RLFTF Having Nice Day | Biotech Message Board Posts
  • Here We Go Again: Apparently, it's just one of those years. We here in the Greater New Orleans Area now find ourselves "in the cone" for the 7th time this year. And while we more or less dodged bullets the first 6 times, it looks like this time Zeta is going to hit close enough to do damage. We can only hope it stays a relatively minor Cat 1 & weakens upon approach. But preparations are once again in order for those of us living along the central Gulf Coast. Members with family or other interests in the affected area are welcome to post on the new Hurricane Zeta Self-Help board we just set up. Good luck & stay safe! 

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Msg  34518 of 34931  at  9/23/2020 1:07:54 PM  by


 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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