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Posted On: 12/24/2022 3:59:35 PM
Post# of 148903
Re: chazzledazzle #131940
I don’t think you were dreaming, I remember the GI SAE slide too and don’t trust my memory on this but thought they did not attribute it to Leronlimab. My sense is the work Cytodyn is finishing for the FDA to get the hold lifted isn’t quick or trivial…I don’t know if the trial data capture for side effects is normalized or not (any free text?) but it needs to be categorized systematically, differentiated by attribution, severity etc. I did a project once where allergy reaction data had to be normalized into discrete categories for statistical analysis and it can be pretty tedious. Maybe we get an announcement next week it is completed and submitted; regardless they have hinted it is close or imminent…and I have a lot of confidence it will be a quality product that FDA will bless.
Unfortunate Amarex did not complete this task which belonged to them.
Unfortunate Amarex did not complete this task which belonged to them.
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