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Posted On: 04/07/2020 10:32:06 PM
Post# of 148985
Re: thriftycents #26210
“ .. not to mention 800+ in HIV ... but why doesn't the FDA simply approve our drug for the general purpose of restoring the immune system.”
Keep in mind that the MOA for HIV is not the same as for any of our other indications. Leronlimab does not restore the immune system in HIV patients; rather, it blocks the receptor that HIV uses for cell entry.
Those 800+ patients provide clear evidence that our product is safe (which is why we keep jumping straight to Phase 2), but they do not provide evidence of efficacy in restoring immune function.
Of course, I have no doubt that the evidence will be forthcoming in the next couple weeks.
Keep in mind that the MOA for HIV is not the same as for any of our other indications. Leronlimab does not restore the immune system in HIV patients; rather, it blocks the receptor that HIV uses for cell entry.
Those 800+ patients provide clear evidence that our product is safe (which is why we keep jumping straight to Phase 2), but they do not provide evidence of efficacy in restoring immune function.
Of course, I have no doubt that the evidence will be forthcoming in the next couple weeks.
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