The science here is too strong, Leronlimab is safe

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The science here is too strong, Leronlimab is safe and very effective and needed by many resistant patients,

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Yes, I agree. I don't believe they had this situation before, at least with HIV, combo at 350mg at 81% at 24 weeks, but then last year mono around the same time coming in with 350mg at 40%, and 525mg over 70%, 700mg looking even higher, maybe even double 350mg. So for the FDA determined switching to the higher doses 525mg or 700mg is appropriate. Then that adds the wait for the safety data for 700mg.

With the big gap between 350mg and 525mg though in mono, especially since the have approved naive patients around 70% close to what 525mg was coming in at in mono, and combo MDR2+ drug approvals at 40%, it seems 525mg would have been the obvious choice to go with. But we will see what the FDA decides.

I believe this was the PR last November that after reading, the FDA decided combo should be at 700mg. As NP said, leronlimab is a victim of its own success. Without this, the BLA would be done now IMO, maybe even drug approval.

https://www.cytodyn.com/newsroom/press-releas...rapy-trial

Responder’s rate with 350 mg dose at approximately 44%
Responder’s rate with 525 mg dose at approximately 71%
Responder’s rate with 700 mg dose at approximately 92%