My take on the trials: 1) Enrollment of patient
Post# of 153815
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Posted On: 06/03/2020 1:51:57 PM
My take on the trials:
1) Enrollment of patient #50 in the severe trial occurred a few days ago, which allows for us to have data on 50 patients for the interim analysis at the end of June.
2) Cytodyn is working to enroll the 75th patient for Mild to Moderate by June 15th, but will unblind based on however many patients we have enrolled at that time, so that the data is available at the end of June also.
It is my belief that they are confident enough in what the data will show, to submit both data sets to the FDA at the same time, hence the hard date of 6/15.
I do not know how long it will take to process and package the data, nor how long it will take for the FDA to review the data. But I am confident both will be expedited.
I am expecting Cytodyn to provide us some insight into the data as soon as they process it. Could they begin processing some of the data before it is unblinded? I would expect so.
1) Enrollment of patient #50 in the severe trial occurred a few days ago, which allows for us to have data on 50 patients for the interim analysis at the end of June.
2) Cytodyn is working to enroll the 75th patient for Mild to Moderate by June 15th, but will unblind based on however many patients we have enrolled at that time, so that the data is available at the end of June also.
It is my belief that they are confident enough in what the data will show, to submit both data sets to the FDA at the same time, hence the hard date of 6/15.
I do not know how long it will take to process and package the data, nor how long it will take for the FDA to review the data. But I am confident both will be expedited.
I am expecting Cytodyn to provide us some insight into the data as soon as they process it. Could they begin processing some of the data before it is unblinded? I would expect so.
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