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Posted On: 09/16/2020 12:42:05 PM
Post# of 148891
You think the outcome for placebo/SOC is going to be 3 times better than the best possible out come under Dexamethasone? Not a chance in hell.
Here is what I've previously outlined to someone else.
I think worst case scenario there's a 25% mortality rate in SOC and a 10% mortality rate for leronlimab. For interim that equals a p value of .007.
Even with a 25% / 14% mortality ratio we achieve statistical significance at p= .03977.
It's possible we don't hit p value at interim but from what we know from EIND outside of Montefiore very,very unlikely.
My 25% mortality factors in SOC rather than placebo. With the timeline of the trial most likely remdesivir with a lesser amount on IL-6 inhibitors and with a small amount of patients on corticosteroids.
The lesser amounts on corticosteroids and should not sway the study too much. IL-6 inhibitors should have no effect on our MOA. Remdesivir doesn't factor into a positive mortality rate. Where my annoyance comes in is that the FDA may claim that it may be another drug that decreased mortality. If it's an equal distribution of SOC drug types across both arms then it's obviously leronlimab. But there's no assurance that it's an equal distribution.
The 25% worst case scenario was based on the Dexamethasone's 25% mortality in non-invasive oxygen. The more intubated patients the greater an increase in the p value.
I excluded Montefiore results from the predicted results on the leronlimab arm. This exclusion criteria is indicative of organ failure so we would have no Montefiore type patients in the study.
Then of course there's the fact that the first 75 patients or so were against placebo not SOC.
Here is what I've previously outlined to someone else.
I think worst case scenario there's a 25% mortality rate in SOC and a 10% mortality rate for leronlimab. For interim that equals a p value of .007.
Even with a 25% / 14% mortality ratio we achieve statistical significance at p= .03977.
It's possible we don't hit p value at interim but from what we know from EIND outside of Montefiore very,very unlikely.
My 25% mortality factors in SOC rather than placebo. With the timeline of the trial most likely remdesivir with a lesser amount on IL-6 inhibitors and with a small amount of patients on corticosteroids.
The lesser amounts on corticosteroids and should not sway the study too much. IL-6 inhibitors should have no effect on our MOA. Remdesivir doesn't factor into a positive mortality rate. Where my annoyance comes in is that the FDA may claim that it may be another drug that decreased mortality. If it's an equal distribution of SOC drug types across both arms then it's obviously leronlimab. But there's no assurance that it's an equal distribution.
The 25% worst case scenario was based on the Dexamethasone's 25% mortality in non-invasive oxygen. The more intubated patients the greater an increase in the p value.
I excluded Montefiore results from the predicted results on the leronlimab arm. This exclusion criteria is indicative of organ failure so we would have no Montefiore type patients in the study.
Then of course there's the fact that the first 75 patients or so were against placebo not SOC.
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