Replicel Interview w/ Dr. Rolf Hoffmann & Lee Buckler

Blackber

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Actually, there was an interview with David Hall a while back, I don't have the link, BUT, it looked like a TV news station with a desk and anchor. I do recall the question about costs being mentioned, and there was mention of it being competitively priced with hair transplants.

I actually had another brief discussion with Dr. Rolf Hoffmann and costs was something I asked about as well, and again, it would likely be around the price of a hair transplant. But we know hair transplants can vary in price from a few thousand to nearly $20,000 if going with someone like Dr. Rahal, but it's pretty safe to assume it'll likely be closer to the $6k - $9k range. HOWEVER, since Replicel itself won't be administering the procedure, they're not the ones that will be setting the price as the price will be determined by clinics, so it's still a bit early to tell what the price will really be. Let's just hope there are enough clinics that will adopt Replicel's technology with a race to the bottom that will benefit a wider consumer base; keeping the costs high will make it exclusive to the very rich.

There's also been some speculation that a similar treatment costs about $3,000-$5,000 but I don't remember what it was.

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:blush:

I saw that same "tv-anchor" interview. I'm not 100% sure but I believe the $3-5k number was mentioned in regards to the pricing of Replicels RCT-01 Tendon Repair Treatment. This tendon treatment uses the same/similar process as the Androgenetic Alopecia treatment so forum members were speculating that the cost would be around $3-5k for Androgenetic Alopecia as well.

It makes sense to me that similar treatments would cost the same but as David Hall said it's really up to the clinics that offer the treatment. I tend to agree with hellouser that it will be less than a hair transplant but I'm sure there will be a premium since its a much less invasive procedure.
 

hellouser

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Update:

Lee Buckler was just promoted as the new CEO of Replicel. David Hall is retiring.
 

Blackber

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Update:

Lee Buckler was just promoted as the new CEO of Replicel. David Hall is retiring.

Just did a google search and didn't see anything but I'm sure you're right.

Lee Buckler always seems knowledgeable and well spoken in all his interviews, his knowledge of the science behind their treatments is impressive as well considering he's a business/financial guy.

http://replicel.com/replicel-life-sciences-adds-industry-specialist-to-management-team/

It seems like Lee was brought into Replicel with an expertise in licensing deals (Shiseido). Sounds like he also has a lot of experience working with different biotech companies.

I think he's a good choice. Hopefully Replicel makes steady progress and we can go to Japan sometime in 2018.
 

Mach

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https://www.google.com/patents/US20150218520?dq=inassignee:"TrichoSciences+Innovations,+Inc."&hair loss=en&sa=X&ved=0ahUKEwigueu_re7JAhVG7iYKHaBfDZEQ6AEIGzAA

Interesting read but not sure it's exactly new. Replicel bought this company in 2010
 

Blackber

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since 2021/2022 is projected date, does that mean histogem is more in reach?

I suggest you listen to both interviews Hellouser posted on Replicel and Histogen. He put a lot of work into them for all of us.

No one knows for sure and anyone that says they do is making assumptions. After I listened to the Replicel interview it sounds as if they are shooting for 2018 in Japan but most likely 2019.

Histogen may be able to offer their product in Mexico sometime in 2017 as per Gail's interview.

All of this is assuming they don't run into any issues....
 

NewUser

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No one knows for sure and anyone that says they do is making assumptions. After I listened to the Replicel interview it sounds as if they are shooting for 2018 in Japan but most likely 2019.

I hope they don't have to finish out phase II trials, 39 months, before getting regulatory approval in Japan. I think mention of the length of phase 2, 39 months, is why some people are thinking rch-01 won't be on the market anywhere until 2020 or 2021.

But then I read this recently about Japanese government loosening regulations for biotech and new-er cell therapies. I'm just wondering at what point during phase II might probable efficacy be demonstrated?

