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Posted On: 04/10/2019 3:27:27 PM
Post# of 72444
No one knows what the Phase 3 clinical trial design will be for sure. It's going to depend on what the FDA and EMA want.
Please stop claiming knowledge that no one has. Things can change rapidly when people are designing clinical trials, especially when they are trying to design a clinical trial that all regulatory agencies agree on. We have no idea how many people will be in the clinical trial, what the different arms of the trial will be, or even if they will require a control group, given the statistics that can be gathered from historical incidence of severe OM in the Head and Neck Cancer population.
I note that certain people present things as fact when they are not facts. They may be correct eventually, but they are not proven facts right now.
Please stop claiming knowledge that no one has. Things can change rapidly when people are designing clinical trials, especially when they are trying to design a clinical trial that all regulatory agencies agree on. We have no idea how many people will be in the clinical trial, what the different arms of the trial will be, or even if they will require a control group, given the statistics that can be gathered from historical incidence of severe OM in the Head and Neck Cancer population.
I note that certain people present things as fact when they are not facts. They may be correct eventually, but they are not proven facts right now.
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