If I remember correctly, the FDA submission process was started by Jack, last years CEO and he was the one who got the intellectual properties patented. There has been a ton of work done since back then, but what I'm pointing out is that our Gunn has not gone into this venture fresh and green. He has years of data and experience with these submissions and all whilst being a top share holder.
I really like this guy and his passion for the work. If any1 can get this product out there, he is the man.
Ann: FDA Strategy and Regulatory Update, page-442
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