From ClinicalTrials.gov "Institutional review boa
Post# of 153880
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Posted On: 05/28/2020 1:42:21 PM
From ClinicalTrials.gov
"Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards)."
I would expect CYDY's trials are monitored and could be halted if they determined that the patients getting placebos were being harmed. This would end the trials with immediate approval of Leronlimab. If Leron is as good as we believe this may be possible particularly in the severe trial.
Maybe I am just overoptimistic
"Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards)."
I would expect CYDY's trials are monitored and could be halted if they determined that the patients getting placebos were being harmed. This would end the trials with immediate approval of Leronlimab. If Leron is as good as we believe this may be possible particularly in the severe trial.
Maybe I am just overoptimistic
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