Replicel Presentation in Toronto, Jan 29th 2016 - Japan Regenerative Medicine Market

[Folliman]

*sigh* They are injecting the patients own replicated cells. What the hell is there to regulate? stupid bureaucracy. I just hope whoever is reviewing the documents has hair loss and approves it...

 

[hellouser]

Also! http://replicel.com/wp-content/uploads/2015/02/JETRO-Toronto-RepliCel-in-Japan-a-Case-Study.pdf

Page 24 shows how Japan is going to categorize Replice's treatment for a 'conditional' approval (likely will play a role). It's also likely that it'll be 'Class III' as in low-risk, so it should be fairly easy to give the green light, although because it's a 'cosmetic' condition, who knows how seriously they take.

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Thanks so much Hellouser! awesome contributor!! did you get a feeling for how effective it might be at all? could this be a cure conceptually?

It'd be a functional cure for sure. Man, I wish we could see the 6+ month results, I've actually been talking about them for a good number of years. They'd be far more telling than just the 6 month results.

 

[stressftw]

Also! http://replicel.com/wp-content/uploads/2015/02/JETRO-Toronto-RepliCel-in-Japan-a-Case-Study.pdf

Page 24 shows how Japan is going to categorize Replice's treatment for a 'conditional' approval (likely will play a role). It's also likely that it'll be 'Class III' as in low-risk, so it should be fairly easy to give the green light, although because it's a 'cosmetic' condition, who knows how seriously they take.

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It'd be a functional cure for sure. Man, I wish we could see the 6+ month results, I've actually been talking about them for a good number of years. They'd be far more telling than just the 6 month results.

thats very good to news although this feeling of hope emerging is something very dangerous for us right now, i will try to be stoic about these good news, and thank you for the amazing work youre doing for us, it means alot

 

[logikmtr]

Thanks Hellouser! As much as I hate looking at my thinning hair in the mirror, I think it's a good thing that we have regulations to protect us against B.S. medical procedures and drugs. We have a lot in the pipeline to look forward to, and if any of these treatments do what they claim, the next few years will be good for us. Meanwhile, I started finasteride again :thumbdown2:. Party like it's 1997.

 

[INT]

In Replicel's latest newsletter Lee Buckler states that he still thinks that RCH-01 will hit the market in 2018 (in Japan).

 

[Swoop]

In Replicel's latest newsletter Lee Buckler states that he still thinks that RCH-01 will hit the market in 2018 (in Japan).

Damn.. That would be really sweet. Hope they just manage to get good results, that's the most important part.

 

[INT]

Copy:

About RCH-01: - Hair repair, Shiseido (Japan)
We anticipate Shiseido will announce the start of their clinical trial of RCH-01 in Japan in the first quarter of 2016. Shiseido has invested a great deal of time and money in continuing to optimize the product and its manufacturing with RepliCel, building, validating, and obtaining PMDA certification of its facility purpose-built for this product, successfully completing the transfer of the manufacturing protocols and the product manufacturing validations, selecting the clinical site, training all related personnel, and submitting the clinical protocol for Ministry review.

We believe that Japan’s unique regenerative medicine regulatory and industry environment provides a unique opportunity to rapidly advance this product in their country and are excited that RCH-01 has the potential to be launched in the Japanese market by Shiseido as soon as 2018.

Clinical data from Shiseido’s trial will be shared with RepliCel, further strengthening the data package created on RCH-01. This can be used in submissions to other regulatory agencies and in negotiating the license for this product for the regions outside of Shiseido’s exclusive territory.

Market: $3.5 billion was spent on hair loss treatments in 2015 according to the Washington Post and $2.5 billion of this was spent on surgical proceduresaccording to the International Society for Hair Loss. We believe RCH-01 has the potential to capture a good percentage of that surgical expenditure but also significantly grow the market because most hair loss sufferers still elect not to do surgery due to the invasiveness and variability associated with the procedure.

