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Posted On: 12/29/2020 1:48:38 PM
Post# of 154854
Oh, I understand what you meant now.
Open label trials (if done before double blinded trials), are not highly regarded as imperical evidence.
However, and this just my assumption, I believe that open label done as an extension of a completed trial, are viewed in a much different light, as its more logical to extend the results from the trial to the extension.
In other words without a trial, open label is not very strong. However, if we were able to add another 300 patients via open label, its much easier to assume that the results in the extension are not a fluke.
I have no idea how many patients we will add via open label. And, not sure it will have any impact on EUA, but it may be of value when we apply for full approval.
Open label trials (if done before double blinded trials), are not highly regarded as imperical evidence.
However, and this just my assumption, I believe that open label done as an extension of a completed trial, are viewed in a much different light, as its more logical to extend the results from the trial to the extension.
In other words without a trial, open label is not very strong. However, if we were able to add another 300 patients via open label, its much easier to assume that the results in the extension are not a fluke.
I have no idea how many patients we will add via open label. And, not sure it will have any impact on EUA, but it may be of value when we apply for full approval.
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