New Puretech Website Layout (pivotal Trial First Half Of 2018)

[SamFT]

I know that. What I wrote was an affirmation.

How long, though, was the question.

Honestly that is something we will find out when they trials is in process.
Phase ll on average last anywhere from 6-12 months.
Phase lll can last anywhere from 1-3 years. But considering they are getting a different approval and there are so many different policies and rules for what kind of treatment you are creating and what for its hard to say. Possibly they could only need 6 months for them to get the data they need but its all confusing and not anyone here will have the exact answer. So again it's just a wait and see game again

 

[champpy]

Neogenesis sounds great, until you realize that these new follicles are trying to make a home in an area of your head that doesnt want them there.
Something else (hopefully a new compound) is going to have to be applied or taken to keep these new hairs healthy and alive and well.

 

[CopeForLife]

loafers

 

[kiwipilu]

Keep dermrollin' rollin' rollin' rollin' (what?)
Keep dermrollin' rollin' rollin' rollin' (come on)
Keep dermrollin' rollin' rollin' rollin' (yeah)
Keep dermrollin' rollin' rollin' rollin'
Now I know why'all be lovin' this sh*t right here

 

[Bad_Wolve]

some words to my american friends.

years of frustration are behind us. lost years. many of us have no self confidence left. other ones are crying like babies at home, because their nw0 friends are getting the girls by going out. i can´t imagine how much pain baldies felt in the past.

now there is something that works and approved by a reputable scientiest. what are we doing? nothing except crying on this forum.

there is just on life and we need to take it in our hands.

we are such a strong communitiy, please my american friends, drive to cots, or the fda and then camp outside of their institutions as long as the media is there. then they will listen to us and things will go faster. also with donald trump there is a big chance to avoid stupid regulations when a treatment is already proven to be safe. please get out, i am begging to you, i would do the same in my country if there would be a potential treatment, i dont want to live longer with this disease. lets change our future in common!!!!!!!!!!

 

[br1]

Honestly that is something we will find out when they trials is in process.
Phase ll on average last anywhere from 6-12 months.
Phase lll can last anywhere from 1-3 years. But considering they are getting a different approval and there are so many different policies and rules for what kind of treatment you are creating and what for its hard to say. Possibly they could only need 6 months for them to get the data they need but its all confusing and not anyone here will have the exact answer. So again it's just a wait and see game again

"Pivotal Phase 2" and "Phase 3" are the same thing.

 

[Noisette]

Hmmm. I typically only understand clinical pipelines in terms of Phase I, II, and III. Safety, efficacy and whatever.
What are "pivotal" and "optimization" trial and how long do they usually last?

Hi @Breyfogle
Pivotal trials are studies in Phase 3. The pre-pivotal pilot optimization study is a study to improve Phase 3 trials.

The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years.

And, initialy, Puretech health expected to have a clearance from FDA in the last of 2017.
So we can thinking that they will expect a clearance in the end of 2018.

 

[Pavi]

This is significant news. I don't care how anyone slices it. We could have this out by January 2019. That's literally only 14 months away. Yes, 14 months can cause hair loss but in the grand scheme of things it's rather short. I joined here 2 years ago and boy had time flown

 

[hanginginthewire]

This is significant news. I don't care how anyone slices it. We could have this out by January 2019. That's literally only 14 months away. Yes, 14 months can cause hair loss but in the grand scheme of things it's rather short. I joined here 2 years ago and boy had time flown

We don't know what the treatment really consists of though...

 

[H]

Thing is, why are they using the term 'neogenesis' when it implies NEW follicle creation? If that's the case, it shouldn't matter if it's vertex, crown, temples, diffuse, etc.

I'm not saying it won't work in some way for people besides slightly diffuse I'm saying it's not going to take your barren temples or slick bald vertex and restore them to anything admirable. If someone just wants a few more hairs but doesn't care about still looking diffuse just a little less so sure they could use it too I just couldn't justify paying for a few more hairs myself. The thing that irritates me about this whole wounding deal is say I do it to my arm what then? It turns into more arm hair? My chest? My face? Can I make more beard hairs which are 3 times as thick as scalp hair? Does the area of skin I wound differentiate what hair is actual going to be produced do these guys even know really why it works? So many questions. To me personally I could be wrong but from my point of view Cots couldn't come up with anything amazing to cure hair loss so he basically took an idea people were already using made a fancy looking dermaroller that they could say was next gen and are commercializing it.

