way, correct. The eIND usage the FDA recently granted to Cytodyn, was for s/c only, thus m/m patients would not have been allowed to get leronlimab. But why was the term "open label" included, will that allow doctors to treat m/m and longhaulers with leronlimab shots?
For s/c, it looks like the FDA will give a check list to doctors, so that the doctor can use the check list to qualify a patient for getting leronlimab, no eIND application to the FDA and wait, the doctor can place checks in the boxes and then inject the patient all within about 8 minutes. We should hike up our efforts to add s/c trial sites to increase the number of folks who can get LL shots.
A strange and surprising statement. Like....where did that come from, or why would he say this????
There is another way to possibly look at this. Perhaps it was just a clumsy, nervous statement, but in a way, correct. The eIND usage the FDA recently granted to Cytodyn, was for s/c only, thus m/m patients would not have been allowed to get leronlimab. But why was the term "open label" included, will that allow doctors to treat m/m and longhaulers with leronlimab shots?
For s/c, it looks like the FDA will give a check list to doctors, so that the doctor can use the check list to qualify a patient for getting leronlimab, no eIND application to the FDA and wait, the doctor can place checks in the boxes and then inject the patient all within about 8 minutes. We should hike up our efforts to add s/c trial sites to increase the number of folks who can get LL shots.
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