 

[I.D WALKER]

I've never lost my confidence in our Asian operative(s).

 

[Tracksterderm]

Yeah, I saw that newsletter too, and it is definitly exciting that they building and investing so heavily for this product. However, I thought they were going to start trials "within weeks" back in November.
So the target of 2018 is far ahead and I believe there will be setbacks and delays as with any project or product. So maybe on the market 2020 in Japan if things goes fairly well.

 

[hellouser]

Yeah, I saw that newsletter too, and it is definitly exciting that they building and investing so heavily for this product. However, I thought they were going to start trials "within weeks" back in November.
So the target of 2018 is far ahead and I believe there will be setbacks and delays as with any project or product. So maybe on the market 2020 in Japan if things goes fairly well.

Maybe Shiseido started the Phase II trials in Japan?

 

[Follisket]

This is what I don't understand about Replicel. In most interviews I've read, they paint themselves as an alternative to surgical procedures in the battle against hair loss. Yet the people who might consider getting a hair transplant don't really represent their market, do they? I mean, they're after new hair whereas Replicel has already made it more or less clear they can only offer maintenance.

So what's all that about? Is it just a clever marketing trick, trying to imply regrowth without actually having to claim responsibility for it, or what?

 

[hellouser]

This is what I don't understand about Replicel. In most interviews I've read, they paint themselves as an alternative to surgical procedures in the battle against hair loss. Yet the people who might consider getting a hair transplant don't really represent their market, do they? I mean, they're after new hair whereas Replicel has already made it more or less clear they can only offer maintenance.

So what's all that about? Is it just a clever marketing trick, trying to imply regrowth without actually having to claim responsibility for it, or what?

No, they've made it clear that they're after reversal of hair loss, not maintenance.

 

[youngkidwithhairloss]

I am really banking on Replicel and/or Histogen being at least able to maintain for a large number of years, any re-growth would just be an added bonus to me! If these treatments don't work out, I feel like that will basically seal my fate of being a bald guy for the prime years of my life. Please treatments, work!:$

 

[Norwood One]

Let these clinical trials due to start soon be a huge success, for all our sake.

That is my only wish for the next 2 years. Forget a Lamborghini and a Victoria secret Angel sex slave.

 

[Tracksterderm]

Maybe Shiseido started the Phase II trials in Japan?

Maybe... but RepliCel have been very much open and sharing information on any development with their products. I know Shiseido is a separate entity and may do things very differently, but why would RepliCel state that Shiseido will initiate trials in Q1 2016 if they had already started?

Anyways, I think it sounds promising that they are using money and resources as stated in the newsletter. Does indicate they are confident in their product/results.

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No, they've made it clear that they're after reversal of hair loss, not maintenance.

I have ofte seen people refer to Replicels RCH-01 as a product for maintenance, but from video on their website it does seem they are aiming for regrowth AND maintenance.

 

[hellouser]

Maybe... but RepliCel have been very much open and sharing information on any development with their products. I know Shiseido is a separate entity and may do things very differently, but why would RepliCel state that Shiseido will initiate trials in Q1 2016 if they had already started?

Anyways, I think it sounds promising that they are using money and resources as stated in the newsletter. Does indicate they are confident in their product/results.

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I have ofte seen people refer to Replicels RCH-01 as a product for maintenance, but from video on their website it does seem they are aiming for regrowth AND maintenance.

If you're getting regrowth, maintenance is redundant.

 

[INT]

Damn.. That would be really sweet. Hope they just manage to get good results, that's the most important part.

Offtopic: Swoop are you still on finasteride or back to only RU?

 

[distracted]

http://www.fdanewsalert.com/replice...cf-shorted-shares-increased-by-27-17/8515387/

Not what I want to be hearing...

 

[paleocapa89]

"RepliCel Life Sciences Inc (OTCMKTS:REPCF) has declined 58.33% since July 13, 2015 "

holy sh*t that is not good news.

 

[Baldybald1]

Another aderans ??