The fact that they’ve licensed the cell-based hair growth technology to Shiseido, a Japanese cosmetics company which sells skin creams, to me doesn’t suggest that their technology actually does much in terms of growing new hair. They may have determined that its likely best effect is to slow down the balding process, like a cell-based version of Rogaine. We’ve seen ZERO evidence that this stuff actually grows cosmetically significant amounts of new terminal hair on bald or balding scalps. So my guess is that it may be more helpful (if at all) in slowing down balding.
NONE of their experimental results and announcements have suggested it grows significant new hair, and if any company would be shouting this from the rooftops, it would be Replicel.
Japan has different laws and a different regulatory environment than the US, and its companies often take more risks than American companies, and are more willing to venture “outside the box”, so I don’t think such a deal could have been possible to, say, license a cell-based hair growth product to a US-based cosmetics firm. (The reason their companies can take more risks, by the way, has to do with the relationship between companies and shareholders in Japan. In the US, public corporations are often restricted tightly in what they can do because of fear of shareholder lawsuits for misspending money, whereas in Japan, there is much less such litigation and less fear on the part of corporate boards, so they are more free to take risks if they want to. A counterbalance against that is that Japan is not a naturally risk-taking culture, but if they really want to take a risk, they can).
So a US cosmetics company would probably license a chemical-based hair loss treatment, but not a cell-based one like Replicel. And apparently Japan has no big regulatory prohibitions against this kind of thing.
Replicel has a very good business game, they look for opportunities around the world WHEREVER they can find them… First clinical trials in the Republic of Georgia, of all places, cell culturing in Austria and Germany, etc. So it’s not surprising they might turn to Japan for a marketing opportunity. These days with markets being so globalized, they may be counting on the technique becoming popular in Japan and through that, leveraging it to persuade US and other Western regulators to approve it, something they might never have done if it weren’t first proved safe (and maybe marginally effective) in a more flexible regulatory environment like Japan. I think they’re betting this might give them a leg up on getting it approved in the US, Canada and EU and elsewhere, and they might be right.
It looks good on paper but I have my doubts, Shiseido is a cosmetics company, they can probably sell, market and label anything that is slightly beneficial for hair as a hair regeneration product, they are not bound by FDA regulations.
So then you believe that cosmetic companies can just ignore FDA rules? LOL! The FDA was brought into existence in part because dangerous cosmetics were being dumped into the marketplace.
[quote][postedby]Originally Posted by HMorHT[/postedby]
It looks good on paper but I have my doubts, Shiseido is a cosmetics company, they can probably sell, market and label anything that is slightly beneficial for hair as a hair regeneration product, they are not bound by FDA regulations.[/quote]
Cosmetics company in Japan that is. I was in Asia once and they have all kinds of lotions and potions that claim to grow hair, it looks like regulations over there are minimal or non existent.
This is definitely a “Japan” thing. For a cosmetics company in the US or Canada to license a cell therapy for cosmetic purposes would be unheard of… If they tried to do a deal like this it would take 5-10 years to get through the FDA, assuming there was even a chance it would be approved at all.
Roger you’re making it sound as if it’s already known that the Japanese are going to allow this “cosmetic” cell treatment into the Japanese market shortly. I haven’t seen any announcements that the Japanese have agreed to allow cell implantation therapy to treat hair loss into the marketplace in the near future. I think it’s still years away in Japan.
Well, yes I’m kind of assuming that because I think they wouldn’t have gone ahead with the licensing deal if they weren’t confident the path was clear to get it on the market. Licensing deals where millions of dollars change hands don’t usually happen unless the parties are sure that their plans are guaranteed to actually happen.
Unless of course, this is some kind of virtual “PR” deal done just for a press release, where no money or only nominal money has been paid and there’s actually no certainty the terms can be fulfilled. That of course is possible but it’s rare. In the US, with our SEC laws for publicly-traded companies, depending on how they did it, it might be considered misleading shareholders.
Roger you’re not addressing the issue I’m raising. I already know that sooner or later Japan will allow cell implantation to treat hair loss. But you seem to be asserting that Japan will allow the treatment on the market as a cosmetic treatment in the very near future - as in a few months or something like that. I totally disagree with that.