Cytodyn Inc (CYDY)

[Irishvox]

I’ve been working on a class 3 device for almost 5 years and it’s all regulatory hurtles. I’ve been through 3 different consultants independent and multinational firms everyone of them an “expert” in getting the ball across the goal line but in the final Analysis the FDA has not got a goal line is it really arbitrary process I fully understand the frustrations cytodyn is experiencing. I was a bit skeptical when Nadar indicated that they were being hand walked by the FDA through the process to prevent refusal to file because I have never heard of such an experience with them. It’s hard to explain what a meeting with the FDA is like and how they go out of their way to not give you any straightforward concrete advice or direction in the process it is entirely up to you to prove to them your hypothesis and outcomes. I believe 100% in the science of this drug, I believe 60% in the management (though less each passing month) and I have 0% confidence in the FDA. It amazes me in this time of need how obstructive they are to a company that has eight years of pristine safety data to not allow for emergency use authorization is almost criminal.