See what I mean! Your statement is pulled directly from some article likely quoting an anonymous source. “What i say” is a reasonable extrapolation based on the fact that this has been in early research for almost a decade now and is projected (in a very recent announcement) to begin human trials this year or early 2020. And then incorporate what I know about The processes of clinical trials How time consuming and volatile they are, find me a large scale clinical trial where phase I was fully completed and a phase II was nearly completed ( necessary requirement for the Japanese Cellular oversight committee to allow “conditional commercialization“ A.k.a. early access undoubtably marked up) in one year! Good luck.
Just to give you a Little perspective, this is what it is like for pretty much all western countries, Japan used to operate pretty much the same way until they implemented the brilliant idea of keeping pharmaceuticals and cellular based therapies separate and overseen by different administrations.
- Phase 0 of a clinical trial is done with a very small number of people, usually fewer than 15. Investigators use a very small dose of medication to make sure it isn’t harmful to humans before they start using it in higher doses for later phases.
- During phase I of a clinical trial, investigators spend several months looking at the effects of the medication on about 20 to 80 people who have no underlying health conditions. 70% make it through this phase.
- Phase II of a clinical trial involves several hundred participants who are living with the condition that the new medication is meant to treat. They’re usually given the same dose that was found to be safe in the previous phase. ( in Japan they would need to be pretty much near completion of this phase for when they can begin offering treatment early to the lucky few, keep in mind this means no adverse reactions, no investor fallout, etc. All of which can lengthen any part of a clinical trial indefinitely). Investigators monitor participants for several months or years to see how effective the medication is and to gather more information about any side effects it might cause. 30% make it through this phase.
Sources:
https://www.healthline.com/health/clinical-trial-phases#phase-i
https://www.centerwatch.com/clinical-trials/overview.aspx/
P.s even if it was a direct quote from Dr. Tsuji... are you living in some paradise where scientists never make overzealous projections for when their research will be complete and ready for market release?
There is just one example for you of someone saying it’s coming out late 2020, despite the fact that human trials have not even begun enrolment for chrissakes! But some article said here by 2020