2MartiniGI wrote: Please help. I read the above t
Post# of 153937
(Total Views: 336)
Posted On: 03/07/2021 6:59:20 PM
Re: 2MartiniGi #81728
2MartiniGI wrote:
Please help. I read the above that we are stat sig on 28 day mortality? If so, what is holding up EUA? What other Covid approved therapeutic beats that? Please explain in third grade language and don't type too fast I don't want to hurt my brain.
my response:
others will come in and explain with more detail. The Stat Sig 28 day mortality is not related to any of the Endpoints of this trial, Secondary or Primary. It is related to a "sub group" that was identified after the data came out, and it is not anything that the FDA will allow for consideration. Such findings can be used for future trials, example being to set "days stay in hospital" for our Primary Endpoint in the upcoming study of 140 critical patients (which we are doing and will hit.)
Please help. I read the above that we are stat sig on 28 day mortality? If so, what is holding up EUA? What other Covid approved therapeutic beats that? Please explain in third grade language and don't type too fast I don't want to hurt my brain.
my response:
others will come in and explain with more detail. The Stat Sig 28 day mortality is not related to any of the Endpoints of this trial, Secondary or Primary. It is related to a "sub group" that was identified after the data came out, and it is not anything that the FDA will allow for consideration. Such findings can be used for future trials, example being to set "days stay in hospital" for our Primary Endpoint in the upcoming study of 140 critical patients (which we are doing and will hit.)
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