Update From The God Himself - Dr. Takashi Tsuji

trialAcc

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I would never wear a hairpiece, I don't care how well made it is. Not everyone thinks like you, someone will pay it. I wouldn't pay that much for it either, but if I had a hundred million, I would pay one percent of it to get the treatment two years early. There are a limited number of spots available. If you're looking for a 100% guarantee that doesn't exist. Even after clinical trials are done you still won't have your guarantee that it will last for years and be safe long term. You'll have basically the same level of assurance that someone participating in the phase II trial will have, little more
This is exactly my point and why I think he has yet to get funding or a strategic partner. You can't create a business that targets "people with a hundred million who would take a shot" in a clinical trial. If they had any business sense at all they would recruit any man off the street with ideal characteristics for trials and preform them 100% free. With 10 proof of concept patients you'd get booked out very quickly.
 
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Pls_NW-1

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They never once said they would be giving us any data in Q1 2021, just that they would be closing a next round of funding.
Sorry then, I comprehended it wrongly then. I was expecting them to announce stuff after closing round. Thanks for pointing out!
 

trialAcc

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Sorry then, I comprehended it wrongly then. I was expecting them to announce stuff after closing round. Thanks for pointing out!
They might, or they could be waiting to finalize their business planning with the money and then make an announcement. This is all speculative, for all we know they had major setbacks on pigs and the funding fell apart. :rolleyes:
 

pegasus2

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This is exactly my point and why I think he has yet to get funding or a strategic partner. You can't create a business that targets "people with a hundred million who would take a shot" in a clinical trial. If they had any business sense at all they would recruit any man off the street with ideal characteristics for trials and preform them 100% free. With 10 proof of concept patients you'd get booked out very quickly.
They have laws in Japan about how they can recruit people for clinical trials. I don't have the link to it anymore, but the point is we don't know what they are planning to do. To me it isn't the clinical trial price that's a problem, it's the price at official market launch when they can start advertising that is the problem. Since there will only be a limited number of slots available they could probably charge a couple million for the phase II trials and still fill them
 

trialAcc

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They have laws in Japan about how they can recruit people for clinical trials. I don't have the link to it anymore, but the point is we don't know what they are planning to do. To me it isn't the clinical trial price that's a problem, it's the price at official market launch when they can start advertising that is the problem. Since there will only be a limited number of slots available they could probably charge a couple million for the phase II trials and still fill them
To me, that's completely backwards. There is massive stigma associated with being in clinical trials, thats why many trials have to actually pay people to take part. Now obviously this is a bit different because in the same fashion that you wouldn't need to charge someone with an untreatable illness/disease to get access to a trial therapy, people also want hair.

If I'm a person who would be thinking of doing a procedure like this (which I am in a lower price bracket), I'm not paying that money to be in the trials. I would however pay it to be real client #1 when I can see full documented proof that the procedure works at producing full and natural density. Then my bank account is open.
 

pegasus2

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To me, that's completely backwards. There is massive stigma associated with being in clinical trials, thats why many trials have to actually pay people to take part. Now obviously this is a bit different because in the same fashion that you wouldn't need to charge someone with an untreatable illness/disease to get access to a trial therapy, people also want hair.

If I'm a person who would be thinking of doing a procedure like this (which I am in a lower price bracket), I'm not paying that money to be in the trials. I would however pay it to be real client #1 when I can see full documented proof that the procedure works at producing full and natural density. Then my bank account is open.
What if they show you pictures of ten slick bald people with a full head of hair after phase I? Wouldn't that be enough for you? It would for me. I can't afford the 750k for hair, but if it was 100k I'd be begging them to take my money for a chance to have hair two years sooner than everyone else.
 

trialAcc

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What if they show you pictures of ten slick bald people with a full head of hair after phase I? Wouldn't that be enough for you? It would for me. I can't afford the 750k for hair, but if it was 100k I'd be begging them to take my money for a chance to have hair two years sooner than everyone else.
Yes but that's not what they'll be doing for a phase 1 safety test & proof of human concept test, otherwise that's exactly what I just said. The phase 1 test is going to be patches of hair on bald scalp, similar to the Stemson or Tsuji mice pictures. Would pictures of 10 follicles in one spot after 90 days encourage you to drop 750k if you knew nothing else about the science?
 

