This debate about what the FDA has or hasn't seen is neglecting the most significant (and absolutely certain) information we all know has been sitting on their desks for years: safety.
They know it's safe. Hundreds of HIV patients, over years can attest to that. "Safer than placebo" results in CD10 / Mild & Moderate Covid proved that. (That's code for "efficacy"
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Safety will not be an issue in the slightest, as evidenced by the resumption of eINDs and the green light for trial sites to continue to administer Leronlimab to severe & critical Covid patients, past full enrollment. The FDA won't do that just for shits and giggles.
Manufacturing can't be an issue... What we have is all there is and it's all needed. It's the only tool that can be brought to beat on severe / critical, other than dex and ventilators/HFNC. We all know how well those are working.
It's proven safe. If it has even a mild, 10% or so benefit to mortality, it's golden. If it reduces LH symptom severity or hastens time to improvement, it'll get EUA or approval.
Odds that neither will apply are rapidly dwindling.
They know it's safe. Hundreds of HIV patients, over years can attest to that. "Safer than placebo" results in CD10 / Mild & Moderate Covid proved that. (That's code for "efficacy"
. Safety will not be an issue in the slightest, as evidenced by the resumption of eINDs and the green light for trial sites to continue to administer Leronlimab to severe & critical Covid patients, past full enrollment. The FDA won't do that just for shits and giggles.
Manufacturing can't be an issue... What we have is all there is and it's all needed. It's the only tool that can be brought to beat on severe / critical, other than dex and ventilators/HFNC. We all know how well those are working.
It's proven safe. If it has even a mild, 10% or so benefit to mortality, it's golden. If it reduces LH symptom severity or hastens time to improvement, it'll get EUA or approval.
Odds that neither will apply are rapidly dwindling.
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