I am participating in the US clinical trial at the present time. I just finished the 4 month double blind trial. At the end of the the 4 months the participants were given the opportunity to continue for 9 more months knowing that they are taking the actual drug (no chance of the placebo) and the dosage amount. During the 4 months I am certain that I was receiving the placebo. I noticed no effect at all, including some of the common side effects ( headache, sinus pressure, flushing, etc. that I usually felt with the other ED drugs on the market. I just started the extended trial. The first time I took the drug, it was effective. After 4 month of nothing, it was quite a contrast. I know for sure that this will be a useful ED drug when released on the market. As far as the timing, I don't know if it will be released soon, or if they will wait until the 9 month extended trial is finished, which would put it around the end of 2010.