(Total Views: 567)
Posted On: 02/06/2021 12:11:52 AM
Post# of 155843
arbo99 wrote:
I am tired of writing this but here it goes again. One should not get nervous because it is taking so long for a FDA response. On the other hand. One should be very excited that by taking so long each day our chances are looking better and better,
my response:
Agreed. Yes! Nader must report bad news within, what is it within 4 days? And Nader's team can calculate p value in about 10 seconds once they see unblinded data. If the data is poor, then no need to apply for an EUA from the FDA.
However, there is one scenario that is shaky.....if the Primary Endpoint is missed, barely missed, and Secondary Endpoints might "possibly" justify an EUA. What are the odds of this occuring? 10 to 1? 20 to 1?
I am tired of writing this but here it goes again. One should not get nervous because it is taking so long for a FDA response. On the other hand. One should be very excited that by taking so long each day our chances are looking better and better,
my response:
Agreed. Yes! Nader must report bad news within, what is it within 4 days? And Nader's team can calculate p value in about 10 seconds once they see unblinded data. If the data is poor, then no need to apply for an EUA from the FDA.
However, there is one scenario that is shaky.....if the Primary Endpoint is missed, barely missed, and Secondary Endpoints might "possibly" justify an EUA. What are the odds of this occuring? 10 to 1? 20 to 1?
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