Replicel Is On Fire Lately — Data In Feb.

[00000]

Me: BTW I was sent back from the future to tell all of you that RCH-01 will be available in the United States before you are ready for it, and before Japan completes Phase 3...

You: Whaaa>>> how is this possible!! Nonesense!

Me: Lol. Okayyy

You: But what do you mean?? How can this be... What about FDA blah blah blah....

Me:

You: TELL US GAWD DAMMIT!!!!!!!! NOW!!!!!

Me:

You: YOURE FULL OF sh*t AND NO NOTHING!!!! LIAR!!!! STOP LYING!!!!

Me: If you say so bud

 

[Feelsbadman.jpg]

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

There absolutely is a rush. Profit. That is the whole point of being able to bring treatments to market in phase III, it incentives companies to complete the trial because they can reap profits much sooner.

You know this, how?

The same reason you know that it won't be.

Also some one already provided an example of this happening in Korea for another procedure in this very thread....

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 will be available to foreigners some where in Asia before 2027, provided that the phase II trials produce favorable results, but I don't know if foreigners are excluded from the conditional approval in Japan. This is pretty simple logic. Do you follow?

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

Please provide a reference for this objective, government-enforced answer as to whether or not foreigners will be allowed to participate in conditional market approval for RCH-01 in Japan.


Normally I agree with most of your posts That Guy but this was just sloppy and half assed.

 

[NewUser]

If it works, how would the all powerless FDA stop them from selling it in a country known for having had bogus stem cell therapies and catch me if you can witch doctors scamming the public? If it works at all, the FDA aint gonna stop it. If it works, then people will buy it with or without approval.

 

[razzmatazz91]

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.

I completely agree with you and I think the conditional market approval will be exactly that. If they had a product I don’t think they’d wait the full seven years but I cannot see this being available anywhere outside of Japan until the usual Phase 3 process is complete.

@kingjohn mentioned in a Tsuji thread that a arthiritis treatment was available in Korea right after Phase 2. How does that work?
Is @kingjohn atill here?

 

[hanginginthewire]

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.

But the issue with protocol here is on Replicel’s end, not the patients. At least the issue we know about - materials being stuck in the post/customs. Patients didn’t fail to follow instructions, rather, Replicel was sloppy and careless in administering the materials and in injecting cells. Injecting too many cells - Replicel’s fault. The other issues outside of protocol were only alluded to, so we don’t even know what they are.

At any rate I don’t get the impression that they are flawlessly marching towards release, it’s a lot of trial and error, guesswork, and, just like here, speculation. That’s not enough to run a railroad on, unfortunately.

 

[That Guy]

There absolutely is a rush. Profit. That is the whole point of being able to bring treatments to market in phase III, it incentives companies to complete the trial because they can reap profits much sooner.

There is no rush to bring it to other parts of Asia. Nothing indicates that right now.

The same reason you know that it won't be.

Also some one already provided an example of this happening in Korea for another procedure in this very thread....

I don't know when it will be available to the rest of the world. So I think we don't have the same reason.

Also, whatever is happening in Korea doesn't matter — we're talking about Japan.

It will be available to foreigners some where in Asia before 2027, provided that the phase II trials produce favorable results, but I don't know if foreigners are excluded from the conditional approval in Japan. This is pretty simple logic. Do you follow?

No, it will be available in Asia sometime within the next few years.

The time before it is granted full market approval could be anywhere from months, to the full allocation. I used 2027 as an example of the timeframe allowed if it were launched in 2020.

Please provide a reference for this objective, government-enforced answer as to whether or not foreigners will be allowed to participate in conditional market approval for RCH-01 in Japan.


Normally I agree with most of your posts That Guy but this was just sloppy and half assed.

Only two possibilities exist:

• Foreigners are allowed to participate in the conditional approval stage, with or without specific conditions.

• Foreigners are not allowed to participate in the conditional approval full stop.

Somewhere, in a language I can't understand, this rule IS stated. I guarantee you that.

 

[00000]

How in the hell are all of you gunna just float past my post and not even acknowldge me! What the...!!! You better copy paste this post because I am honestly telling you all the truth. I will be a legend on this board once you see how right I am

Me: BTW I was sent back from the future to tell all of you that RCH-01 will be available in the United States before you are ready for it, and before Japan completes Phase 3...

You: Whaaa>>> how is this possible!! Nonesense!

Me: Lol. Okayyy

You: But what do you mean?? How can this be... What about FDA blah blah blah....

