Isn’t Follica Supposed To Be Released This Year?

[joely87]

Please see title

 

[MrV88]

Please see title

Sorry but I can't resist:

Please see the search button....

 

[Ikkaku]

SUPPOSED !!! So maybe in 2 years.

 

[br1]

While you wait, you can browse their nice website, full of bright pictures.

 

[tjnpdx]

Sorry but I can't resist:

Please see the search button....

 

[NewUser]

How about we look at this way. If it works better than the big three, then waiting until 2020-21 would be worthwhile. And Cotsarelis' prediction that new treatments are on the way would be fulfilled. And waiting isn't costing us a dime in snake oil elixirs or things that don't work in general. Patience is a virtue of royalty. Glass is half full. Good things come to those who wait and all that.

 

[Baldybald1]

This conversation is very funny because some people are saying if it works !?! Man it already showed that it significantly work much better than the big 3 combined. Now the reason that they are taking that long time is that they are trying to improve it by adding more compounds to get the max result.

Mark my word, a lot of us will forget about Tsuji and shesiedo because some of us will get good coverage ( Norwood,1,2,3,4 and maybe 5) or some will combine it with hair transplant (Norwood 5,6,7). Problem solved !!!

 

[Blackber]

This conversation is very funny because some people are saying if it works !?! Man it already showed that it significantly work much better than the big 3 combined.

Yea? Where did they show that?

To my recollection they haven’t shown anything, we don’t even know what the definitive treatment is.

As far as I know we’ve only seen results from the Duhrat study which is far from conclusive.

 

[That Guy]

Possibly.

The only opinions really worth putting any stock in is any official statements provided by the company because ultimately, they know more about what they're doing than any of us do.

In 2016 they expected to get market clearance in 2017 with a release as soon as 2018. In 2017, they still expected a possible release in 2018, but wound up experience about a six months setback on the beginning of their pivotal trial, which is apparently only now needed on the in-office device. At that time, they still felt a 2018 release is possible if their pivotal starts in this half of 2018 as previously announced.

So with the setback, a late 2018 release date is still theoretically possible if they meet their current target, though 2019 is probably more likely.

That's the only reasonable prediction to make at present. Everything else, like 2020-21, specific quarters etc, is purely conjecture unless anyone is privy to some sort of insider information.

Which isn't likely.

 

[Baldybald1]

Possibly.

The only opinions really worth putting any stock in is any official statements provided by the company because ultimately, they know more about what they're doing than any of us do.

In 2016 they expected to get market clearance in 2017 with a release as soon as 2018. In 2017, they still expected a possible release in 2018, but wound up experience about a six months setback on the beginning of their pivotal trial, which is apparently only now needed on the in-office device. At that time, they still felt a 2018 release is possible if their pivotal starts in this half of 2018 as previously announced.

So with the setback, a late 2018 release date is still theoretically possible if they meet their current target, though 2019 is probably more likely.

That's the only reasonable prediction to make at present. Everything else, like 2020-21, specific quarters etc, is purely conjecture unless anyone is privy to some sort of insider information.

Which isn't likely.

Thanks for clarifying my point, and yes they know what they are doing but we know nothing !!

Have a good night everybody and am out of here

 

[Jonnyyy]

So cure for those who need the extra density 2021
Cure for norwood 7s 2020, lmfao

 

[That Guy]

If they don't start the pivotal trial - which will almost certainly take more than a year at a minimum - until Q2 2018, how could they possibly release by Q4 2018, much less 2019?

Their previous estimations still considered the pivotal, though. So they must not expect it to take a tremendous amount of time.

You may very well wind up being correct.

I'm just saying that — for now — it's just best to see how this year pans out for them.

 

[Blackber]

If they don't start the pivotal trial - which will almost certainly take more than a year at a minimum - until Q2 2018, how could they possibly release by Q4 2018, much less 2019? 2020-1 is a perfectly reasonable estimation given where we know they are and the time it will take for them to get where they are headed - if it works as planned.

