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  4. CytoDyn Inc (CYDY) Message Board

Misiu143, I understand completely that there ar

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Post# of 154912
(Total Views: 626)
Posted On: 08/26/2020 9:19:01 AM
Posted By: CTMedic
Re: misiu143 #52294
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.



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