Replicel Is On Fire Lately — Data In Feb.

[Keisi92]

You're naive if you think that there will be no bald people if there is a permanent maintenance treatment. There will still be those who will realize that they are balding when its too late, or those who will realize that hair matters.

One successful product doesn't stop innovation. Same with Tsuji, Tsuji may and will get competition sooner or later. Competition is good, alternatives mean cheaper costs.

Have you forgotten cancer patients, they can lose hair in chemo and never recover it.

I Think most people realize they are losing hair when they are at a nw2 from personal experience, talking about myself and other friends who have hairloss. Which tbh is a pretty acceptable hariline if you maintain at. I am not saying that there won't be competition and research, but it will be towards similar treatments with similar outcomes imho. Targeted more at preventing than reversing.

While cancer patients would be a good market, even with the current rates of people getting cancer and going through chemo I find it a small market and not worth it to invest a lot of resources on a condition which has proved to be not so easy to treat. This is always a personal opinion obviously.

 

[BaldyBalderBald]

So, what does it change?
Speculation, speculation.

It changes things for cancer patients, not for us
You mention cancer as it was relevant, it's not.The only two people i know who undergo chemo therapies regrow their full head afterward without any treatments, so stop making speculation too

 

[itsAlright]

https://www.nytimes.com/2017/11/16/health/fda-gene-cell-therapy.html

"Gene and cell therapies that demonstrate the potential to treat unmet medical needs and serious illnesses may now qualify for expedited review to get the products to market more quickly, the guidelines say. The F.D.A. will still require clinical trials, but it is promising a faster process, as required by Congress under the 2016 21st Century Cures Act."

"The agency’s announcements included two final guidelines and two drafts that will be open for public comment. They are designed to help developers sort out whether they need to submit a licensing application to the F.D.A. to get approval for their treatments or fall into a lower risk category, which does not need premarket approval."

I really hope Lee Buckler is doing his homework, it seems to me like Replicel would fall into the category of being a cell based treatment that is both low risk and addressing an unmet need. It is articles like this that make me wish Shiseido had control of the US market as well, I would expect they have much greater shot at convincing the FDA to allow them an expedited approval process.

Also, I'm still hopeful that the SkinTE product we heard about recently will be a potential dark horse candidate to skirt FDA approval with a hair loss treatment, much like they did recently with their wound treatment.

 

[clarence]

https://www.nytimes.com/2017/11/16/health/fda-gene-cell-therapy.html

"Gene and cell therapies that demonstrate the potential to treat unmet medical needs and serious illnesses may now qualify for expedited review to get the products to market more quickly, the guidelines say. The F.D.A. will still require clinical trials, but it is promising a faster process, as required by Congress under the 2016 21st Century Cures Act."

Some people think the FDA should be much, much slower:

"Trump's attacks (agains't the alleged FDA slugginess) have infuriated former and current agency officials who say they are unfair and misguided. They point out that reviews for new prescription drugs have sharply accelerated in recent decades. Today, the FDA routinely beats other regulators around the world and sometimes even gets heat for moving too quickly to green-light products."

David A. Kessler perhaps would agree;

“The competitiveness of the U.S. pharmaceutical industry is based on the fact that the drug is validated as safe and effective by the FDA,” said David Kessler, who was the agency's commissioner chief during the administrations of George H.W. Bush and Bill Clinton. “Any proposal that doesn't require both will set back the industry's competitiveness by 50 years.”

 

[Trichosan]

"...The competitiveness of the U.S. pharmaceutical industry is based on the fact that the drug is validated as safe and effective by the FDA,” said David Kessler..."

That's how you know it's bullshit. Competition provides the best service to society because it is based on quality of service, price and innovation which stems from free enterprise. Not some bureaucratic Good Houskeeping seal of approval.

 

[BaldyBalderBald]

Well a drug validated as safe and effective is a part of the 'quality of service' no ?

 

[RichieRich]

Even for NW4+ a good hair transplant can bring solace.

