“Does the company need to officially submit something for FDA approval following unblinding or does that happen in accordance with primary endpoints being met following completion of the phase 3 trial?”
Yes, CYDY will need to file for EUA with the CD12 data. There is no way around that.
“Does the data need to be unblinded before the FDA makes a determination?”
Yes, the data will need to be unblinded, analyzed, and sent to the FDA as part of the EUA application. Do not buy into the hype that the FDA is actively reviewing the data because that’s a fallacy. Amarex and CYDY will be the first one to see the results of the trial, not the FDA.
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