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Posted On: 02/16/2021 7:43:06 PM
Post# of 148925
Even though we all know CYDY was delayed because of trivial info on bla submission Nadar continues to speak highly of FDA - if he stated they wanted raw data before top line report done than I have to believe that’s what happened because if any delay it will make FDA look more horrible than they already do yet most of if not all blame previous administration. So this speeds things up exceptionally because I believe it would bypass normal protocol of submitting for EUA or it will have cut that time down and maybe we would see a applying for EUA on same say data is released however I am leaning towards FDA announcement out of blue without CYDY ever having to formally apply - CYDY sending them the raw data is basically their application for EUA. OLE is another way FDA has been able To evaluate safety and effectiveness of leronlimab. My hope Is they have been put to the front of the FDA line as it’s only phase 3 mortality reducing trial. As many others have stated even if CYDY has the raw data and could easily see the mortality data reduction I don’t believe they are in position to just PR it if raw data was sent to FDA. Under normal circumstance of top line report if data good announce applying for EUA, yet fda requests unblinded data right away sounds like sense of urgency and hopefully it’s the best thing we could ask for as no telegraphing of when EUA might come Creating worse possible situations for shorts.
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