My understanding is that the pivotal trial will ha
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Posted On: 08/14/2019 7:31:44 AM
Re: Stramboat19 #6094
My understanding is that the pivotal trial will have two key changes that will improve results. The receptor occupancy test will determine the best dose vs the current random dosing. This should lift overall success rates and may even identify some that need higher doses than 700mg and they will not allow them in the trial.
Secondly (not addressed in this PR) the longer overlap period to ensure 5X half-life should prevent some of the early failures (I believe this will be 4 weeks vs current 1 week).
I’m curious if and how they will address any viral spikes such as trial patients getting the flu or something. That is the remaining factor I see that can have an impact on overall pivotal trial rates.
Secondly (not addressed in this PR) the longer overlap period to ensure 5X half-life should prevent some of the early failures (I believe this will be 4 weeks vs current 1 week).
I’m curious if and how they will address any viral spikes such as trial patients getting the flu or something. That is the remaining factor I see that can have an impact on overall pivotal trial rates.
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