“Based on everything they just said, then WHY ar
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Posted On: 08/23/2020 6:29:41 PM
“Based on everything they just said, then WHY are we still sitting here 2 weeks later awaiting an answer on EUA??”
Here’s the problem: our EUA is for M2M population and not for the severe/critical population. Plasma was approved for those at risk of becoming sever/critical and to reduce the death rate (or at least that’s how I interpreted the FDA document). To be clear, there isn’t a good treatment for the M2M population (Remdesevir is basically an over hyped tamiflu) and I’m hopeful the EUA will approved, but it doesn’t seem likely.
The concern is obviously for the severe/critical population and only data from CYDY’s severe trial, not the M2M trial, will demonstrate a reduction in hospitalization and mortality. We may get interim data from the 195 patients In late September of CYDY can meet that 195 mark this week.
Here’s the problem: our EUA is for M2M population and not for the severe/critical population. Plasma was approved for those at risk of becoming sever/critical and to reduce the death rate (or at least that’s how I interpreted the FDA document). To be clear, there isn’t a good treatment for the M2M population (Remdesevir is basically an over hyped tamiflu) and I’m hopeful the EUA will approved, but it doesn’t seem likely.
The concern is obviously for the severe/critical population and only data from CYDY’s severe trial, not the M2M trial, will demonstrate a reduction in hospitalization and mortality. We may get interim data from the 195 patients In late September of CYDY can meet that 195 mark this week.
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