Histogen Japan 2016? - BaldTruthTalk.com
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  1. #1
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    Default Histogen Japan 2016?

    Well histogen said that they're doing their final clinical trial in japan.
    With japan's laws, that would mean they could have a limited approval there DURING this phase.
    And even sooner since the safety is already proven, no?

    What you guys think?

  2. #2
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    What do you mean in limited approval?

    I don't know what to say about Histogen, because they have been silent for a long time :\

  3. #3
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    With the new laws in japan about regenerative medecine, a company could have a temporary commercial approval with a solid phase 2, and already sell treatments, and of course continue the phase 3 for definitive approval

    look at this : http://www.google.fr/imgres?imgurl=h...ed=0CCEQrQMwAA

    They just need a confirmation of safety to have that limited approval !. (and anticipation of effectiveness, not confirmation)

    Its also said that they need less patients to prove effectiveness, and they evaluate safety on a shorter time period!!

    Japan will save us guys or give us a cancer lol ^^

  4. #4
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    Lmao, save us or give us cancer!!! That's good man. Yeah, can't say I've heard from histogen, but to travel that treatment isn't all that appealing. I'd just wait for replicel for the Japan release date.

  5. #5
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    Gonna go there, sell my kidneys on the blakcmarket and get them both done haha.

  6. #6
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    where histogen said that they do they final trial in japan? source?

  7. #7
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    In their video presentation at the end of 2014 :

    https://www.youtube.com/watch?v=WIM-vA6l0u8

    4.45 : 'So we're 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.'

    They could already have a temporary approval there with japanese laws, but they surely test the best doses, frequency, etc..

    It's not by accident that they go in japan for their final trial, it will be easy for them to commercialize it there sooner, and it's a great great new for us!

    It's really exciting, but we will have to travel to japan if we don't want to wait 2, 3 , 4 more years

  8. #8
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    histogen still doesn't have the funding to start their phase IIb..i would guess it's another 18 months, if ever, before they start phase IIb..unfortunate, but reality.

  9. #9
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    Where do you see that they don't have the funding please?

    And when they talk about "final trial" "late stage trial", you think they talk about phase 2B? and not phase 3? where do you see that?

    well in japan they could have approval with that phase 2B, so it could be the "final trial" they talk about but it sound weird

  10. #10
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    Do we know anything more about this? I saw a couple of people recently mentioning histo at the hairloss cure by 2020 blog so maybe there's something going on after all?

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