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Posted On: 08/21/2022 8:19:52 AM
Post# of 148878
Thanks ohm! In looking at this, it does seem the problem is the lack of organizing the data to show sub group comparisons and dose comparisons. Basically what was submitted just said we had this many safety issues attributed to leronlimab and compared it to placebo. What the fda is asking for is to show safety issues related to dose amounts, demographics of patients etc. I don’t understand why this takes months to accomplish once we had the data from Amarex. My guess is that posssibly the safety events are not documented to each patient and the patients other profile information? Seems not too hard to fix to me, but I’m not looking at the data.
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