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Posted On: 03/22/2021 5:38:52 PM
Post# of 149005
Recap they sound tired.
Recap CD12 relative delta 24% more mortality in placebo, amongst best results reported.
Age stratification against CYDY. Age adjustment stat sig in sub pop no authorization on these sub groups.
New accouncement slide 2 EUA FDA they have filed request.
Filed request for conditional EUA - CD16 and new trial over 65 IV first dose and 2 SQ doses.
OLE ongoing
Mhra UK accelerated rolling review.
EMA planning
Canada timeline filed for interim order.
Philippines CST - not injected after few patients case may get stronger.
Brazil MAH being applied for.
Hungary
Recap CD12 relative delta 24% more mortality in placebo, amongst best results reported.
Age stratification against CYDY. Age adjustment stat sig in sub pop no authorization on these sub groups.
New accouncement slide 2 EUA FDA they have filed request.
Filed request for conditional EUA - CD16 and new trial over 65 IV first dose and 2 SQ doses.
OLE ongoing
Mhra UK accelerated rolling review.
EMA planning
Canada timeline filed for interim order.
Philippines CST - not injected after few patients case may get stronger.
Brazil MAH being applied for.
Hungary
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