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Posted On: 05/26/2020 7:29:40 PM
Post# of 149732
If we want to look for positives in the CC, we will find it. There is plenty to be excited about in the coming months.
If we want to look for the negatives in the CC, we will find those things too.
Such is life.
There have been numerous comments about the necessity of enrollment. I agree this is key in hitting the numbers the FDA is wanting. Not hitting those enrollment numbers will give the FDA cause to send us back for more data and make for delays.
Perhaps someone in the medical field can answer this for me:
As we are engaged in patient enrollment, do we need to be concerned about the diversity of our enrollment? What about the diversity of the patients we have already treated?
What is our efficacy between races? How different are those numbers?
My point is this, to not give the FDA any reason to not move us forward as we try to gain approval for Leronlimab.
Is this a potential area of concern?
If we want to look for the negatives in the CC, we will find those things too.
Such is life.
There have been numerous comments about the necessity of enrollment. I agree this is key in hitting the numbers the FDA is wanting. Not hitting those enrollment numbers will give the FDA cause to send us back for more data and make for delays.
Perhaps someone in the medical field can answer this for me:
As we are engaged in patient enrollment, do we need to be concerned about the diversity of our enrollment? What about the diversity of the patients we have already treated?
What is our efficacy between races? How different are those numbers?
My point is this, to not give the FDA any reason to not move us forward as we try to gain approval for Leronlimab.
Is this a potential area of concern?
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