Replicel Is On Fire Lately — Data In Feb.

[MeDK]

I mean what about rch-01? they said they'd launch the damn thing in late 2018, then they said in july we would see trial results but NOTHING happened. so this research is very unimpressive actually if they still don't have a product after more than a literal decade

Like i already have linked to replicel twitter answer, the july release of data, looks like internal data release than public release. Then its replicel or who ever that controls their public data release to decide when it goes public.

But new technology takes time, that's how it is within all fields of science, you can set a deadline, but its not always its met if they got need problems they didn't foresee.

It takes time, and they still do research like their latest paper showing that they still learn new stuff about hair.

just think about that first extract of DNA was in 1869, and was first defined as DNA in 1929, discoveries takes time. It takes time to even know they done a new discovery and what it is. just like with DNA.

 

[JFLAtMtBalding]

just think about that first extract of DNA was in 1869, and was first defined as DNA in 1929, discoveries takes time. It takes time to even know they done a new discovery and what it is. just like with DNA.

Sadly we don't have time

 

[Armando Jose]

Optimism is associated with exceptional longevity in 2 epidemiologic cohorts of men and women
https://www.pnas.org/content/early/2019/08/20/1900712116

Time to change chip

 

[vvvazvvv]

https://theocmx.com/marketplace/replicel/

Pipeline of new investors replicel.

They suggest data of shiseido in Q3/4 this year. They seem possitive about rch-01

 

[Undertaker]

https://theocmx.com/marketplace/replicel/

Pipeline of new investors replicel.

They suggest data of shiseido in Q3/4 this year. They seem possitive about rch-01

When it comes to investors, they are always optimistic

 

[MeDK]

A market launch from Replicel next year, their RCI-02, they are suggesting a launch in 2020 for several markets next year.

As it have been said before, the RCI-02 is a part of their total product strategy with the RCH-01, so at least something is happening with a real product launch from Replicel.

 

[MeDK]

they do not have a strategy. this is completely out of their hands at this point. the last article they published on rch-01 is from last year lol. replicel is almost as organized as my life

Replicel have always said they want the RCI-02 developed along side with RCH-01 at phase 2, because they want to make the RCI-02 a combined package with RCH-01. So now it can also be used for phase 3 clinical trails with their RCI-02 to get more uniform injections and so on.

That is how i remember it from their other press releases. about the whole RCI-02 and RCH-01 development pipeline.

 

[ZP31]

Replicel have always said they want the RCI-02 developed along side with RCH-01 at phase 2, because they want to make the RCI-02 a combined package with RCH-01. So now it can also be used for phase 3 clinical trails with their RCI-02 to get more uniform injections and so on.

That is how i remember it from their other press releases. about the whole RCI-02 and RCH-01 development pipeline.

They released the rights of RCH to Shiseido. They have no control over it right now.

 

[MeDK]

They released the rights of RCH to Shiseido. They have no control over it right now.

its simply not true.

"RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries."

 

[ZP31]

its simply not true.

"RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries."

Why do you think then that Replicel has not released the phase 2 results? They are at the mercy of Shiseido who has not told them anything.

 

[MeDK]

Why do you think then that Replicel has not released the phase 2 results? They are at the mercy of Shiseido who has not told them anything.

Because data takes time to process? And maybe there are more coordination than we are aware of is they want to proceed beyond Phase 2, there can many options why data isn't made public as soon as internal data. Just remember that internal data was released last month, so I can't see how they are in the mercy of anyone.

And if Shiseido owned the rights, then why do replicel also have a phase 1 in Europe for RCH-01?

 

[Throwaway94]

Because data takes time to process? And maybe there are more coordination than we are aware of is they want to proceed beyond Phase 2, there can many options why data isn't made public as soon as internal data. Just remember that internal data was released last month, so I can't see how they are in the mercy of anyone.

And if Shiseido owned the rights, then why do replicel also have a phase 1 in Europe for RCH-01?

Because they were hoping that money would roll in from Shiseido commercialising in Japan, allowing them to fund and commercialise themselves for the European market?

