Wednesday, December 30, 2020 12:18:56 PM
I was under the assumption that we were waiting for the
clinical data to be unblinded by the FDA after day 28 of 165.
only after the FDA looks at the data were we going to get a EUA.
I dont see anything different, The PR did not say the data would stay blinded for another 28 days. but did say
"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
Nothing has changed, I believe they(FDA) are viewing the data now!
JMO
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