Me:

You: TELL US GAWD DAMMIT!!!!!!!! NOW!!!!!

Me:

You: YOURE FULL OF sh*t AND NO NOTHING!!!! LIAR!!!! STOP LYING!!!!

Me: If you say so bud

 

[TK421]

How in the hell are all of you gunna just float past my post and not even acknowldge me! What the...!!! You better copy paste this post because I am honestly telling you all the truth. I will be a legend on this board once you see how right I am

I'm all ears, tell me why you think it will be available in the U.S. sooner than we think it is.

 

[Super Metroid]

Ps. One patient had a 20.4% increase over Baseline Bitchez

I always wonder what the exact definition of such increases actually is. Does it refer to a specified area on the head or on the whole head. Anybody that knows?

 

[Bigoldben]

The thing is there’s a significant number of people in Japan who know all the answers to this, potentially a number of people who were losing hair and now aren’t. That’s something worth holding onto. Companies tend to be quite tight lipped while trials are going on but I imagine they’ve had some success over the last couple of years otherwise the trial would have been pulled and the whole thing swept under the carpet.

 

[kevin west]

Japanese companies have never said what time to release. Our current timetables are Canadian hype, and a blog news. Please stop guessing. This will make you desperate.

 

[kawnshawn]

If it works, how would the all powerless FDA stop them from selling it in a country known for having had bogus stem cell therapies and catch me if you can witch doctors scamming the public? If it works at all, the FDA aint gonna stop it. If it works, then people will buy it with or without approval.

lol what kind of crack are you smoking? This is one of the lowest iq post I've read on this forum.

 

[RegenWaiting]

There is no rush to bring it to other parts of Asia. Nothing indicates that right now.



I don't know when it will be available to the rest of the world. So I think we don't have the same reason.

Also, whatever is happening in Korea doesn't matter — we're talking about Japan.



No, it will be available in Asia sometime within the next few years.

The time before it is granted full market approval could be anywhere from months, to the full allocation. I used 2027 as an example of the timeframe allowed if it were launched in 2020.



Only two possibilities exist:

• Foreigners are allowed to participate in the conditional approval stage, with or without specific conditions.

• Foreigners are not allowed to participate in the conditional approval full stop.

Somewhere, in a language I can't understand, this rule IS stated. I guarantee you that.

Hello there,

Regarding Japan's Laws about conditional market approval for regenerative medicine as of late 2014,
I think this may be a good and interesting read to shed some light on what could, realistically, be expected.

https://www.sciencedirect.com/science/article/pii/S1934590915001241

Particularly one paragraph is of special interest:

The difficulties in testing products in randomized clinical trials on a post-market basis are well known. Few subjects will choose to enter a trial if they already have access to the agent, and there is a significant risk of biasing inclusion/exclusion and outcome evaluation if access is influenced by ability to pay (the high estimated prices for regenerative medicine products may put them out of reach of low-income subjects, even with insurance), or the act of paying itself. Whether evaluation of efficacy for conditionally approved products under the new Japanese system will be through consultation with relevant medical specialties, centralized outcome reporting, or some other measure has not been made public, but it will be an enormous challenge to identify an approach that is as reliable and free of subjective bias as the randomized clinical trial. The lack of an explicit plan for determining efficacy during the conditional approval period points to a strong underlying assumption that regenerative medicine products will ultimately prove efficacious.

I do not think this is conclusive in that we'll indeed have the choice whether to participate or not, if...or
when RCH-01 is granted a conditional market approval. However, it does to some extent allude to that
the companies are not on a ''short leash'' when designing and executing the ''post-market''
clinical trial aka commercialization on certain terms.

Cheers

 

[Bigoldben]

I think the options available to us now are either becoming experts in Japanese and then Japanese law OR (unfortunately) waiting for August/ September when the trial results emerge and the market release (hopefully) information is released.

I suppose then there’s two options if the trials are successful:
A. Travel to Japan (if it’s allowed) and have the treatment there
B. Wait for Replicel to complete their trials which we’ll already know the answers too OR hope authorities over here take the Japanese results

In the meantime let’s all hope and pray that this is a roaring success. The dream is for in 30+ years time for my son to approach me with my thick black hair and tell me he thinks he’s going bald at which point I’ll tell him my secret.