 

[MeDK]

Because they were hoping that money would roll in from Shiseido commercialising in Japan, allowing them to fund and commercialise themselves for the European market?

of course when you license something out, you want to make a profit. and Shiseido is funding that for the asian market.

But if you look into their phase 2 in Europe, they are quite transparent about what needs to be done before they start on it.

"A phase 2 trial to study dosing & treatment frequency will be conducted once data is obtained from a molecular marker research study and the RCI-02 injector is available for clinical use."

And now that we know that they release RCI-02 injector into the EU market next year, then they are one step closer to a phase 2 trail in Europe. The research study i don't know if they have gotten that yet.

 

[Throwaway94]

of course when you license something out, you want to make a profit. and Shiseido is funding that for the asian market.

But if you look into their phase 2 in Europe, they are quite transparent about what needs to be done before they start on it.

"A phase 2 trial to study dosing & treatment frequency will be conducted once data is obtained from a molecular marker research study and the RCI-02 injector is available for clinical use."

And now that we know that they release RCI-02 injector into the EU market next year, then they are one step closer to a phase 2 trail in Europe. The research study i don't know if they have gotten that yet.

Royalties from Shiseido would have been a much better bet for steady income to fund the trial than their dermal injector, and they could be considered at Shiseido's mercy because that money won't come their way if Shiseido decides not to commercialise and not share their phase 2 results, or to withhold royalties due to the contract breach.

 

[MeDK]

Royalties from Shiseido would have been a much better bet for steady income to fund the trial than their dermal injector, and they could be considered at Shiseido's mercy because that money won't come their way if Shiseido decides not to commercialise and not share their phase 2 results, or to withhold royalties due to the contract breach.

Where do you guys get all of this from?

Any reliable sources? Or are we just tin foil speculating ?

 

[Throwaway94]

Where do you guys get all of this from?

Any reliable sources? Or are we just tin foil speculating ?

“Because of financial constraints, RepliCel has not been able to proceed with its previously announced plans to initiate a phase 2 clinical trial of RCH-01,” stated RepliCel’s Buckler. “This has caused Shiseido to allege breach of our co-development obligations which we deny and vigorously oppose. While there is a clear obligation on our part to transfer data from such a trial when it is available, there is no express or implied obligations in the agreement as to when such a trial would have to be initiated or completed,” continued Buckler.

RepliCel owns unfettered market and development rights to RCH-01 outside of Shiseido’s territory in Asia. In the Agreement there are milestone payments and sales royalties flowing from eventual commercialization of the product in Shiseido’s territory. “In a worst case scenario wherein Shiseido is able to show breach of contract by RepliCel, we may lose some or all rights to milestone and royalty payments from Shiseido but still be in a position to capitalize on the product’s enormous potential everywhere else in the world. In the meantime, we remain steadfast to our position that the mutual obligations in the agreement remain intact,” Buckler concluded


They remain optimistic about being able to capitalise elsewhere in the world, but with no money from Shiseido, realistically they would need the dermal injector to perform very well in the market first or to find another licensee.

 

[MeDK]

“Because of financial constraints, RepliCel has not been able to proceed with its previously announced plans to initiate a phase 2 clinical trial of RCH-01,” stated RepliCel’s Buckler. “This has caused Shiseido to allege breach of our co-development obligations which we deny and vigorously oppose. While there is a clear obligation on our part to transfer data from such a trial when it is available, there is no express or implied obligations in the agreement as to when such a trial would have to be initiated or completed,” continued Buckler.

RepliCel owns unfettered market and development rights to RCH-01 outside of Shiseido’s territory in Asia. In the Agreement there are milestone payments and sales royalties flowing from eventual commercialization of the product in Shiseido’s territory. “In a worst case scenario wherein Shiseido is able to show breach of contract by RepliCel, we may lose some or all rights to milestone and royalty payments from Shiseido but still be in a position to capitalize on the product’s enormous potential everywhere else in the world. In the meantime, we remain steadfast to our position that the mutual obligations in the agreement remain intact,” Buckler concluded


They remain optimistic about being able to capitalise elsewhere in the world, but with no money from Shiseido, realistically they would need the dermal injector to perform very well in the market first or to find another licensee.

