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Thursday, February 08, 2018 4:19:31 AM
Here is the bits where Missling responds to the purpose of the genetic profiling (with my marked edits fixing the transcription).
So the answer to that question is, the sequence is done independently by a third-party and the analysis of this is then included in the KEM analysis tool of Ariana. So the overall outcome is the prior analysis done of consideration response, which we presented last year at CTAD. And now, including this genetic information will be together analyzed. So that is the overall precision-medicine approach, which is being called precision-medicine.
So with the goal of the exercise is to increase the homogeneity of the study population and avoids the noise, which is caused by homogeneity of a study population. So the goal is to find patients, which are responding to the drug. And if they have the [consideration] concentration of the drug in the right amount and to avoid patients who are not responding to the drug despite having the right [consideration[ concentration and that is what we try to accomplish with that.
So this could be done. This could be the outcome of that could be either a positive marker or a negative marker. So if it's a positive marker, we would enrich with that biomarker. If it was a negative marker, patients with that mutation declining more than usual or declining without impact on the drug, then we would exclude those patients in the study. So you will find the answer in the scientific upcoming meeting.
No mention of the gut microbiome. Is that where we should look for the answer to drug blood concentration, or was it simply the relationship between pre-planned dosing groups throughout Part B or something else?
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