RepliCel Reports Progress on Shiseido Technology

[hellouser]

Could this really be available in 3 years?

3.25 years... but yeah.... it looks like the deregulation will make that possible. See chart below:

[joely]

Could this really be available in 3 years?

I doubt that it will be available that soon, their phase 2 trial is just about to begin which is over three years, i know they now have the whole Japanese thing happening now, just cant see a reputable company wanting to release a product after only a safety trial and possible small efficacy if they don't know it will work that well i don't think they will risk it!

[sascha]

I doubt that it will be available that soon, their phase 2 trial is just about to begin which is over three years, i know they now have the whole Japanese thing happening now, just cant see a reputable company wanting to release a product after only a safety trial and possible small efficacy if they don't know it will work that well i don't think they will risk it!

Aren´t they already in phase 2 studies in germany since 2013?

[Sogeking]

Aren´t they already in phase 2 studies in germany since 2013?

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

[sascha]

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

Thanks for clearing things up, man.
I just saw this article where it was written they want to start trials in germany(Charité Berlin) in 2013, so I was a bit confused.
To me it makes perfect sense what they did. The new trial in germany will bring 288 data points or so, compared with the roughly 16 data points from phase 1.
In the meanwhile Shiseido does a more practical study with access to the general public(with conditions). That is pretty smart. Asian men and women tend to treat their hair loss earlier and seem to care even more, of course members of hair loss forums care the most in my opinion.
But as you said, we will see

[Thinning87]

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

It's obvious that they will be working with repeated injections to improve results.

[hellouser]

Nope. They are supposed to start this year. But 39 months long phase 2 trial is really long. I mean they did prove safety with phase 1 trials, why go 3 years for effectivity(granted they are safety as well) trials?

I don't know I can only speculate we'll see how Shiseido plays it. But although Shiseido might get to market sooner, effectivity could still be downplayed...

Japan allows conditional commercialization during Phase II trials. It's possible they could release the product much sooner than 39 months.

[joachim]

Japan allows conditional commercialization during Phase II trials. It's possible they could release the product much sooner than 39 months.

that's true. if they see some good results after 1 year already then they theoretically could release it sooner. in case they are not satisfied with the results and want to try more dosing protocols etc. then they probably will stick to the whole time frame.
but i have a good feeling that shisheido is involved with separate trials, too. maybe they are eager to release it sooner if efficacy turns out to be useful. we should ask for a status update in 1 year or so to see what's their results and if they are thinking about an earlier release.

[Thinning87]

I think it's likely that the Japanese will want to run their own trials and study the product extensively. Keep in mind guys it is likely that the only reason why the Japanese even decided to buy the technology is that the longer time point outcomes were more positive than the ones published, and this demonstrated potential for improvement with different methods/protocols applied.

I deduce this from what spencer had said in an episode last year after speaking with Hall.

This all means for us that we are going to have to wait some time

[sascha]

https://www.shiseidogroup.com/ir/pdf/ir20130530_701.pdf They already wanted to conduct trials last year, with intention to get to market within 5 years -> 2018. Maybe with the new facility the timeline comes even down to 2016 for early release as hellouser already pointed out, because they still can make money and collect data points at the same time.