With regards to pivotal trials, this is worth reading: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4317185/:

"The median duration of pivotal clinical trials was 3 years, ranging from 3 months to approximately 7 years. Trials had a median primary outcome measure evaluation time of one year and a median enrollment of 297 patients. The median FDA review time was 1 year and 3 months."

Even if they run one of the fastest trials in history, they're still going to be waiting a year for the FDA to review. In all likelihood, it will take several years after the commencement of the trial for them to get to market.

I don't want to give the impression that I'm skeptical of Follica, because I'm not. I've just always felt that they - and the rest of the promising research - are 2020+ technology, though not much beyond that. I will, however, rejoice a bit when they do start the trial; that will be a major milestone in hair loss research, as I believe it will be the first time a protocol has entered a final stage trial since finasteride more than 25 years ago.

My opinion is that you will be able to go into a derm's office and get the Follica treatment in late 2020 or early 2021 - it's not likely to take longer than that, as long as it works.

Wholeheartedly agree. I'm not trying to be a Debbie downer but too many people on this forum think that as soon as trials are complete that it's going to take a month or two for them to have a commercially available treatment and that's just not the case in my opinion. It's going to take them months and months, to go through data, make a decision as a company whether they want to pursue commercial approval form the FDA, go through FDA approval, get FDA approval and then start manufacturing their product and setting up their treatment network.

Follica may be a little different than other companies if we assume they're using compounds already approved and only need device approval but its going to take more time than most people here believe it will.

 

[br1]

How about we look at this way. If it works better than the big three, then waiting until 2020-21 would be worthwhile. And Cotsarelis' prediction that new treatments are on the way would be fulfilled. And waiting isn't costing us a dime in snake oil elixirs or things that don't work in general. Patience is a virtue of royalty. Glass is half full. Good things come to those who wait and all that.

Anything that comes our way is good. We just want it now and for it not to be another scam.

 

[Noisette]

No. Final testing (maybe?) starts Q2 (supposedly), assume readout Q4 ‘19 (maybe), and if it worked, commercialization Q3 ‘20/ Q1 ‘21. If it works (meaning, significantly better than currently available treatments AND at a price point that supports a market).

If they don't start the pivotal trial - which will almost certainly take more than a year at a minimum - until Q2 2018, how could they possibly release by Q4 2018, much less 2019? 2020-1 is a perfectly reasonable estimation .

Maybe you are right. It's safe to say that but I'm not sure that It would take more than 2 years to release the first version of their products.

I think that it would be possible for them, to hit the market at the beginning of 2019 (in the best scenario if their pivotal trial begin this H1)
Optimist yeah I know

Why I think that ? because of this :
- Initialy, january 2017, they have written that the Pivotal trial of in-office device begin in the first quarter of 2017 with a possible clearance of the FDA in the last quarter.
So, in this case, Follica expects a clearance in a short term.

- Don't forget they have completed already a pivotal trial according to this document
(because they are expecting the Pivotal data In-market testing of at-home device in the second quarter of 2017).

And that's why, for Biocentury, Follica is in Phase II/III.
So, if they have completed a pivotal trial, they have to be in contact with the FDA, in order to share their data.


- The Pivotal trial of in-office device would begin in 1H of 2018, if everything is ok.

source: http://bciq.biocentury.com/companies/follica_inc

 

[sunchyme1]

you are spaming for years now. cant watch your timelines anymore. all your findings lead to nowhere!!! please leave the community noisette, there will be no solution for baldness, so you should stop giving false hope to everybody.

u nw7 bro?

 

[Bad_Wolve]

u nw7 bro?

haha i am done with this scams out there, now i know that there wont be a solution the next 100 years and you all should accept this fact.

 

[Bad_Wolve]

hahahahahaha you guys are disliking my post for telling the truth, thats amazing. reminds me on george orwell 1984.

 

[Dontwannabeabetabob]

Thought Brotzu was supposed to be coming out this March? I've heard nothing about a Follica release this year.

 

[Spanishboy97]

hahahahahaha you guys are disliking my post for telling the truth, thats amazing. reminds me on george orwell 1984.

That's an odd example but ok