Sunday, May 09, 2021 10:37:02 AM
Proposal:
Add to the treatment cohorts of successfully completed trial any newly identified risk factors such as IDH to this population so that it may serve as a control cohort for future trials.
Obtain and test tissue from any ongoing trials for new risk factor analysis for future pooling considerations.
Will this help to satisfy outstanding concerns?
Create 5 year database to monitor real world safety and outcome. Consider collecting certain additonal endpoints to safety in order to explore pooling or validation of other trial sets.
Does this address that concern?
Can we shake on this? Will you put this in writing?
What can be done to satisfy other reporting requirements in this case?
Are there exceptions to any of your guidance?
How will we treat these conflicts moving forward?
Can we move on to the next questions about package requirements?
Do He even know what He is talking about or is he even remotely close?
See attached chain and apply statements within about advice.
Add to the treatment cohorts of successfully completed trial any newly identified risk factors such as IDH to this population so that it may serve as a control cohort for future trials.
Obtain and test tissue from any ongoing trials for new risk factor analysis for future pooling considerations.
Will this help to satisfy outstanding concerns?
Create 5 year database to monitor real world safety and outcome. Consider collecting certain additonal endpoints to safety in order to explore pooling or validation of other trial sets.
Does this address that concern?
Can we shake on this? Will you put this in writing?
What can be done to satisfy other reporting requirements in this case?
Are there exceptions to any of your guidance?
How will we treat these conflicts moving forward?
Can we move on to the next questions about package requirements?
Do He even know what He is talking about or is he even remotely close?
See attached chain and apply statements within about advice.
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