Trding, Good information. This is very telling
Post# of 154232
(Total Views: 1040)
Posted On: 04/23/2020 2:01:25 PM
Trding,
Good information. This is very telling to us as now we know what to expect in out 2b/3 Severe trial.
For arguments' sake lets asume that the "placebo" arm of our study yields the same results. The probability of success in the control arm is then 0.12
Using binomial distribution calculations we have that, if Leronlimab shows a survival of app. 46 patients (p=0.0364) we will be approved !!!
Now, lets asume that at the end of 50 patients in the Leronlimab cohort (that is 75 total) and if the FDA looks for a p number les than 0.05/10 to terminate the trial early for compelling evidence (this is an assumption only) we will need the survival of 14 patients (p=0.001763) as opposed to the theoretical 6. So, very roughly, if we demonstrate that our patients survive at a rate double that of the control group we would be approved early (given the assumption made above).
All this just to play around with the numbers so we all know approximately what to expect for our trial.
The key is p<0.05 and booom !!! wel will be approved !!!
Good information. This is very telling to us as now we know what to expect in out 2b/3 Severe trial.
For arguments' sake lets asume that the "placebo" arm of our study yields the same results. The probability of success in the control arm is then 0.12
Using binomial distribution calculations we have that, if Leronlimab shows a survival of app. 46 patients (p=0.0364) we will be approved !!!
Now, lets asume that at the end of 50 patients in the Leronlimab cohort (that is 75 total) and if the FDA looks for a p number les than 0.05/10 to terminate the trial early for compelling evidence (this is an assumption only) we will need the survival of 14 patients (p=0.001763) as opposed to the theoretical 6. So, very roughly, if we demonstrate that our patients survive at a rate double that of the control group we would be approved early (given the assumption made above).
All this just to play around with the numbers so we all know approximately what to expect for our trial.
The key is p<0.05 and booom !!! wel will be approved !!!
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