Pretty much already been done in Europe. They are kind of bypassing the FDA. Clone3/ITV-1 will likely see release in Europe first, and then the USA will have to fast track its approval stateside or suffer the wrath of thousands of people with HIV who will be screaming for ENCZ's product.
Now you're getting it.. Just keep on following that story line and you'll soon get how it works.. SPECULATION .. FUTURE OUTLOOK .. "We may have this and if we do that ".. That's how it works.. They speculate and "imply" that these things are going to happen without giving any verification or factual evidence. That's how they get away with it.. FORWARD LEANING STATEMENTS as it's called by the SEC.. It means BULLSHIT in pennyland..