Good to go, FDA will need data from all patient
Post# of 148179
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Posted On: 05/13/2020 9:22:11 PM
Re: Good to go #33895
Good to go,
FDA will need data from all patients to calculate the "goodness" of the drug (so to speak). Due to the fact that there are only 75 patients a smaller number will not have a good power factor.
Yes, they would stop the trial if there are safety issues. Those are normally reported to FDA immediately form centers for that purpose. However Leronlimab is pretty safe and there will not be SAE's.
FDA will need data from all patients to calculate the "goodness" of the drug (so to speak). Due to the fact that there are only 75 patients a smaller number will not have a good power factor.
Yes, they would stop the trial if there are safety issues. Those are normally reported to FDA immediately form centers for that purpose. However Leronlimab is pretty safe and there will not be SAE's.
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