Replicel Is On Fire Lately — Data In Feb.

[itsjustsimon]

Will Shiseido/ Replicel be effective for diffuse thinning? In other words do you need good donor hair somewhere on the head for this treatment?

As I understand Replicel, it's made for diffusers. I don't believe it will grow on slick bald areas especially after latest efficiency results. It's more a maintenance with a little regrowth and increased thickness.

 

[That Guy]

As I understand Replicel, it's made for diffusers. I don't believe it will grow on slick bald areas especially after latest efficiency results. It's more a maintenance with a little regrowth and increased thickness.

I don't think they've ever suggested it is tailor-made for diffuse thinners

but obviously, it would benefit them quite a bit.

 

[Taep]

Do you think the replicel will be released? When are you expecting it?

 

[razzmatazz91]

When RepliCel Phase II is over in Q2 then we will get an Update in June. Am I correct?

No. In July to September. That Q2 FY 2018-19.

 

[Taep]

No. In July to September. That Q2 FY 2018-19.

what is mean "That Q2 FY 2018-19."
is it 2018 or 2019 Q2?

 

[Bigoldben]

Financial quarters are January, February, March then April, May, June then July, August, September and then October, November and December.
I’m not sure if it’s different in Japan though or whether the trial will be finished then and the data released later. At that point they will announce their market intentions (or a nightmarish lack of).

Does anyone know what the consequences of the American drug laws released are? From my, extremely limited, understanding they effectively mean that in America laws are similar to Japan. Also does every drug have to undergo trials in every country?

 

[dermrafok]

No. In July to September. That Q2 FY 2018-19.

Q2-2018.

Forget 2019

 

[Bigoldben]

Q2-2018.

Forget 2019

So does that mean results will be by end of June in theory or end of September in your opinion?

 

[Cloudburst]

The Japanese financial year runs 1 April - 31 March so if results come in Q2, expect then between July-September.

 

[Bigoldben]

The Japanese financial year runs 1 April - 31 March so if results come in Q2, expect then between July-September.

Yeah I suppose so although it is replicel who have announced q2 to their shareholders so I think end of June is a possibility. It’s a four month window though which is not a huge amount of time in the grand scheme of things.

 

[br1]

Will Shiseido/ Replicel be effective for diffuse thinning? In other words do you need good donor hair somewhere on the head for this treatment?

I believe it will be specially good for diffuse thinners.. Given that the treatment works..

 

[Javell]

On the one hand, it is funny than this thread is becoming like Brotzu's, just another place to went pent up emotions and hope to the end of hopelesness while to consistenly going off-topic.
On the other hand, what the hype in this case is far more justifiable.

 

[itsjustsimon]

Ok Why do You think is Replicel so calm? In The last Interview in a Radio Station Replicel didnt say Anything about RCH-01. do You mean that could be a sign that The Phase II Trials were Really Bad?

Because Shiseido is doing the trials and right now Replicel is just waiting for results.

Edit: I was listening to that interview and I notice interviewer had no specific question or interest toward their hairloss cure.

 

[itsjustsimon]

You Are Right The Interview was such an idiot. But The Replicel guy could make Marketing for The RCH-01 and Tell something about this. This Males me nervous because The Signs out of The Phase II should be known.

I don’t know man... If I would be a CEO (or the guy on the radio show), I would try to market other technologies because RCH-01 is already “sold” to Shiseido. But who f*****g knows what’s going on TBH

 

[kawnshawn]

Ok Why do You think is Replicel so calm? In The last Interview in a Radio Station Replicel didnt say Anything about RCH-01. do You mean that could be a sign that The Phase II Trials were Really Bad?

Apparently Replicel fucked up their relationship with Shesido because they weren't able to give Shesido the cell culture they used (something along those lines) and didn't initiate their own phase two trial earlier because of monetary constraints. All we know is that Shesido has claimed that Replicel has breached their contract because of that.

We don't know where they still stand as a partnership. Even at the Hair Congress when Hellouser talked to a Shesido rep about Replicel he was very dismissive about the partnership. My big worry is that if their relationship is fucked because of that then how will it affect their decision to bring it to market.

But ya, If I were Lee and went on a radio program to discuss my company and products I would definitely mention the one that is a cell therapy that is closest to being released. Like how do you not mention something important like that unless their are issues behind the scene

 

[hanginginthewire]

As far as the results of phase 2 the Replicel dude has definitely recently referred to the release of the results this year. It was listed in a “what to expect in 2018” message. So Replicel is still “marketing” it as far as that goes.

 

[Cloudburst]

I think the dispute stretched the relationship but it looks to still be on course; no separation of the partnership was announced and as they’re listed companies they would need to report that. This is a product I think will be available to some extent within twelve months; my only concern is to who. Not trying to be pessimistic - as a diffuser on a path beyond the reaches of a transplant my eggs are solely in this basket as I think hair cloning is a way away - but global reach for a hair loss vaccine (apparently) just seems a bit of a stretch.

 

[That Guy]

I think the dispute stretched the relationship but it looks to still be on course; no separation of the partnership was announced and as they’re listed companies they would need to report that. This is a product I think will be available to some extent within twelve months; my only concern is to who. Not trying to be pessimistic - as a diffuser on a path beyond the reaches of a transplant my eggs are solely in this basket as I think hair cloning is a way away - but global reach for a hair loss vaccine (apparently) just seems a bit of a stretch.

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.

 

[Cloudburst]

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.

 

[hanginginthewire]

I think the dispute stretched the relationship but it looks to still be on course; no separation of the partnership was announced and as they’re listed companies they would need to report that. This is a product I think will be available to some extent within twelve months; my only concern is to who. Not trying to be pessimistic - as a diffuser on a path beyond the reaches of a transplant my eggs are solely in this basket as I think hair cloning is a way away - but global reach for a hair loss vaccine (apparently) just seems a bit of a stretch.

Don’t worry, there’s Follica too....

Lol just kidding diffusers are screwed.