“Not comparable as equals, but very close to it.
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Posted On: 06/15/2020 11:10:12 PM
Re: nmbr1stckpckr #37872
“Not comparable as equals, but very close to it. Also, by relaxing the constraints, patients' path to eIND may have been headed off and re-directed into ph3 trials.”
The problem with the idea that potential EIND patients are being rerouted to the phase 3 severe trial is location. The trial is only established at a certain number of hospitals in certain regions. Many of the EINDs were most likely outside of those hospitals and that’s why they were given EINDs. It would make no sense for a patient in a hospital participating in the phase 3 trial to be given an EIND unless that patient met exclusion criteria.
Basically, I don’t buy the argument that potential EIND patients are now being routed to the severe trial. That just doesn’t seem likely with the trial limited to only certain hospitals. I believe the FDA may have helped by agreeing to relax exclusion criteria, but I believe that’s the extend.
The problem with the idea that potential EIND patients are being rerouted to the phase 3 severe trial is location. The trial is only established at a certain number of hospitals in certain regions. Many of the EINDs were most likely outside of those hospitals and that’s why they were given EINDs. It would make no sense for a patient in a hospital participating in the phase 3 trial to be given an EIND unless that patient met exclusion criteria.
Basically, I don’t buy the argument that potential EIND patients are now being routed to the severe trial. That just doesn’t seem likely with the trial limited to only certain hospitals. I believe the FDA may have helped by agreeing to relax exclusion criteria, but I believe that’s the extend.
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