I'm sure the US FDA will have a nice 3 day weekend like the 4 days at Thankgiving and another 4 days at Christmas. A little pandemic means little to them, as we can all easily see.
Excellent news here. Makes sense to make this modification after the 14-day results.
The PR however does not say if this protocol change is for the CD-16 trial itself or for a separate trial that will start even later; whether CD-16 has already started and hence cannot be subject to this change; whether Cytodyn is going to stop enrollment and wait for the FDA to first approve this protocol change, etc. We don't know how much time it will be before FDA okays this change. Also this means Cytodyn likely would not include the past OLE data.
Time is ticking. I hope the FDA quickly approves this change and discounts the CD16 patients who only got 2 doses; and we can restart it with this new protocol.
Looks like Nader is keeping pressure on. Will be interesting what FDA does now... wonder if now they will just grant EUA because they know what the extra doses results will show.
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