(Total Views: 522)
Posted On: 03/08/2021 8:02:54 PM
Post# of 153898
Doctor580 wrote:
See my prior posts. The trial won't fill unless eind and ole is stopped and if it's stopped by us and not forced by fda we will be part of a class action law suit as well as the FDA. I would not allow my pt to into a double blind study of a drug already proven to decrease mortality if was available another way I could guarantee they get the drug
my response:
Dr Nader P stated that they will be terminating the eINDs and the OLEs both. The same occurred in May 2020 when (very successful) LL eINDs were stopped to initiate our clinical trials. FDA will support our ending eIND and OLE, as is common, the obvious, who would be motivated to enter a trial with a 66.3% chance of getting the new efficacious drug, when they can get in via eIND or OLE, With no alternative for LL or any other efficacious drug, critical folks should be very motivated to enter this 140 patient trial.
I wonder who they will exclude? Next step is to submit trial protocol to the FDA.
They may be able to fly to the Philipines or Brazil to get Leronlimab.
See my prior posts. The trial won't fill unless eind and ole is stopped and if it's stopped by us and not forced by fda we will be part of a class action law suit as well as the FDA. I would not allow my pt to into a double blind study of a drug already proven to decrease mortality if was available another way I could guarantee they get the drug
my response:
Dr Nader P stated that they will be terminating the eINDs and the OLEs both. The same occurred in May 2020 when (very successful) LL eINDs were stopped to initiate our clinical trials. FDA will support our ending eIND and OLE, as is common, the obvious, who would be motivated to enter a trial with a 66.3% chance of getting the new efficacious drug, when they can get in via eIND or OLE, With no alternative for LL or any other efficacious drug, critical folks should be very motivated to enter this 140 patient trial.
I wonder who they will exclude? Next step is to submit trial protocol to the FDA.
They may be able to fly to the Philipines or Brazil to get Leronlimab.
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