Knowing this now that Merck has to get more data,
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Posted On: 02/26/2021 8:27:46 AM
Knowing this now that Merck has to get more data, it was a smaller trial than LL. I'm not sure if that is not why Cytodyn said they were going to send the data immediately to the FDA and why it took so long for the unblinding.
They must have been in contact with the FDA some time in Dec. or early Jan. as to the reporting of data. Seems plausible to me they may have been told by the FDA to collect the 42 day and as much of the 60 data as they could. So it could be analyzed and determine what kind of EUA would be granted. If there would be restriction like the opposite of Rem, only for severe, critical or if further dosing is required in the long term patients.
They must have been in contact with the FDA some time in Dec. or early Jan. as to the reporting of data. Seems plausible to me they may have been told by the FDA to collect the 42 day and as much of the 60 data as they could. So it could be analyzed and determine what kind of EUA would be granted. If there would be restriction like the opposite of Rem, only for severe, critical or if further dosing is required in the long term patients.
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