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anders2211

02/24/19 5:40 AM

#215580 RE: marzan #215579

EX argues FDA doesn't have a say to end the trial that it is up to the sponsor if there is no safety issue.



Ex is right in general but not in the case of a hold.
see: https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.



Apparently, NWBO has met "Federal standards" again and was therefore allowed to proceed with the trial.