pegasus2

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Yes but that's not what they'll be doing for a phase 1 safety test & proof of human concept test, otherwise that's exactly what I just said. The phase 1 test is going to be patches of hair on bald scalp, similar to the Stemson or Tsuji mice pictures. Would pictures of 10 follicles in one spot after 90 days encourage you to drop 750k if you knew nothing else about the science?
Tsuji told you this, or someone else at RIKEN? I would have thought they'd do at least one full scalp procedure in phase I to show off. They should all be full scalp procedures. Preclinical would be just a one cm spot, then the clinical trials should be exactly what they are going to do in the clinic, otherwise it's not a true test.
 

Roeysdomi

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Tsuji told you this, or someone else at RIKEN? I would have thought they'd do at least one full scalp procedure in phase I to show off. They should all be full scalp procedures. Preclinical would be just a one cm spot, then the clinical trials should be exactly what they are going to do in the clinic, otherwise it's not a true test.
Make no sense to goo ful head of hair on first try.
So many thing could go wrong . They should do at first 1 square cm then see that there no weird reaction and the hair come out in normal direction and there is no ingrown hair which would be horrible .. they need to do baby step when its come to human . Until they prefect it .
 

pegasus2

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Make no sense to goo ful head of hair on first try.
So many thing could go wrong . They should do at first 1 square cm then see that there no weird reaction and the hair come out in normal direction and there is no ingrown hair which would be horrible .. they need to do baby step when its come to human . Until they prefect it .
Before doing a phase I they do a smaller safety test in humans. This will be where they test 1cm².

"Phase 0 involves exploratory, first-in-human (FIH) trials that are run according to FDA guidelines. Also called human microdose studies, they have single sub-therapeutic doses given to 10 to 15 subjects and yield pharmacokinetic data or help with imaging specific targets without introducing pharmacological effects. Pharmaceutical companies perform Phase 0 studies to decide which of their drug candidates has the best pharmacokinetic parameters in humans."
 

Roeysdomi

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Before doing a phase I they do a smaller safety test in humans. This will be where they test 1cm².

"Phase 0 involves exploratory, first-in-human (FIH) trials that are run according to FDA guidelines. Also called human microdose studies, they have single sub-therapeutic doses given to 10 to 15 subjects and yield pharmacokinetic data or help with imaging specific targets without introducing pharmacological effects. Pharmaceutical companies perform Phase 0 studies to decide which of their drug candidates has the best pharmacokinetic parameters in humans."
So stemson will do it as well? After the pig trails?
 

trialAcc

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Before doing a phase I they do a smaller safety test in humans. This will be where they test 1cm².

"Phase 0 involves exploratory, first-in-human (FIH) trials that are run according to FDA guidelines. Also called human microdose studies, they have single sub-therapeutic doses given to 10 to 15 subjects and yield pharmacokinetic data or help with imaging specific targets without introducing pharmacological effects. Pharmaceutical companies perform Phase 0 studies to decide which of their drug candidates has the best pharmacokinetic parameters in humans."
Sometimes in phase 1 they literally give people a single dose of a medication. For BAY & Kintor's KX they dosed the back/abdomen of patients with a single doage, no where near the scalp or hair for either one. I would be very surprised if phase 1 was anything more then a patch of hair.
 

pegasus2

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Sometimes in phase 1 they literally give people a single dose of a medication. For BAY & Kintor's KX they dosed the back/abdomen of patients with a single doage, no where near the scalp or hair for either one. I would be very surprised if phase 1 was anything more then a patch of hair.
Maybe, maybe not. Nobody here is going to be getting it regardless
 

pegasus2

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There are various types of human hair shafts, which play a role in protection from the outside world, perception, and social communication. The basic structure of the hair follicles that create each hair shaft is the same. The fate of this hair type is determined by the fetal body plan and is remembered by the dermal papilla. Planting hair follicles elsewhere does not change the fate of the hair species.

In other words, moving an occipital hair to the top of the scalp doesn't change the fact that it's resistant to miniaturization.
 
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