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Posted On: 09/09/2019 1:15:11 AM
Post# of 149480
Yes, good point, the drop is not instantaneous, it takes 6 weeks. I am also assuming there are some people needing the higher dose, say (oversimplification but just to simplify) they need 1600mg steady state based on Ccr5 density to keep all receptors covered. Then as the dose falls from 1800 to 1400, at some point they would have a VL spike.
Why do I assume that? There was still some failures at the 700mg dose after week 2, which would be higher than any point on 525mg. So I assume those failures—based on the mono phase 2 paper, and this trend we say last year of higher dosing better results—Ccr5 density distribution has some people in the very high end, and that is the reason. Obviously they have the data and would know what percentage that is. If it is low, then they are covered. They were going to assign it randomly after week 10 and the FDA requested the density test. So I’m assuming the FDA was thinking stratify based on density instead of random to fix this issue.
Why do I assume that? There was still some failures at the 700mg dose after week 2, which would be higher than any point on 525mg. So I assume those failures—based on the mono phase 2 paper, and this trend we say last year of higher dosing better results—Ccr5 density distribution has some people in the very high end, and that is the reason. Obviously they have the data and would know what percentage that is. If it is low, then they are covered. They were going to assign it randomly after week 10 and the FDA requested the density test. So I’m assuming the FDA was thinking stratify based on density instead of random to fix this issue.
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