Replicel Is On Fire Lately — Data In Feb.

[That Guy]

Sorry i cant understand this. If i am a foreigner and have enough Money. Why i cant travel to Japan or Asia and get this f*****g procedure done.

Because it's possible the government regulations will not allow for non-Japanese citizens to undergo the treatment.

 

[itsjustsimon]

Because it's possible the government regulations will not allow for non-Japanese citizens to undergo the treatment.

Then somebody who’s not stupid and have enough money will buy an island and make it’s own country to save us baldies.

Oh f***.

 

[TK421]

Since the therapy is going to be a "conditional market approval" all of its participants will have to be recorded in a database and subject to possible follow ups, notified if sh*t goes bad, etc. by necessity.

Now, I can't find any info that wouldn't be in Japanese about the matter, but I could very easily see them not taking international patients for this reason. I could easily see them viewing international patients as too much of a liability given the record-keeping requirements, conditional approval, etc. and just refusing them outright. Ostensibly, this is just an extended clinical trial that is available to the public; consider that clinical trials are generally restricted to citizens or permanent residents of the country in question.

A lot of people here just can't see that perspective because they genuinely think this is something that is going to rake in billions, win nobel prizes, etc. and there's just no way the Japanese would do that — but that is incredibly naive.

So consider the following:

Tsuji and Shiseido are both going to be conditional approvals granting seven years before you have to provide necessary data to pass phase 3.

Let's say they both hit the market in 2020. It could very easily be 2027 before anyone outside of Japan can get it.

Well, I guess I'm screwed. I'll either be dead or bald in 7 years.

 

[Janks16]

View attachment 87951
Well, I guess I'm screwed. I'll either be dead or bald in 7 years.

Or you'll be married to a woman who digs you because there's chemistry, and she enjoys the pleasure of your company.

 

[itsjustsimon]

Or you'll be married to a woman who digs you because there's chemistry, and she enjoys the pleasure of your company.

 

[itsjustsimon]

View attachment 87951



Well, I guess I'm screwed. I'll either be dead or bald in 7 years.

It's all speculation. In reality, not a lot of people here have any idea about stem cell medical regulations and laws in Japan. We are just talking a lot of bullshit as always.

 

[Janks16]

I Will Be dead

With that attitude, it sounds like you already are.

 

[Feelsbadman.jpg]

Since the therapy is going to be a "conditional market approval" all of its participants will have to be recorded in a database and subject to possible follow ups, notified if sh*t goes bad, etc. by necessity.

Now, I can't find any info that wouldn't be in Japanese about the matter, but I could very easily see them not taking international patients for this reason. I could easily see them viewing international patients as too much of a liability given the record-keeping requirements, conditional approval, etc. and just refusing them outright. Ostensibly, this is just an extended clinical trial that is available to the public; consider that clinical trials are generally restricted to citizens or permanent residents of the country in question.

A lot of people here just can't see that perspective because they genuinely think this is something that is going to rake in billions, win nobel prizes, etc. and there's just no way the Japanese would do that — but that is incredibly naive.

So consider the following:

Tsuji and Shiseido are both going to be conditional approvals granting seven years before you have to provide necessary data to pass phase 3.

Let's say they both hit the market in 2020. It could very easily be 2027 before anyone outside of Japan can get it.

Shiseido has the license for RCH-01 for all of Asia, not just Japan. These laws are for Japan only. It will be available to foreigners well before 2027. We don't even know if foreigners are excluded from Japan. All of this is just speculation.

It could very well be that not EVERYONE who gets the treatment will be studied and "followed" up with. Typically phase III trials only use up to 3,000 participants and they will be offering this to a lot more than just 3000 people. If not, then this is not commercialization and not a "conditional market approval".So it may very well be that you MUST be a Japanese resident to participate in the Phase III follow ups. Non Japanese patients may still be able to get the treatment but they just won't be utilized for data collection purposes.

In other words, no one knows at this point.

 

[Kagaho]

Replicel Phase 1 study wasnt a good one. They only had a 60% success rate and very variable level of effectiveness. That makes me skeptical about Shiseido as well.

Lets hope the japanese find a way to increase those numbers

 

[hanginginthewire]

Replicel Phase 1 study wasnt a good one. They only had a 60% success rate and very variable level of effectiveness.

