Histogen Japan 2016?

Collapse
X
 
  • Time
  • Show
Clear All
new posts
  • lacazette
    Senior Member
    • May 2015
    • 396

    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?
  • TooMuchHairWontKillYou
    Senior Member
    • Apr 2015
    • 104

    #2
    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 :\

    Comment

    • lacazette
      Senior Member
      • May 2015
      • 396

      #3
      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 ^^

      Comment

      • Ziggyz123
        Senior Member
        • Feb 2015
        • 368

        #4
        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.

        Comment

        • JayM
          Senior Member
          • Apr 2015
          • 413

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

          Comment

          • GSD
            Member
            • Apr 2015
            • 75

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

            Comment

            • lacazette
              Senior Member
              • May 2015
              • 396

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

              Presented by: Gail Naughton, Ph.D., Chairman & CEOHistogen is a regenerative medicine company manufacturing and developing innovative therapies based on the ...


              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

              Comment

              • FearTheLoss
                Senior Member
                • Dec 2012
                • 1589

                #8
                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.

                Comment

                • lacazette
                  Senior Member
                  • May 2015
                  • 396

                  #9
                  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

                  Comment

                  • cratusg
                    Member
                    • Aug 2015
                    • 31

                    #10
                    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?

                    Comment

                    • ShookOnes
                      Senior Member
                      • Jun 2014
                      • 213

                      #11
                      video, sharing, camera phone, video phone, free, upload


                      its recent. certainly doesn't look like its dead yet, especially with the new findings + congress presentations.
                      This should absolutely wreck replicel lol.

                      Comment

                      • jpar
                        Member
                        • Jul 2015
                        • 30

                        #12
                        I guess this is public knowledge now, but might as well point out the obvious histogen has got massive funding from a biotech venture capital start up seed funder they are not at phase 2 I heard they were basically done last year.. the only downside is their product isn't super amazing. It is good enough to buy though... I would throw down $1,000 on the treatment but definitely not around $2,000...

                        the only cool thing about it is.. it works once and keeps working through out the years

                        Comment

                        • allTheGoodNamesAreTaken
                          Senior Member
                          • Aug 2015
                          • 342

                          #13
                          Ah so there we go then, Histogen definitely is not dead, despite all these months of people saying it.

                          Comment

                          • Scientalk56
                            Senior Member
                            • Nov 2012
                            • 282

                            #14
                            Lol

                            Originally posted by lacazette
                            In their video presentation at the end of 2014 :

                            Presented by: Gail Naughton, Ph.D., Chairman & CEOHistogen is a regenerative medicine company manufacturing and developing innovative therapies based on the ...


                            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

                            Until the move thier ass, japans laws will change again

                            Comment

                            • 79BirdofPrey
                              Member
                              • Jul 2010
                              • 68

                              #15
                              I have been out of the loop. Where are the results from testing thus far? Thanks!

                              Comment

                              Working...