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Re: jammyjames post# 139712

Friday, 10/20/2017 2:28:11 PM

Friday, October 20, 2017 2:28:11 PM

Post# of 690757
Jammy, safety or efficacy?

I would assume skipping a safety IA could be grounds for halting the trial.

For efficacy, the FDA allows sponsors to act as they wish on the results. So I see no reason why they would have a problem with the trial ongoing. But they might argue for an alpha penalty if it becomes a basis for a NDA/BLA submission.
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