I do have to chime in on the HIV trials to give a
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Posted On: 04/13/2021 4:17:19 PM
Re: LaundryMoney #86533
I do have to chime in on the HIV trials to give a little history. I think most here that have been here invested over the past 1-3 years don't know the process the HIV trial protocol went through.
Basically, Cytodyn went with a trial as a mono drug, the FDA said no and wanted to compare Leronlimab in combo because all current drugs are combo. The Mono direction was just to forward thinking for the FDA. The win was that we could do an Investigational p3 trial as a mono and used data from that as part of the Safety portion of the combo trial. I think we all know how that now has twisted into merging both trial into one and the FDA obsessing over differences in each trial. The hope is that the combo approval will make the mono extension a short/easy path.
The difficulties with the Covid trials mirrors the HIV trials in that the FDA has led us down a nice path that leads to more trials instead of any approval. Cytodyn has learned a huge amount from this and I hate to see the FDA still being so difficult. The frustration we feel as investors is the same, probably more intense for mgmt.
Basically, Cytodyn went with a trial as a mono drug, the FDA said no and wanted to compare Leronlimab in combo because all current drugs are combo. The Mono direction was just to forward thinking for the FDA. The win was that we could do an Investigational p3 trial as a mono and used data from that as part of the Safety portion of the combo trial. I think we all know how that now has twisted into merging both trial into one and the FDA obsessing over differences in each trial. The hope is that the combo approval will make the mono extension a short/easy path.
The difficulties with the Covid trials mirrors the HIV trials in that the FDA has led us down a nice path that leads to more trials instead of any approval. Cytodyn has learned a huge amount from this and I hate to see the FDA still being so difficult. The frustration we feel as investors is the same, probably more intense for mgmt.
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