Ohm, Yeah, we have a total of 23% deaths in our
Post# of 155672
(Total Views: 736)
Posted On: 10/01/2020 8:43:42 AM
Ohm,
Yeah, we have a total of 23% deaths in our CD12 trial. I believe the thing here is to split Severe and Critical. We know critical (of course) has a larger number of deaths.
And this is when lady luck comes
(or doesn't).
We can "play" with numbers al day through. We now know for certain that the placebo has to have much more more than 23% and we (LL) have to have much less than that.
Or, putting it in another way: placebo has to have more than 15 and LL much less than 30 deaths.
If we know the total is 45, the question is: how many ???
There is not set-in-stone criteria. If we use the so-called strict alpha adjustment we are looking at 0.0054 at interim. However FDA might (or might not) stop the trial with this value.
I believe they will as they have granted emergency for much less than that. And we are talking number of deaths here. As in SAVING lives if we probe it, of course.
However we are talking FDA.
Now, back to the how many question. imo a delta of 9 (24 deaths placebo, 21 LL) will not give FDA any room to maneuver. They MUST stop the trial right then.
However, in light of the circumstances and with the fall spike in cases looming large FDA should approve LL with a smaller delta. I am not going to speculate any further as I don't trust them and will stick with the numbers as above.
In any case, the large number of deaths works in our advantage and we should feel content in that our drug is having its day in court. Let's hope the judge is fair and balanced.
Yeah, we have a total of 23% deaths in our CD12 trial. I believe the thing here is to split Severe and Critical. We know critical (of course) has a larger number of deaths.
And this is when lady luck comes
(or doesn't). We can "play" with numbers al day through. We now know for certain that the placebo has to have much more more than 23% and we (LL) have to have much less than that.
Or, putting it in another way: placebo has to have more than 15 and LL much less than 30 deaths.
If we know the total is 45, the question is: how many ???
There is not set-in-stone criteria. If we use the so-called strict alpha adjustment we are looking at 0.0054 at interim. However FDA might (or might not
) stop the trial with this value. I believe they will as they have granted emergency for much less than that. And we are talking number of deaths here. As in SAVING lives if we probe it, of course.
However we are talking FDA.
Now, back to the how many question. imo a delta of 9 (24 deaths placebo, 21 LL) will not give FDA any room to maneuver. They MUST stop the trial right then.
However, in light of the circumstances and with the fall spike in cases looming large FDA should approve LL with a smaller delta. I am not going to speculate any further as I don't trust them and will stick with the numbers as above.
In any case, the large number of deaths works in our advantage and we should feel content in that our drug is having its day in court. Let's hope the judge is fair and balanced.
(11)
(0)