 

[kingjohn]

@kingjohn mentioned in a Tsuji thread that a arthiritis treatment was available in Korea right after Phase 2. How does that work?
Is @kingjohn atill here?

it was an alzheimers therapy not an arthritis therapy and it was in japan not korea

https://www.businesswire.com/news/h...ure-Cell-Biostar-Stem-Cell-Research-Institute

 

[Javell]

it was an alzheimers therapy not an arthritis therapy and it was in japan not korea

https://www.businesswire.com/news/h...ure-Cell-Biostar-Stem-Cell-Research-Institute

Residents of Japan who are suffering from Alzheimer’s can receive treatment by directly contacting Trinity Clinic Fukuoka. Residents in South Korea, the United States and other countries can inquire with Biostar Korea for a treatment reservation.

With the start of stem cell treatment, Biostar will support Alzheimer’s patients from all over the world.

I spread false info about Korea, I misread some sentences. But this seems good news for us as it seems that it is avaible for people all over the world in Japan under Japanese laws. So, those check-ups may not be mandatory or could be done remotely.

Shiseido could do the same since the stem cell law under which that Alzheimer's theraphy was developed is the same.

 

[Bigoldben]

The report doesn’t make a western release sound too imminent. That said they are probably as reliant on the Japanese results as we all are. I suspect that it will be years before we see it in the west. Fingers crossed shiseido get it effective and available too all way before that.

 

[kawnshawn]

UPDATE WITH SOURCE: https://www.streetinsider.com/dr/news.php?id=14181663

Aight, I did a quick glance over. in regards to Shesido.

"Collaboration Agreement

We have entered into a Collaboration and Technology Transfer Agreement with Shiseido, one of the world’s largest cosmetic companies. Both companies will work towards establishing a clinical research program in Asia, with the goal of increasing the available human clinical data on RCH-01. We anticipate that collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party. This agreement gives Shiseido an exclusive geographic license to use our RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people. In mid-2016, Shiseido alleged that our company breached the agreement which resulted in a termination of the agreement. We have vigorously denied the existence of any breach of the agreement and believe that the agreement is still in good standing. No litigation, arbitration or other dispute mechanisms has been triggered by either party and our management is actively seeking to continue discussions and/or negotiations with Shiseido to resolve the matter. In mid-2016, Shiseido announced the commencement of a hospital-sponsored clinical study of RCH-01 in Japan funded by Shiseido. The clinical data produced in such a trial would, by agreement, be made available to our company"

So they are still partnered together. Still no word on a potential 2018 or even 2019 release date like Replicel was claiming a few years back when the trial began. Shesido hasn't taken any legal action and the claim they made was back in 2016. There is definitely some negative stuff behind the scenes with these two cpmpanies still.

 

[Bigoldben]

Aight, I did a quick glance over. in regards to Shesido.

"Collaboration Agreement

We have entered into a Collaboration and Technology Transfer Agreement with Shiseido, one of the world’s largest cosmetic companies. Both companies will work towards establishing a clinical research program in Asia, with the goal of increasing the available human clinical data on RCH-01. We anticipate that collaborative technology transfer will continue between the companies as any new improvements to the RCH-01 technology are developed by either party. This agreement gives Shiseido an exclusive geographic license to use our RCH-01 hair regeneration technology in Japan, China, South Korea, Taiwan and the ASEAN countries representing a population of approximately 2.1 billion people. In mid-2016, Shiseido alleged that our company breached the agreement which resulted in a termination of the agreement. We have vigorously denied the existence of any breach of the agreement and believe that the agreement is still in good standing. No litigation, arbitration or other dispute mechanisms has been triggered by either party and our management is actively seeking to continue discussions and/or negotiations with Shiseido to resolve the matter. In mid-2016, Shiseido announced the commencement of a hospital-sponsored clinical study of RCH-01 in Japan funded by Shiseido. The clinical data produced in such a trial would, by agreement, be made available to our company"

So they are still partnered together. Still no word on a potential 2018 or even 2019 release date like Replicel was claiming a few years back when the trial began. Shesido hasn't taken any legal action and the claim they made was back in 2016. There is definitely some negative stuff behind the scenes with these two cpmpanies still.

Yeah although it wouldn’t be beyond the realms of possibility that this was Shiseido flexing its muscles as the larger company.

 

[That Guy]

Still no word on a potential 2018 or even 2019 release date like Replicel was claiming a few years back when the trial began.

RepliCel never claimed there'd be a release then, either.

They said that given Japan's laws, and with the phase II concluding this year, 2018/2019 was the earliest possible timeframe that it could be released.

But it entirely depends on what Shiseido plans to do.