Based on the videos, the first checkpoint will be
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Posted On: 04/08/2020 11:28:05 AM
Re: reallypeople? #26269
Based on the videos, the first checkpoint will be after 50 patients make it through the trial and there is an interim data checkpoint.
If the data is good, it will be shared with FDA at that point.
This is a 2 to 1 placebo controlled double blind study (neither the doctor nor the biotech company know if the patient is on drug or placebo) so no one with know results until the 50 patients checkpoint when a small DSMC ( data safety Monitoring Committee) reviews the data which must be cleaned and analyzed in the clinical data management system which takes to me.
I don’t know if it will be 50 patients at the primary or secondary endpoint which is a two week difference.
This will not be until May in my opinion.
All IMO but the have a project manager on clinical trials before and they are very structured and controlled as I have previously described
If the data is good, it will be shared with FDA at that point.
This is a 2 to 1 placebo controlled double blind study (neither the doctor nor the biotech company know if the patient is on drug or placebo) so no one with know results until the 50 patients checkpoint when a small DSMC ( data safety Monitoring Committee) reviews the data which must be cleaned and analyzed in the clinical data management system which takes to me.
I don’t know if it will be 50 patients at the primary or secondary endpoint which is a two week difference.
This will not be until May in my opinion.
All IMO but the have a project manager on clinical trials before and they are very structured and controlled as I have previously described
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