Thanks, X, I admit not carefully reading all 72 pages of the bammy EUA, but I did scan 20 or so. My comments aren't on the drug's efficacy, but on the report structure.
First, readers might want to refresh themselves on the actual breadth of phrasing of the "likely benefit which outweighs risk" language:
"Based on the totality of the scientific evidence available to FDA, ...
...it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, ...
...and when used under such conditions, the known and potential benefits of bamlanivimab outweigh the known and potential risks of the drug"
Second, note the listing and detailing of every trial. Third, peruse some of the charts around page 20. No way this granularity is embedded in the original endpoint definition.
So, yes, thank you, this is a great example suggesting that in an EUA filing, as distinct from an approval filing, the FDA will likely look at data holistically, not mechanically, in coming to a decision.
Colloquially, endpoints schmendpoints! Or, for those who remember the Rocky Horror Picture Show: "Dammit, Janet," use the Cox model.
First, readers might want to refresh themselves on the actual breadth of phrasing of the "likely benefit which outweighs risk" language:
"Based on the totality of the scientific evidence available to FDA, ...
...it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, ...
...and when used under such conditions, the known and potential benefits of bamlanivimab outweigh the known and potential risks of the drug"
Second, note the listing and detailing of every trial. Third, peruse some of the charts around page 20. No way this granularity is embedded in the original endpoint definition.
So, yes, thank you, this is a great example suggesting that in an EUA filing, as distinct from an approval filing, the FDA will likely look at data holistically, not mechanically, in coming to a decision.
Colloquially, endpoints schmendpoints! Or, for those who remember the Rocky Horror Picture Show: "Dammit, Janet," use the Cox model.
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