"The FDA did not agree to grant EUA, as applied for in September, based upon the open-label study reported earlier, but has advised us that they remain committed to working with us in the development of our product and will promptly review the forthcoming data from this randomized trial. Until that time, available stocks of ZYESAMITM (RLF-100TM) will continue to be administered under our Expanded Access Protocol and individual patient requests under Right to Try laws."
Pretty straight forward to me. Might as well say denied as did not agree means same thing in my book. One good take from it is that least they're finally being open and honest about it.
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