Even if the nw Guidelines for Monoclonal Antibodie
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Posted On: 02/22/2021 3:01:57 PM
Re: onestepahead #79275
Even if the nw Guidelines for Monoclonal Antibodies (Feb 2021) don't apply to Leronlimab, it is evidence that the FDA is "adapting" due to the dire pandemic crisis. Another piece of evidence for this, is the fact that the FDA asked for our s/c raw data as soon as it is unblinded.
Severe/Critical Covid-19 patients....what is the current SOC treatment?????
Remdesivir and steroids, that's it. The minor efficacy from Remdesivir was seen only in m/m patients, no benefit seen in s/c patients. The FDA, us, the world, needs leronlimab. Ivermectin for m/m and s/c is superior to remdesivir but is not being used. (see Dr Yo on youtube).
Nothing for s/c that is nearly as efficacious and safe as Leronlimab. The worst case scenario IMO, is that we barely missed the Primary Endpoint for s/c overall, and did obtain the Primary Endpoint for several sub-groups of s/c. Even in the worst case scenario, we really should be granted the EUA and soon.
Severe/Critical Covid-19 patients....what is the current SOC treatment?????
Remdesivir and steroids, that's it. The minor efficacy from Remdesivir was seen only in m/m patients, no benefit seen in s/c patients. The FDA, us, the world, needs leronlimab. Ivermectin for m/m and s/c is superior to remdesivir but is not being used. (see Dr Yo on youtube).
Nothing for s/c that is nearly as efficacious and safe as Leronlimab. The worst case scenario IMO, is that we barely missed the Primary Endpoint for s/c overall, and did obtain the Primary Endpoint for several sub-groups of s/c. Even in the worst case scenario, we really should be granted the EUA and soon.
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