I agree, without some solid coordination with the FDA, this would be a huge risk. For the M/M trial, they clearly discussed if they should file an EUA and were told not to, and that is what they did. It could be the frustration is so high that possibly the FDA is not approving the CD16 protocol and that was the last straw? I doubt it. I think there has been huge pressure on the FDA from many doctors to get an EUA ASAP. Is it odd that cytodyn would not put out a PR that they did in fact file EUA's before announcing a CC? Are they assuming the FDA will make some decision about the EUA (if filed) prior to the CC? Is this just a promised update CC and we are reading too much into it?
(most likely)