Havasu, I appreciate your enthusiasm for leronl
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Posted On: 01/11/2021 2:58:46 PM
Havasu,
I appreciate your enthusiasm for leronlimab RO data, but I believe it is misplaced.
Clinical trials are double blinded for good reasons. Scientific rigor and the removal of doubt that investigators are influencing the outcome. Performing RO tests without FDA endorsement, would be monumentally stupid. It would essentially be cheating.
My appreciation of RO testing in the context of HIV is nearly full occupancy is required to reduce viral loads. It could be that the same is required for sufficient reduction of monocyte trafficking and lymphocyte exhaustion, but it could also be that this effect is proportionate to RO occupancy percentage.
Nonetheless, CD12 is intended to demonstrate safety of Leronlimab in critical Covid patients and efficacy demonstrated by reduced mortality and a number of secondary endpoints. RO data does not, to my knowledge support demonstration of hitting those endpoints.
RO data without clinical efficacy is meaningless in this trial.
If leronlimab is not effective, the degree of Leronlimab RO will not matter one iota. It will be no different than stellar safety data without efficacy.
Once CD12 results are available, Cytodyn would certainly be well advised to fine tune the dosing and delivery of leronlimab, an effort for which RO would be helpful.
First things first.
I appreciate your enthusiasm for leronlimab RO data, but I believe it is misplaced.
Clinical trials are double blinded for good reasons. Scientific rigor and the removal of doubt that investigators are influencing the outcome. Performing RO tests without FDA endorsement, would be monumentally stupid. It would essentially be cheating.
My appreciation of RO testing in the context of HIV is nearly full occupancy is required to reduce viral loads. It could be that the same is required for sufficient reduction of monocyte trafficking and lymphocyte exhaustion, but it could also be that this effect is proportionate to RO occupancy percentage.
Nonetheless, CD12 is intended to demonstrate safety of Leronlimab in critical Covid patients and efficacy demonstrated by reduced mortality and a number of secondary endpoints. RO data does not, to my knowledge support demonstration of hitting those endpoints.
RO data without clinical efficacy is meaningless in this trial.
If leronlimab is not effective, the degree of Leronlimab RO will not matter one iota. It will be no different than stellar safety data without efficacy.
Once CD12 results are available, Cytodyn would certainly be well advised to fine tune the dosing and delivery of leronlimab, an effort for which RO would be helpful.
First things first.
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