Should we not be going after CRP as an endpoint? A
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Quote:
Should we not be going after CRP as an endpoint? Am I misunderstanding or does Dr. JL think we did see a good response in the NASH study?
We would have to use CRP as one of the endpoints. It is the most established marker for inflammation and the main one that the FDA is going to want. A proper set of tests would establish why a myriad of other inflammatory markers are going down significantly but CRP is barely moving. At that point you can establish a rationale for why and convince the FDA that it's not an appropriate endpoint for leronlimab. It's something that must be done. To be stuck with an unachievable endpoint that is not relevant because the drug achieves the main goal another way is untenable.