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Posted On: 07/18/2023 6:28:18 AM
Post# of 148903
Jake, in your research, what Biomarker do you think has been insufficient at least in means of capture, documentation, legitimacy, recording, etc that may have discounted LL's safety profile?
Which surrogate biomarker do you think might be considered that the new HIV trial protocol for safety may collect according to PharmacoVigilance GCP FDA Guidelines and Standards?
Do you think that a possible reason for why Safety or Risk/Benefit Analysis has not been accepted yet is due to the change in Primary End Point where originally is was Viral Load and then for cost purposes, some of the End Points were measured using Receptor Occupancy?
If that is the case, neither of those end points have anything to do with Safety. They only have to do with efficacy.
Which surrogate biomarker do you think might be considered that the new HIV trial protocol for safety may collect according to PharmacoVigilance GCP FDA Guidelines and Standards?
Do you think that a possible reason for why Safety or Risk/Benefit Analysis has not been accepted yet is due to the change in Primary End Point where originally is was Viral Load and then for cost purposes, some of the End Points were measured using Receptor Occupancy?
If that is the case, neither of those end points have anything to do with Safety. They only have to do with efficacy.
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