And somewhat a year later they wrote

"In Japan, we are pleased Shiseido continues to fund the two-site clinical research study for pattern baldness (RCH-01). While our relationship continues to be troubled to the point of alleged breach and termination, there has been no litigation, arbitration or other dispute resolution triggered. We continue to maintain our position that the agreement and relationship remains in good standing. Recent correspondence suggests the possibility of resuming discussions between the parties under certain conditions. We look forward to data from the Japanese RCH-01 (pattern baldness) study anticipated sometime in 2018 and continue to develop our own plans around the asset for markets outside Asia."

And there haven't really since been any talk about their relationship, and in march/may when ever it was, replicel also wrote that they would receive data from phase two last month.

So to me, there are no signs of "being in the mercy of Shiseido"

 

[Throwaway94]

And somewhat a year later they wrote

"In Japan, we are pleased Shiseido continues to fund the two-site clinical research study for pattern baldness (RCH-01). While our relationship continues to be troubled to the point of alleged breach and termination, there has been no litigation, arbitration or other dispute resolution triggered. We continue to maintain our position that the agreement and relationship remains in good standing. Recent correspondence suggests the possibility of resuming discussions between the parties under certain conditions. We look forward to data from the Japanese RCH-01 (pattern baldness) study anticipated sometime in 2018 and continue to develop our own plans around the asset for markets outside Asia."

And there haven't really since been any talk about their relationship, and in march/may when ever it was, replicel also wrote that they would receive data from phase two last month.

So to me, there are no signs of "being in the mercy of Shiseido"

Literally nothing new was revealed in that update, Shiseido were conducting their own trial as per normal but with no guarantee they'd share those results as the contract breach issue is still not resolved despite their vague "possibly resuming discussions between the parties under certain conditions" - no news is not good news. Replicel only speculated that Shiseido would release their data publicly just like everyone else did, until the contract breach is actually resolved Replicel aren't privy to Shiseido's findings.

 

[MeDK]

Literally nothing new was revealed in that update, Shiseido were conducting their own trial as per normal but with no guarantee they'd share those results as the contract breach issue is still not resolved despite their vague "possibly resuming discussions between the parties under certain conditions" - no news is not good news. Replicel only speculated that Shiseido would release their data publicly just like everyone else did, until the contract breach is actually resolved Replicel aren't privy to Shiseido's findings.

We can speculate on this for a very long time, but reality is, none of us have access to their contract and other deals they have between each other.

All we know is, that it was expected that shiseido would have some data in july. but shiseido haven't been clear about public data release. So that what we know from official channels like replicel themself.

And we know that replicel won't start a phase 2 for RCH-01 before the RCI-02 is commercially launched and before shiseido have told what they want to do after the data release.

And we know that the market release for RCI-02 is 2nd half of 2020, so that gives them a timeline in about 10 months to even start their own phase 2 in RCH-02 in Europe. So for know there isn't really a rush, they only rush would be the japanese market release if they chose to do so.

 

[ZP31]

We can speculate on this for a very long time, but reality is, none of us have access to their contract and other deals they have between each other.

All we know is, that it was expected that shiseido would have some data in july. but shiseido haven't been clear about public data release. So that what we know from official channels like replicel themself.

And we know that replicel won't start a phase 2 for RCH-01 before the RCI-02 is commercially launched and before shiseido have told what they want to do after the data release.

And we know that the market release for RCI-02 is 2nd half of 2020, so that gives them a timeline in about 10 months to even start their own phase 2 in RCH-02 in Europe. So for know there isn't really a rush, they only rush would be the japanese market release if they chose to do so.

It’s pretty safe to assume that Replicel is in dire need of some capital - take a look at their share price over the last few years. If they had results of Shiseido’s RCH phase 2 trial, they would have released them by now. The only time their share price has jumped exponentially has been when good news regarding RCH 01 has surfaced.

This leads me to believe that Replicel do not possess the Phase 2 results and that they are in conflict with Shiseido over them.