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Histogen's Presentation 2014 (video) thanks to noisette
Hello guys ! We have finally the histogen's presentation : Histogen - Company Presentation*: http://youtu.be/WIM-vA6l0u8
4:44 - 5:01
So We are moving forward right now with the strategy to do our final clinical trial for approval in japan, starting early next year for male pattern baldness and to go into phase 1 for women here in the US.
We are also actively looking for partners both here and Asia.
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Two questions:
1) How long will this final approval take before they can roll out the procedure for commercial use?
2) Can they get conditional approval for commercial release in Japan during the final clinical trial in accordance to Japan's new legislation for stem cells, or is their method completely different and does not apply?
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Senior Member
Great Idea for making an another thread on this video Thanks to you too Scientalk
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Originally Posted by hellouser
Two questions:
1) How long will this final approval take before they can roll out the procedure for commercial use?
2) Can they get conditional approval for commercial release in Japan during the final clinical trial in accordance to Japan's new legislation for stem cells, or is their method completely different and does not apply?
Well, that's a bunch of good important questions...
My question is will it be only phase 2b trial or phase 2b/3 trial...
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Senior Member
Vellus to terminal hairs. Music to my ears.
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japan is the future. glorius nippon
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Everyone was saying Histogen was dead. Goes to show that everything should be taken with a grain of salt, and this includes peoples pessimism on this board.
What kind of timeframe can we expect? 2016?
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I think that a product will likely be released in 2018 given that they have yet to complete a phase 3 trial (which will likely take at least a year) and/or license it, and have clinics open to provide a treatment.
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It sounds to me like they're saying next year they're doing the last clinical trial necessary for release in Japan and their clinical trials take about 1 year to complete so it sounds like they're saying that they'll be done with clinical trials for Japan the end of 2015 with release likely in late 2015 or early 2016.
This is what it looks like to me. But this looks a lot like AAPE and AAPE would be a lot cheaper.
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Originally Posted by hellouser
Two questions:
1) How long will this final approval take before they can roll out the procedure for commercial use?
2) Can they get conditional approval for commercial release in Japan during the final clinical trial in accordance to Japan's new legislation for stem cells, or is their method completely different and does not apply?
1 year for the trial +3-6 months for approval I believe, that's how it works with the FDA at least. My guess is Japan will be a little quicker to approve than the FDA takes, they are dreadfully slow.
so summer 2016? sounds about right, dont know about the 2nd question.
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