Peacekat, Maybe you are referring to LY-CoV555
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Posted On: 09/19/2020 1:09:30 PM
Peacekat,
Maybe you are referring to LY-CoV555 in combination LY-CoV016, antibodies that binds to a different area of COVID ???
I would be concerned with this as normally one has to understand why only one of the cohorts achieved virologic reduction. And worse, the middle dosage (not the higher, not the lower).
The advantage of higher patients-in-trial numbers is that the power is higher, that is, for a set threshold the possibility of rejecting the fact that the drug works is lower. With the small difference they achieved they will need a larger number of patients to achieve this objective.
This is why they are going now with 800 patients. I will be extremely surprised (and pissed off) if FDA grant them EUA with these poor results.
We have a much better "resolution" (differences), therefore we can pull it off with much less patients. With the assumptions I made something around 100 should suffice for moderate.
Maybe you are referring to LY-CoV555 in combination LY-CoV016, antibodies that binds to a different area of COVID ???
Quote:
The mid-stage study tested three different doses of LY-CoV555, an antibody treatment designed to recognize and lock onto the novel coronavirus, preventing the infection from spreading.
Of the total 302 patients treated with the Lilly drug, five or 1.7%, had to be hospitalized or required an emergency room visit. That compared with 6% in the placebo group, Lilly said.
"These data are not a home run but ... are among the most encouraging COVID treatment data we've seen, particularly given this is in mild-to-moderate outpatients where there has simply been no treatment progress until now," Raymond James analyst Steven Seedhouse said in a research note.
Oddly, only the middle 2,800-milligram dose achieved the trial's main goal of reducing the amount of virus detected in patients compared with a placebo 11 days after treatment. Lilly said most trial participants, including those given a placebo, had completely cleared the virus by day 11.
I would be concerned with this as normally one has to understand why only one of the cohorts achieved virologic reduction. And worse, the middle dosage (not the higher, not the lower).
The advantage of higher patients-in-trial numbers is that the power is higher, that is, for a set threshold the possibility of rejecting the fact that the drug works is lower. With the small difference they achieved they will need a larger number of patients to achieve this objective.
This is why they are going now with 800 patients. I will be extremely surprised (and pissed off) if FDA grant them EUA with these poor results.
We have a much better "resolution" (differences), therefore we can pull it off with much less patients. With the assumptions I made something around 100 should suffice for moderate.
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