Follica Announce Expected Fda Filing In 2020

[Hippocrates21]

So in their latest investor presentation PureTech has announced that the start of the pivotal trial for Follica will be pushed back to the start of 2020.

But, and this is a big but, they have announced that they expect to file for FDA approval in 2020! Finally some movement!

Let the RAIN pour in mid 2021

 

[That Guy]

 

[BigOl'BaldingHead]

https://www.hairlosstalk.com/interact/threads/follica-pivotal-study-and-fda-filing-in-2020.124090/

 

[MrJolly26]

But do they talk about the device or some other kind of product like a pill or a lotion (something such as minoxidil or whatever)? Thanks!

 

[Hippocrates21]

https://www.hairlosstalk.com/interact/threads/follica-pivotal-study-and-fda-filing-in-2020.124090/

Ah f***, maybe it’s bad news then, cos they’ve slyly changed that date in image 2 from the pivotal trial starting in 2019 to now starting in 2020. At least they haven’t changed the FDA filing date.

 

[Hippocrates21]

When will see this on the market though?

I’m guessing/hoping for late 2021

 

[kiwipilu]

Hallelujah

 

[Tom4362]

I am wondering whether it will also be available in Europe, cant seem to find any info about that...

 

[Tomtom21]

OP link to presentation ? @Hippocrates21

 

[badhabiz]

I am wondering whether it will also be available in Europe, cant seem to find any info about that...

"There was a rise in the number of NTDs approved for both the US and EU markets from 36 in 2017 to 49 in 2018. This indicates that the joint application strategy was more popular than previous years." NDA site

 

[hairloss_user]

So assuming the treatment is safe which it should be, FDA should have no problems approving it 2021? And then after that it shouldn't take long for it to be released??

 

[MeDK]

Is there some clinical trail results anywhere from their optimisation study?

Its easy to write "significant" change, but what are the numbers really.

 

[That Guy]

Is there some clinical trail results anywhere from their optimisation study?

Its easy to write "significant" change, but what are the numbers really.

Within the company

 

[Rho Gain]

Is there some clinical trail results anywhere from their optimisation study?

Its easy to write "significant" change, but what are the numbers really.

It's weird how many people ask this question, when there has been a widely-known answer for years. While the results of the optimization study are proprietary, Follica reported many years ago that it was achieving 25 terminal hairs per cm2. Assuming they improved on that by say, 10-20%, we're looking at significant regrowth.

I've said it before and I'll keep saying it: Follica will be the first new 21st century protocol to hit the market, and for low NWs (3>), it's going to be a life-changer and a life-saver.

 

[That Guy]

It's weird how many people ask this question, when there has been a widely-known answer for years. While the results of the optimization study are proprietary, Follica reported many years ago that it was achieving 25 terminal hairs per cm2. Assuming they improved on that by say, 10-20%, we're looking at significant regrowth.

I've said it before and I'll keep saying it: Follica will be the first new 21st century protocol to hit the market, and for low NWs (3>), it's going to be a life-changer and a life-saver.

This is literally the only reason I've held off on the transplant.

For <NW4 this should be preferable to a transplant in both appearance and price.

 

[Rho Gain]

This is literally the only reason I've held off on the transplant.

For <NW4 this should be preferable to a transplant in both appearance and price.

Even if I were a high Norwood, I would hold off on a transplant until Follica's results are released. One of the great unknowns is, can it grow hair in scar tissue? Because if you get a hair transplant now and scar up your scalp, then Follica drops in a year and a half (two at most; they will be setting up the logistics in tandem with the filing so that the day they get clearance will be the day they start treatment) and averages 2-3NW gains, you're going to really regret it. Let's say you're currently a NW4 - what's one more year to you? Follica is minimally invasive, while a hair transplant certainly is not; by the time you've healed up from your hair transplant, Follica will be close to going commercial. And then there is the compoundability question. There's just no compelling reason to get a hair transplant until we know what Follica can deliver, and if you've been significantly bald for years, another one or two isn't going to change your life.

PS. Look at Puretech's 1yr chart; 60% gain in 12 months. The secret's out. I remember looking at it in 2017 and thinking, "might be worth the risk," but I got burned on REPCF and decided not to speculate on biotech. Looks like I picked the wrong horse in that race (even though I always thought Follica was the much stronger candidate, it's just the upside if REPCF paid off was so much greater).

 

[Fgsfds]

It's weird how many people ask this question, when there has been a widely-known answer for years. While the results of the optimization study are proprietary, Follica reported many years ago that it was achieving 25 terminal hairs per cm2. Assuming they improved on that by say, 10-20%, we're looking at significant regrowth.

I've said it before and I'll keep saying it: Follica will be the first new 21st century protocol to hit the market, and for low NWs (3>), it's going to be a life-changer and a life-saver.

Get real.

finasteride's result per cm2: 16
CB's result per cm2: ~12

Are people regrowing norwoods with finasteride and CB? No. I have 30% of the hair I had when I started finasteride 8 months ago, in fact.

Expect this to do probably 50% more than regular ol' microneedling. If you're not getting any results with that now then tough.

dutasteride or death

 

[Tom4362]

(two at most; they will be setting up the logistics in tandem with the filing so that the day they get clearance will be the day they start treatment) and averages 2-3NW gains, you're going to really regret it.

How do you know this?

 

[fixthis]

For those outside USA (I live in the UK) how could we go about getting this?

 

[MeDK]

It's weird how many people ask this question, when there has been a widely-known answer for years. While the results of the optimization study are proprietary, Follica reported many years ago that it was achieving 25 terminal hairs per cm2. Assuming they improved on that by say, 10-20%, we're looking at significant regrowth.

I've said it before and I'll keep saying it: Follica will be the first new 21st century protocol to hit the market, and for low NWs (3>), it's going to be a life-changer and a life-saver.

Its apparently not that widely known, because I can't find any article stating what you wrote.

Also a study tend to tell us if its a best case scenario if we assume the 25 terminal hairs pr. cm2, or if its average, median, top 10% best respondents what ever it might be.and for how long do the hairs stay? is it permanent, 1-2 years what is the timeframe for the new hairs.

All i found is a claim from 2013 where they talk about increasing hair follicles with 2-3 fold (its based on mice study)

On their own site they base the results on a study on 20 males, where the claim about "significant" regrowth is being talked about.

So would be awesome if you could find a direct link to the claim about the 25 cm2 terminal hairs, and its not based on a mouse study.