(Total Views: 568)
Posted On: 01/29/2021 3:57:53 PM
Post# of 154094
If the data is as strong as we hope it is, I think they should release it. With that said, if we are in fact sending the data to the FDA prior to our analysis, that should begin the process of an EUA.
My rush for the data (besides the fact that I cannot sleep) is so we can get to the important task of saving lives. The FDA requesting our data early will help with that.
It is also plausible that the FDA asks us to NOT send the top line data out until they are able to review and plan for the news to be released.
We havent really discussed this, but this may occur give the amount of public pressure to get this drug out. Think about it. If we reduce mortality, by say 50% the amount of pressure to get it out fast will be immense. They may want to get some of the work done ahead of time (if they arent already working on it)
My rush for the data (besides the fact that I cannot sleep) is so we can get to the important task of saving lives. The FDA requesting our data early will help with that.
It is also plausible that the FDA asks us to NOT send the top line data out until they are able to review and plan for the news to be released.
We havent really discussed this, but this may occur give the amount of public pressure to get this drug out. Think about it. If we reduce mortality, by say 50% the amount of pressure to get it out fast will be immense. They may want to get some of the work done ahead of time (if they arent already working on it)
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