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Originally Posted by Arieux
@ lacazette: A user with nick Muhammad posted below the news ( http://www.hairlosscure2020.com/japa...do/#comments):
Is he right? It gave me a big hope, but I don't know exactly what this law regulation is saying. If this is truth they would be able to realize the plan of commercialisation it in 2018 despite their delay with starting the phase II trial.
I've been saying this for at least a year. Yes, it's true.
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Originally Posted by Arieux
@ lacazette: A user with nick Muhammad posted below the news ( http://www.hairlosscure2020.com/japa...do/#comments):
Is he right? It gave me a big hope, but I don't know exactly what this law regulation is saying. If this is truth they would be able to realize the plan of commercialisation it in 2018 despite their delay with starting the phase II trial.
Omg that would be awesome if he is right!! That could mean 1 or 2 years to see safety and they could get that limited approval.
Well for me it would be quite logical that when they say 'commercial use for 2018', they don't talk about 'limited approval'. But maybe Im wrong
But unfortunatly if there is a limited approval during phase 2, I don't think we could all travel to japan and get the treatment. Maybe it's gonna be just for a few people there for a 'real world trial'. But well I don't know anything so let's hope it's different with those laws.
The good point is that there's not only replicel that do trial in japan, so with their laws on stem cells, the new treatments for us are closer than we thought!
(I always liked japan's culture, but now Im just in loooove with that country haha)
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I think in terms of the limited approval it's more that they can only offer treatment to residents in Japan. I might be pulling that out of my a** but I think I read it somewhere.
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Originally Posted by JayM
I think in terms of the limited approval it's more that they can only offer treatment to residents in Japan. I might be pulling that out of my a** but I think I read it somewhere.
Omg it would be so frustrating !
Well if it's true, maybe it would be the moment for me to beggin a new life in tokyo hahah
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Japans new laws are made to boost economy, so there is no logic to offer their product only to japanese people
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One of the users (posting here:http://www.hairlosscure2020.com/spironolactone/) managed to contact Replicel and asked them about phase 2 and their presence during last dermatological congress. Here is their reply:
Thank you for your questions. We are still working towards conducting a phase 2 trial in Germany for RCH-01 and hope to have it started before the end of this year. You are correct about Shiseido, and we expect that they will be able to get their trial started ahead of the German start date. At this time, we will not be conducting a phase 2 trial in North America, only in Germany. If our phase 2 data is favorable, we will look to sell the data package to a much larger pharmaceutical company who has more experience bring products to market. They would need to conduct a multi-site phase 3 trial which would need to include North America if they wanted to sell RCH-01 in North America.
The Derm conference was a huge success. Two of our doctors, Dr. Kevin McElwee and Dr. Rolf Hoffmann both presented. I’ve attached a copy of the poster that Dr. McElwee presented, Dr. Hoffmann chaired a session.
I hope this answers your questions. I hope you have a wonderful day.
Kind Regards,
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Originally Posted by Arieux
There you have it, USA being a complete wasteland for clinical trials. Don't even bother with America's ridiculous regulations for new age medicine with stem cells. THANKS FDA!
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That makes sense. I guess sheishedo have the resources to sell ect in Japan to a big market. But it will be interesting to see who picks it up in North America.
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Does anyone know if Replicel would possibly be effective for enhancing facial hair? I have sparse blond hairs on my face and am not really close to being able to have a beard as too much of it is on my neck. If I could get the hair of my teenage years back plus a dope looking beard that would be a coup, to say the least.
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I hear minox taken orally grows hair everywhere. Maybe just apply to your beard area?
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