(Total Views: 447)
Posted On: 10/08/2020 10:13:28 AM
Post# of 155718
I agree that they need to get the MABs out. However it is not within the scope of the DSMC to issue an EUA.
They can only recommend to the sponsor and the FDA to continue or halt the trial. I would expect them only to halt the trial if they are confident that it would result in EUA.
Now, perhaps the FDA has advised them of the criteria they are looking for. Is it possible that they would consider an EUA for this scenario? One would hope, but it definitely falls outside of SOP.
They can only recommend to the sponsor and the FDA to continue or halt the trial. I would expect them only to halt the trial if they are confident that it would result in EUA.
Now, perhaps the FDA has advised them of the criteria they are looking for. Is it possible that they would consider an EUA for this scenario? One would hope, but it definitely falls outside of SOP.
(0)
(1)
