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CytoDyn Inc CYDY
(Total Views: 687)
Posted On: 05/17/2022 8:06:58 AM
Post# of 155608
Posted By: Nt2innvovate
Dr. Jay is being more emotional than logical here. I ain't no NP cheerleader but no way FDA was going to let Cytodyn do IV over SC when they do not trust small bio already and were already worried about leronlimab causing immunosuppression. IV would have probably required animal studies and human dose escalation which would have taken a year. Even Brazil took time to get up and running because of IV and the FDA is probably only tolerating it because American lives are not at risk. Not only that, they would probably have to redo CMC with Samsung and who knows how long that would take unless the feds step in and help out.

With regards to not being able to get 4 SC doses, that is kind off on Dr. Jay. as well as FDA. Dr. Yang didn't help either by doing all EIND instead of study. With his reputation and belief in leronlimab, he could have pushed enrollment before DSMC after which the age stratification issue occured. These guys are implicated here as much as NP.














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