 

[hellouser]

I'm not saying it won't work in some way for people besides slightly diffuse I'm saying it's not going to take your barren temples or slick bald vertex and restore them to anything admirable. If someone just wants a few more hairs but doesn't care about still looking diffuse just a little less so sure they could use it too I just couldn't justify paying for a few more hairs myself. The thing that irritates me about this whole wounding deal is say I do it to my arm what then? It turns into more arm hair? My chest? My face? Can I make more beard hairs which are 3 times as thick as scalp hair? Does the area of skin I wound differentiate what hair is actual going to be produced do these guys even know really why it works? So many questions. To me personally I could be wrong but from my point of view Cots couldn't come up with anything amazing to cure hair loss so he basically took an idea people were already using made a fancy looking dermaroller that they could say was next gen and are commercializing it.

But that's ignoring the barbecue head guy....

 

[H]

But that's ignoring the barbecue head guy....

Whose this barbecue head guy?

 

[Dantes90]

I am guessing he is referring to this.

 

[H]

View attachment 64148 I am guessing he is referring to this.

Uh huh well then does the scalp have to be medium or well done? Has this been repeated? Could it be that when the follicles become miniaturized and the hair can't clear the epidermis the skin actually regenerates over the follicle stopping it from emerging. When wounding you are actually poking a hole deep enough to reach that already existing follicle allowing some to have the room they need to emerge again same could apply to that burn victim? It looks like he even had more regrowth then the dhurat study which would make sense since it evenly scraped off all of the epidermis and dermis instead of just shanking it multiple times. Food for thought just a idea. That would also explains why not every hole your make with the dermaroller produces a hair only some that were conveniently over a follicle just right.

 

[Bf20]

Follica can b*rn in hell , with there fraud products! had enough of this pathetic company.

Follica 2034 statement: We plan to conduct a pivotal trial within the next 5 years xxx!

 

[NewUser]

And so Cotsarelis et al have been studying Tregs, too, apparently.

In a June issue of Cell journal:
http://www.cell.com/cell/fulltext/S0092-8674(17)30529-9
Regulatory T Cells in Skin Facilitate Epithelial Stem Cell Differentiation

Highlights

• Treg activation in skin closely correlates with the HF cycle
• Tregs localize to HFSCs and play a major role in HF regeneration
• Tregs facilitate HFSC proliferation and differentiation to initiate HF cycling
• Treg expression of Jagged 1 is required for efficient hair regeneration

 

[NewUser]

Ok I missed that one by a kilometre. Cotsarelis is also listed as a co-author on the UCSF paper for immune cells triggering HFSCs to kick in and grow hair. Cots knows lots about hair.

 

[Noisette]

Just an another article about Rox Anderson / Follica from the Boston Globe newspaper (14 april 2017).
Follica will publish studies soon.

" Boston-based Follica, also based on his work, is working on stimulating hair growth, and will soon publish studies. I know at least some of us will be watching closely.... "


Source: https://www.bostonglobe.com/busines...ox-anderson/D0EII1bgiCAZA4HoqbHxCP/story.html

 

[H]

Just an another article about Rox Anderson / Follica from the Boston Globe newspaper (14 april 2017).
Follica will publish studies soon.

" Boston-based Follica, also based on his work, is working on stimulating hair growth, and will soon publish studies. I know at least some of us will be watching closely.... "


Source: https://www.bostonglobe.com/busines...ox-anderson/D0EII1bgiCAZA4HoqbHxCP/story.html

Can't believe he would lie...

 

[Xaser94]

Theres alot of conflicting info on the site redesign. I see that it says they will start the pivotal trial in the first half of 2018 and in another quote says in the second half. Whats even more funny is that in one of the photos of the pipeline it says Follica is done with phase 3 found here http://puretechhealth.com/our-science. But if u click "Explore out pipeline", there it is saying they still need to do phase 2b lol