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HM - 10 years away?


#21

Thanks for finding that!

Now they’ll likely patent the process using dimethylpolysiloxane.

As I see it, this is not a medical procedure (for which a patent can’t be protected from other doctors using it), but a process for making hair follicles in vitro. The point is, if it’s determined to be a lab process rather than a medical procedure, the patents CAN be legally protected from competitors. That would encourage investors to step in and finance clinical trials and developing the procedure into something that can licensed and sold to doctors and their patients. The first rule of investing in biotech is you have to have guaranteed return on investment, and that means you have to show that you can bar competitors from selling the same thing.


#22

yes is not.
dr As a question for bht


#23

Can you explain the permissible level of deviation to avoid patent infringement for a growth formula (ie., what ingredients to use, and how much) versus a culturing procedure (i.e., what tools or machines the formula goes into to produce an implantable HGF, or 5000 HGFs). In other words, if a physician develops a culturing technique in his own lab, and with this new knowledge of the necessary ingredients, figures out how to successfully make limitless implantable follicles, at what point would he be crossing the line if he set up his own shop and started performing HGF procedures?


#24

10 years? Sounds like more fake news. They don’t anything concrete, only theories. If this was real, with the demand, finding an investor would not be an issue.


#25

I would go even further. If I today could show technique how to turn NW6 to NW1, I would not look for “big” investor. I would go to any bank and I would secure business loan, say 50 thousands.
I would spend that 50 thousands for advertising and crowdfunding and in one week there would be 5 millions on my account. I would open small size clinic in countries like Somalia or Afghanistan and there would be myriad of americans willing to travel to those countries to have this procedure.
I think it is not funds, regulations or patents that matter most. It is LACK of RESULTS that hinders the progress.


#26

Otter,
I think you are 100% correct!. Most of this stuff is nothing but click bait. Saying it is 10 years out is the same as saying we don’t have a clue! Saying with confidence it is 3 to 4 years out you can bet they are on to something!


#27

That’s not even true, because we have heard predictions from companies many times just like that. Aderans and Intercytex, as well as Follica and most recently, Replicel, regularly made announcements “with confidence” (whatever that means) that they’d have a procedure available on the market in specific amounts of time… we’ve heard everything from “1 year” to “2 years” to “3-4 years”, and very often “5 years”.

These companies are not magic, they are not performing with magic wands, and everyone just has to use their own knowledge and common sense to determine what is credible and what is likely BS and click bait.

Dr. Fukuda’s claims as well as the form of procedure he’s using, to mass produce hair follicles in the lab from constituent cells, appear to be credible. But even Dr. Fukuda allegedly said it’ll be “10 years” before this is on the market. Yet he already has a patent for a large part of the procedure.

If that’s what he really said, and it’s not just some reporter putting words in his mouth, that can only mean 2 things:

  1. He’s giving an honest projection of how long it will take to get this whole thing through the regulatory authorities. Yes, Japan has fast-tracked and streamlined its regulatory process. But remember, this particular procedure involves using human stem cells, which are the most strictly regulated “biological” around the world. Part of the strict regulation of stem cells around the world is that the US FDA has actively influenced other countries’ policies, by meeting with them and attempting to coordinate and synchronize regulations, in an effort to control what they regard as fraudulent claims by many clinics promoting stem cell “cures” to a lot of diseases, and also the fact that stem cells from certain sources (such as embryos) are very controversial especially with the US religious community – which has held back stem cell research in many areas (although I don’t know where Dr. Fukuda is getting his stem cells from – are they HF stem cells?);

OR

  1. Dr. Fukuda may be trying to distract or discourage potential competitors by predicting this technology will be successful only in “10 years”. He may be a lot closer to clinical trials and getting this on the market in Japan than that. It’s possible that his 10 year prediction is an intentional effort to exaggerate the problems he expects, so that others don’t try the same thing. That would give him a big jump on everyone else.

I’d like to think I’m wrong about the above, but I think these are the 2 most likely possibilities.


#28

Let me rephrase “Saying with confidence it is 3 to 4 years out you can bet they are on to something”. If they show pictures of hair growing on a completely bald person using the specified discovery, then they might be on to something! Roger, you are correct! George Cotsarallis ring a bell?


#29

Dr A, we will have a breakthrough treatment this June or July ?


#30

@Dr_Arvind what are you working on?