"Conditional" EUA could be redundant, or perhaps t
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Posted On: 03/18/2021 3:03:16 PM
"Conditional" EUA could be redundant, or perhaps the EUA is applicable only during the emergency (Covid), but is *also* contingent or conditioned on confirmatory CD16 trial. If CD16 trial fails, then the EUA could be rescinded (independently of whether or not there is a Covid-19 emergency).
BTW, all the very vocal SA detractors keep saying no EUA could be filed based on CD12, while the company appears to be saying, yes they did file EUA.
Another thing I'd like to have cleared up, is which of the subgroup analyses were pre-specified in the SAP? FDA would be more likely to accept the subgroup analyses if they weren't cherry-picked ones post-hoc.
We're often left to speculate. Clarity should be forthcoming Monday on at least the above two issues.
The third important clarification is what exactly is the FDA's beef in RTF regarding RO for HIV combo therapy.
Three things we should learn about soon.
OK, CD16 status, long-hauler's status, and lots more to hear about.
I like these frequent calls to answer questions, as long as we keep having news to report.
BTW, all the very vocal SA detractors keep saying no EUA could be filed based on CD12, while the company appears to be saying, yes they did file EUA.
Another thing I'd like to have cleared up, is which of the subgroup analyses were pre-specified in the SAP? FDA would be more likely to accept the subgroup analyses if they weren't cherry-picked ones post-hoc.
We're often left to speculate. Clarity should be forthcoming Monday on at least the above two issues.
The third important clarification is what exactly is the FDA's beef in RTF regarding RO for HIV combo therapy.
Three things we should learn about soon.
OK, CD16 status, long-hauler's status, and lots more to hear about.
I like these frequent calls to answer questions, as long as we keep having news to report.
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