That isn't the way it works. The trial would start
Post# of 148164
(Total Views: 545)
Posted On: 10/19/2020 3:45:47 AM
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That isn't the way it works. The trial would start up again exactly where it left off. The data from the 195 patients in the interim cohort would be added to the remaining 195.
Okay, I stand corrected. But, it still seems unduly disruptive if that were to happen.
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The determination of a halt is solely up to the company. The FDA recommends that you discuss it with them before a halt.
We are saying the same thing here.
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If the company set a schedule based on any non-statutory FDA timeline they're fools.
Not sure what you are getting at here. Are you suggesting that the company should not have set a CC for this week?
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