Histogen and Replicel : stem cell meeting on the Mesa

[Haircure]

when news like this came up in 2012 people on this forum would never stop asking what the timeline had become at that time.. It seems to me ppl are afraid to ask that question now hehe, so here I go:
What are your opinions on what the timeline looks like for both these rejuvenating treatments after these presentations?

I just don't get what Japan has to do with Histogen's final phase.. what does all that mean? Is it included in the FDA approval process?
And how about Shesheido, how do they help in bringing the product to the market sooner?

As far as I'm aware, histogen has nothing to do with japan at this point but are looking for partners there. Shesheido is the Japanese partner to Replicel, and are developing the same hair loss treatment that Replicel is but, due to the new clinical trial laws recently implemented, they are able to do their trials faster.

[Gjm127]

As far as I'm aware, histogen has nothing to do with japan at this point but are looking for partners there. Shesheido is the Japanese partner to Replicel, and are developing the same hair loss treatment that Replicel is but, due to the new clinical trial laws recently implemented, they are able to do their trials faster.

But the question becomes : How do they benefit from Japan's new fast-tracking clinical trials? How does that translate to the FDA process? Would Histogen be able to sell in the US if they complete the development in Japan?

I though I heard Gail say that they were going to do the final clinical trials in Japan. Replicel only has a partner in Japan.

[hellouser]

But the question becomes : How do they benefit from Japan's new fast-tracking clinical trials? How does that translate to the FDA process? Would Histogen be able to sell in the US if they complete the development in Japan?

NO. This has been discussed a number of times. Any trials happening for any biotech must be done in accordance with FDA regulations for FDA approvals, thus a US commercial release. Having said that, screw USA. We don't need the FDA's approval if we can get a much faster release of a medical treatment in Japan. Even if it got approved in USA, it wouldnt happen for years after. Don't have any faith in the FDA, they don't give a crap about you, your health or your hair loss. They're not in the business of helping people... if it were the case, things would be very different.

I though I heard Gail say that they were going to do the final clinical trials in Japan. Replicel only has a partner in Japan.

That they are, but they have nothing to do with Replicel. AFAIK, Histogen has always been doing trials in Asia for a faster release seeing how USA is a joke. Good on them, they'll have my money much faster than if they were to chase a pipedream of releasing a treatment in USA.

[Haircure]

But the question becomes : How do they benefit from Japan's new fast-tracking clinical trials? How does that translate to the FDA process? Would Histogen be able to sell in the US if they complete the development in Japan?

I though I heard Gail say that they were going to do the final clinical trials in Japan. Replicel only has a partner in Japan.

From what I remember from the recent video, histogen is looking for partners in Japan but doesn't have any.

As for Replicel, having a partner in Shesiedo from Japan simply means that Shiesido controls the Asian and Japanese market and can license it to those areas. They can also release it earlier due to new clinical trial regulations, but that doesn't mean that treatment would be available anywhere else except those Asian countries. Replicel on the other hand has to deal with FDA in order to release it in U.S.

[Kiwi]

How do they benefit?

There are millions of balding people in Japan. Who cares about suckers in the USA. America has the FDA system and government they voted into power... and now Americans have to wait while Asia gets it first.

Histogen is going to beat Replicel to market because they are about to begin final testing and Replicel still have more rounds of testing to go to even get to where Histogen are at.

Hope that helps. Naturally you'll be able to travel to Japan and get your Histogen from there. So it's not such a worry

[Scientalk56]

when news like this came up in 2012 people on this forum would never stop asking what the timeline had become at that time.. It seems to me ppl are afraid to ask that question now hehe, so here I go:
What are your opinions on what the timeline looks like for both these rejuvenating treatments after these presentations?

I just don't get what Japan has to do with Histogen's final phase.. what does all that mean? Is it included in the FDA approval process?
And how about Shesheido, how do they help in bringing the product to the market sooner?

Histogen Final phase in japan means an early release of their product in Asia, But they would still need to conduct phase 3 to get FDA approval..
The question is, what did they mean by "Final phase".. Phase IIb only or Phase IIb/III..
Early release of their product i guess equals earning Millions if not Billions...

Btw, Histogen do need partners, but they will conduct their final phase anyway with or without partners, they already finished two phases with no partners..

[Gjm127]

thanks for the answers guys, I'm just wondering why no one asked them when they think they'll release the product and what the final phase means....
travelling to japan every 6 weeks is going to be pretty expensive guys....

[Scientalk56]

thanks for the answers guys, I'm just wondering why no one asked them when they think they'll release the product and what the final phase means....
travelling to japan every 6 weeks is going to be pretty expensive guys....

I asked them, no response...

[JimmyHairte]

I applied for the Replicel trials in Germany earlier today. Not sure what the chances are. Let's hope for the best, although I'm not too optimistic.

I will keep you posted though.

[hellouser]

I applied for the Replicel trials in Germany earlier today. Not sure what the chances are. Let's hope for the best, although I'm not too optimistic.

I will keep you posted though.

Not a chance, you can bet both your testicles that the signups for the trials are complete as they're moving along with Phase II within a few months. Sorry dude.