Phase I trials usually just test the safety issues in humans. Toxicity, dosage, reactions...The real testing starts in Phase II, dosage again, efficacy,...
Because CYGX's processes are a mechanism more than a drug as we normally
understand them to be, things like toxicity and reaction will be virtually nonexistent.
This will be established quickly. IMO, the sepsis phase I trial will be very short term.
The phase II trial will be quick also, because if it works as it did in mice it will
have to be pushed by the FDA. Phase III will probably run concurrently at some
point with Phase II. I predict the sepsis treatment will be in wide spread use
within 3 years. Because of the mortality rate of sepsis, sometime during phase II
when it's efficacy is already proved beyond any doubt, it will be used to treat
the most severe cases. Patience with nothing to lose.
