Just want to add: some people still ask why the halt for screening new patients? Some people have provided various reason.
Simply put, if AA is in the process, or if the company via CRO knows the results have med prespecified requirement, continually screening, recruiting and enrolling patients according to the protocol is simple unethical.
So I believe the existing patients, ie those already enrolled in the trial are continually being treated according to protocol while no new patients are screened and recruited, and any patients in the pipeline are not randomized, until consultation with FDA, etc. is complete with directive results!
It could be AA granted or continue with the trial.
But, some other possibility still exists between the above and a safety issue.
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