ombowstring, I would believe that to be the cas
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Posted On: 02/17/2021 5:00:39 PM
Re: ombowstring #78395
ombowstring,
I would believe that to be the case, but some here with direct trial experience, (I forget who, maybe Jlang, Kabonk), have repeatedly reminded us how laborious the data validation process can be. Apparently (beyond my experience) Amarex is a relatively small CRO with limited resources, so process could be even slower than one would expect or want.
The FDA will not get the data until Amarex has completed its work.
The topline data should be available very quickly.
If one assumes the data has been unblinded, then the delay argues for activity between the FDA and Cytodyn handling EUA/approval, distribution and increased manufacturing.
The simplest explanation is that data validation (again response from the Clinical sites required to address mistakes/missing data) has taken longer than we expect.
Either guess is valid and I have no way to judge the likelihood of which is correct.
Hitting the endpoint with relative reduction of mortality of more than 31% will be sufficient for EUA (thanks Techguru, Borel Fields, and DaveEl for our stats)
I would believe that to be the case, but some here with direct trial experience, (I forget who, maybe Jlang, Kabonk), have repeatedly reminded us how laborious the data validation process can be. Apparently (beyond my experience) Amarex is a relatively small CRO with limited resources, so process could be even slower than one would expect or want.
The FDA will not get the data until Amarex has completed its work.
The topline data should be available very quickly.
If one assumes the data has been unblinded, then the delay argues for activity between the FDA and Cytodyn handling EUA/approval, distribution and increased manufacturing.
The simplest explanation is that data validation (again response from the Clinical sites required to address mistakes/missing data) has taken longer than we expect.
Either guess is valid and I have no way to judge the likelihood of which is correct.
Hitting the endpoint with relative reduction of mortality of more than 31% will be sufficient for EUA (thanks Techguru, Borel Fields, and DaveEl for our stats)
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