How long will each of the three FDA trials take? Will they take more or less than 10 years?

American Gene Technologies® cannot predict how long the FDA process will take at each stage of the human trial and approval process. The FDA clinical trials are meant to ensure the safety and efficacy of new treatments, so they will take as long as necessary. Since the trials do not have a predetermined duration, it is hard to predict when AGT103-T would be able to clear all three of the FDA trials, but it would be at least several years. AGT103-T is currently in Phase 1, and as data comes from the trial, American Gene Technologies will be able to predict the path to the market more accurately. It is possible that there could be limited commercialization three to four years from an efficacy signal, which could potentially even happen in the Phase 1 clinical trial. From there, it is reasonable to expect that it would take several more years for wide distribution.

However, there are no guarantees. There are many externalities on the route to launching a new drug (especially regulatory requirements of the FDA and other agencies worldwide) that are beyond our control and could cause delays. All of this depends on verifying that the cell product actually works in humans the way we expect it to. We are hopeful, but it needs to be proven in the ongoing human trial, so until that is concluded, we don't know for sure.