Playing devils advocate here but but i wonder how well a hair transplant would react with this immunization process what with shock loss and what not

 

[Theprofessional]

Thanks

 

[br1]

Replicel has tweeted this ( I don't think I have seen it floating around this thread yet)

https://investingnews.com/daily/lif...pproval-dermal-injector-impact-europe-beyond/


They sound very excited about Shiseido too, if one would be "Brotzu-thread like excited", would think they know it works. But, we are rational around here, so let's wait. Data is coming early next year.

 

[br1]

RepliCel’s stem cell candidates could enter Japanese market

The company’s stem cell research has led to a promising licensing deal in Japan with Shiseido (TYO:4911). This company can activate a rush of revenue for RepliCel if it brings RCH-01 to the market. This is one of their candidates designed to treat androgenetic alopecia (hair loss). RepliCel also has candidates for tendon repair and a skin rejuvenation treatment.

Colin Lee Novick, managing director of CJ PARTNERS explained in Japan the Pharmaceuticals and Medical Devices Agency (PMDA) approved products under the Japanese PMD Act, this means the product gets to be covered by the national health insurance system.

“Of the three products that RepliCel has—for tendons, skin and the hair androgenic alopecia product—one is a shoe-in for the PMD Act, the tendon product. The other two would allow it to release under something called the Act on the Safety of Regenerative Medicine (ASRM), which is a new law passed in tandem with the revision of the PMD Act in 2013-2014,” Novick told Streetwise Reports.

Below is a transcript of our interview, which has been edited for clarity and brevity. Read on to find out more of what Buckler had to say.

 

[ZenHead]

Well this is definitely good news. I thought replicel and Shiseido were in some sort of contract fued but now it looks like things have cleared up? I had my doubts but a late 2018 release seems possible like they originally indicated

 

[MrV88]

Still wondering if Shiseido can regrow some of our hair or if it's just for immunizing the "old" ones.

Another question would be if they can thicken existing fuzzy and nearly diminished follicles back to their original size.

 

[BaldyBalderBald]

Still wondering if Shiseido can regrow some of our hair or if it's just for immunizing the "old" ones.

Another question would be if they can thicken existing fuzzy and nearly diminished follicles back to their original size.

Result from phase 1

"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."

https://replicel.com/20170314-2/

 

[ElTioLaBota]

If you have retrogade it menas that replicel or tsuji isn't gonna do sh*t for my hair?

 

[MrV88]

Result from phase 1

"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."

https://replicel.com/20170314-2/

Aaaand this is for just one injection without the specific amount and quantity of the drug that could lead to better results, right? So it "can" even be better than this.

 

[BaldyBalderBald]

If you have retrogade it menas that replicel or tsuji isn't gonna do sh*t for my hair?

I don't think so brah, that's just a theory, but with retrograde there's still some follicles not attacked by DHT, so they can still make a biopsy to check healthy follicles and culture those extracted cells
DUPA are more likely to be fucked unfortunately IMO, but retrogrades should be fine

Again that's a just a theory...Aaaannndd CUT

 

[BaldyBalderBald]

Aaaand this is for just one injection without the specific amount and quantity of the drug that could lead to better results, right? So it "can" even be better than this.

Yeah, in Phase 2 they are gonna test repeated injections with different quantities, safer to wait for results before speculate for greater results, but it "can"

 

[ZenHead]

Phase 1 was just one injection. Imagine the result from multiple repeating injections. The results from phase 2 will be much, much better in my opinion, but we’ll see. I have a feeling most weaker / vellus hairs will turn terminal.

 

[BaldyBalderBald]

Phase 1 was just one injection. Imagine the result from multiple repeating injections. The results from phase 2 will be much, much better in my opinion, but we’ll see. I have a feeling most weaker / vellus hairs will turn terminal.

Man, this is speculation, we can't know that for now, Samumed results were weaker when they increased doses and repeating injections didn't do sh*t neither, stay optimistic, but careful

 

[tomcat]

wow 19 % increase better start saving