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Re: LPF91 post# 33329

Monday, 09/13/2021 1:09:10 AM

Monday, September 13, 2021 1:09:10 AM

Post# of 42552

So if now we are enrolling 500pt, we can assumed that at minimum the new 300 pt will have CRP < 150.



For the current protocol CRP < 150 is not listed in the inclusion criteria. CRP > 150 is not listed in the exclusion criteria. If they decide to exclude outside of the scope of the criteria the FDA will not even consider reviewing the trial data. But I think the NIH is a little smarter than to do that.