EUA is still very much on the table for Moderate.
Post# of 148181
(Total Views: 492)
Posted On: 09/17/2020 1:20:18 AM
EUA is still very much on the table for Moderate. This is perfectly in line with the PII results... not much signal was seen with patients below a baseline 4 on the clinical scale. "Approval" means all the studies are wrapped up, CytoDyn submits the request, they get scheduled a PDUFA date, six months later etc etc etc.
With the criteria established that just Moderate, > 4 clinical are being examined, with NEWS2, viremia, and a host of Cytokine markers are the endpoints, along with clinical improvement, any indication of effecacy in a Moderate PIII trial will justify EUA for that population. Neither the US nor UK would overlook that.
2. Jury is out... depends on how clear the interim results are. Sounds like the UK is considering it.
3-6: check
7: ....
8: not if it doesn't pass
S/C is the next catalyst. Another Buying Opp.
With the criteria established that just Moderate, > 4 clinical are being examined, with NEWS2, viremia, and a host of Cytokine markers are the endpoints, along with clinical improvement, any indication of effecacy in a Moderate PIII trial will justify EUA for that population. Neither the US nor UK would overlook that.
2. Jury is out... depends on how clear the interim results are. Sounds like the UK is considering it.
3-6: check
7: ....
8: not if it doesn't pass
S/C is the next catalyst. Another Buying Opp.
(3)
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