Regenerative medicines in Japan can now get conditional marketing approval based on results from mid-stage, or Phase II, human trials that demonstrate safety and probable efficacy. Once lagging behind the United States and the European Union on approval times, there is now an approximately three-year trajectory for approvals, according to Frost’s Kumar. That compares with seven to 10 years before.

Three years? Okay a little arithmetic tells me phase I safety for rch-01 lasted 12 months, so that's one year. Two more years to round out the minimum three-year time to approval in loosey goosey Japan would mean 2018 at the earliest I think.

In Hellouser's interview with Replicel, Hoffman did say, and in a rather quiet but confident manner, that he doesn't think the cells need anything extra in response to hellouser's excellent question: Would a combo therapy of Histogen and RCH-01 produce ideal results? So their latest results were that good? It sounds to me as if they are confident that efficacy will be proven.
 

Blackber

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I hope they don't have to finish out phase II trials, 39 months, before getting regulatory approval in Japan. I think mention of the length of phase 2, 39 months, is why some people are thinking rch-01 won't be on the market anywhere until 2020 or 2021.

But then I read this recently about Japanese government loosening regulations for biotech and new-er cell therapies. I'm just wondering at what point during phase II might probable efficacy be demonstrated?



Three years? Okay a little arithmetic tells me phase I safety for rch-01 lasted 12 months, so that's one year. Two more years to round out the minimum three-year time to approval in loosey goosey Japan would mean 2018 at the earliest I think.

In Hellouser's interview with Replicel, Hoffman did say, and in a rather quiet but confident manner, that he doesn't think the cells need anything extra in response to hellouser's excellent question: Would a combo therapy of Histogen and RCH-01 produce ideal results? So their latest results were that good? It sounds to me as if they are confident that efficacy will be proven.

Good point. I'd have to listen to the interview again but when I listened to it originally I got the feeling that Hoffman alluded to it being more for maintenance and keeping what you have rather than regrowth. If it works I'm sure it'd help "damaged" follicles but I'm not sure what it's effect would be on completely miniaturized follicles. Again, it'd be nice if they released before and after pictures at some point.

I'm not as knowledgeable as other members but as far as I know they haven't released any pictures. Can anyone confirm that?
 

NewUser

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I'd have to listen to the interview again but when I listened to it originally I got the feeling that Hoffman alluded to it being more for maintenance and keeping what you have rather than regrowth.

I think the term maintenance is associated with older drugs for hair loss, like finasteride and minoxidil. I think we are witnessing the beginning of a new era for hair loss treatments. They will be targeting hair follicle stimulation, re-growth and even neogenesis or creating new follicles.

From Replicel's site:

The best defense is a good offense

In recent years the theme of the balding conversation has changed from “maintenanceâ€￾ and “preventionâ€￾ to actual regrowth. The reason? A better understanding of hair biology, including new knowledge of how cells communicate with the hair follicle.

It remains to be seen what kind of results are produced by Replicel's/Shiseido's clinical trials. As Lee Buckler said in the interview with hellouser, they will know a lot more about dosing levels, number of injections required and so on, within the next two years. iIf they can show probable efficacy, then they should have a product for licensing to dermatologists and hair clinics.
 

Blackber

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I haven't seen anything from Sheseido regarding commencement of their next clinical trial. Has anyone heard anything?
 

INT

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I applied for the clinical trial they will do in Germany. Does anyone already know when this trial will start?
 

Folliman

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No one knows when the trials will start, but we do know that Japan's trials are starting first. According to this, Shiseido's trials are expected to be announced in the first quarter of 2016. So, in about a month?
 

distracted

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Their 10-K will be available sometime this month. Hopefully that will include an update although I doubt anything has changed. They are probably still waiting regulatory approval to proceed.
 

CopeForLife

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Hope this comes out in our lifetime.

Anyway youth of most of us will be wasted. Getting full head of hair at 50 after 30 years of balding subhuman life will be a minor consolation anyway.

The only good outcome is next generation will be finally cured of this disease. Will be funny btw be the last bald generation.
 
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