Maybe the main issue here is that the FDA is conce
Post# of 148162
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Posted On: 03/22/2021 1:14:04 PM
Maybe the main issue here is that the FDA is concerned about giving placebo to critical patients who will then die, when many of them could have "LIVED" if given leronlimab.
So take it from there as to what is going to happen with CD16 and the timing of our EUA????? Who knows,..... maybe FDA is in a tough spot that will result in our EUA being given quickly?
Add the folks from the s/c trial then stop CD16 enrollment on March 27th, then initiate OLE and eIND nationwide or EUA. Evaluate CD16 data for Full Approval, save lives and send SP to new highs (please).
So take it from there as to what is going to happen with CD16 and the timing of our EUA????? Who knows,..... maybe FDA is in a tough spot that will result in our EUA being given quickly?
Add the folks from the s/c trial then stop CD16 enrollment on March 27th, then initiate OLE and eIND nationwide or EUA. Evaluate CD16 data for Full Approval, save lives and send SP to new highs (please).
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