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Msg  34518 of 35725  at  9/23/2020 1:07:54 PM  by

skimklaw


 In response to msg 34464 by  libertyhound
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Re: RLFTF Having Nice Day

 According to presentation 9/17 they filed for EUA, seems like maybe word leaked causing sustained rise starting 9/17.
 
Today with PR about EUA application.
 
FDA doesn't usually approve with case series vs standard of care group review as noted in presentation that 300% more likely to survive, but given case control is in same ICU with same ICU teams, seems better than an oncology study comparing study patients to 3 prior years of patients.
 
Javitt seems connected, seems strange to apply with this low level of evidence (case series) unless already had discussions of lets get this drug to sick patients, phase 3 data will be incoming in a month.  Not sure if FDA says wait or month or lets them move forward.  
 
From the front line, it is painful to wait a month, disease is endemic now.  People dieing, also taxing critical care resources and viral/flu season starts to arrive. 


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