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Posted On: 08/26/2020 9:19:01 AM
Post# of 153778
Misiu143,
I understand completely that there are pole trials. When leronlimab is approved in HIV, open label in a number of the cancers would be appropriate.
In the situation in which a drug has been not been approved for any indication, and in which there is not a consensus about a disease pathology, open label will not lead to approval or even concrete evidence of efficacy, IMO. Essentially that would produce more anecdotes.
Leronlimab and Cytodyn remain in a degree of limbo, even with a double blinded placebo controlled study and after very positive multiple EINDs.
I ask that someone explain to me how conducting an open label study would have provided more evidence of efficacy and produced a more rapid response by the FDA.
I understand completely that there are pole trials. When leronlimab is approved in HIV, open label in a number of the cancers would be appropriate.
In the situation in which a drug has been not been approved for any indication, and in which there is not a consensus about a disease pathology, open label will not lead to approval or even concrete evidence of efficacy, IMO. Essentially that would produce more anecdotes.
Leronlimab and Cytodyn remain in a degree of limbo, even with a double blinded placebo controlled study and after very positive multiple EINDs.
I ask that someone explain to me how conducting an open label study would have provided more evidence of efficacy and produced a more rapid response by the FDA.
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