Yes. People gloss over those troubling facts with regularity on this board. Hope springs eternal.

 

[itsjustsimon]

Replicel Phase 1 study wasnt a good one. They only had a 60% success rate and very variable level of effectiveness. That makes me skeptical about Shiseido as well.

Lets hope the japanese find a way to increase those numbers

Sure about that?

The top 10 participants reported at least a 5% or greater increase in hair density at six months post-injection with an average increase of 11.8% (as reported in the May 17, 2012 announcement). This group demonstrated a sustained response at 24 months which averaged a 4.2% increase over baseline hair density. While there was a high degree of variability in hair density between individual participants at 24 months post-injection compared to baseline, an overall stabilization of hair loss was observed among all the patients treated per protocol.

 

[hanginginthewire]

Yeah, “per protocol” being the operative words. Anyone can run a study, then toss out the results they don’t like under some dubious claims of not following “the protocol.” Like, helloooooo, they’re the ones running “the protocol.” The “protocol” nonsense is just slippery machinations to explain away the results they don’t like imo.

 

[itsjustsimon]

Yeah, “per protocol” being the operative words. Anyone can run a study, then toss out the results they don’t like under some dubious claims of not following “the protocol.” Like, helloooooo, they’re the ones running “the protocol.” The “protocol” nonsense is just slippery machinations to explain away the results they don’t like imo.

 

[Kagaho]

While there was a high degree of variability in hair density between individual participants at 24 months post-injection compared to baseline, an overall stabilization of hair loss was observed among all the patients treated per

It was a small study, and there were female participants as well.

Shiseido trial is a different thing. We'll see.. lets hope for the best

 

[Ollie]

Yeah, “per protocol” being the operative words. Anyone can run a study, then toss out the results they don’t like under some dubious claims of not following “the protocol.” Like, helloooooo, they’re the ones running “the protocol.” The “protocol” nonsense is just slippery machinations to explain away the results they don’t like imo.

How dare you, come on this forum and utilise logic and rational that as a result crushes our delusion

 

[itsjustsimon]

How dare you, come on this forum and utilise logic and rational that as a result crushes our delusion

Yup I'm sure you mean that kind of logic and rational you and a couple of other fanboys defined in Brotzu thread...

 

[Ollie]

Yup that kind of logic and rational you and a couple of other fanboys defined in Brotzu thread...

You mean the lotion thats coming out in a couple of months and is a better alternative to those that dont want to take finasteride and lose function of their penis ?

Take it you wont be buying it then regardless of its outcome.

 

[That Guy]

Shiseido has the license for RCH-01 for all of Asia, not just Japan.

Which is likely good for years, if not indefinitely — there really is no rush.

It will be available to foreigners well before 2027

You know this, how?

We don't even know if foreigners are excluded from Japan.

You know it will be available to foreigners before X year, but you don't know if foreigners are excluded from the conditional approval?

It is impossible for you to know one of these things but not the other.

All of this is just speculation.

Speculation to which right now, an objective, government-enforced answer exists.

Just because neither you or I know at present, and it may be difficult to find out, doesn't mean the speculation is useless to a pertinent detail surrounding this.

There are perfectly sound reasons to suspect the answer is not in our favour

 

[That Guy]

How dare you, come on this forum and utilise logic and rational that as a result crushes our delusion

My god, you are insufferable with this sh*t.

No, the term "per-protocol" in medical trials literally means "the patients who followed the protocol for the procedure exactly as stipulated"

Because why the f*** would you consider the patients who failed to follow the instructions?

I hate to break this to you: But they actually know what they're doing here. They are going to throw out results that didn't follow the instructions, even if those results were still good, because it's the per-protocol patients that you need to convince the FDA and such that it works and is safe.

 

[Ollie]

My god, you are insufferable with this sh*t.

No, the term "per-protocol" in medical trials literally means "the patients who followed the protocol for the procedure exactly as stipulated"

Because why the f*** would you consider the patients who failed to follow the instructions?

I hate to break this to you: But they actually know what they're doing here. They are going to throw out results that didn't follow the instructions, even if those results were still good, because it's the per-protocol patients that you need to convince the FDA and such that it works and is safe.

You've quoted the wrong thing.