Follica (first Time Ever Picture) - Exciting

tomJ

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Pretty sure the dosade for that is too low if applied topically
Sorry bro your wrong. For a few tye side effects are very real. Not only that but I also will get mucocele in my mouth. My saliva ducts will become blocked. I had to have surgery to cut it out. I gave up minoxidil for years and tried it again and same thing happened. And my chest hurt as well so it definitely was affecting my heart. I was it wasnt the case man but I clearly had negative physical reactions that cant be debated. And I told my doctor and he simply said, dont use it.
 

FilthyFrancis

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia
  • Follica plans to launch its Phase 3 program this year.
  • Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. T
  • he randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting

https://www.businesswire.com/news/home/20200603005934/en/
 

FilthyFrancis

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In 2017 (before deciding to go with the optimization study) Follica projected a 2018 release. Are they just randomly pulling these estimates out of their a-ss?

I would say 2023 as well, earliest.

They need to enroll the participants, process the phase 3 study (probably lasting between 6 months to a full year), treat and analyze the results, submit to FDA approval and go under the FDA's review, the latter taking a year on average.
 

Throwaway94

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How many people will actually go to a clinic for it as long as it's still just minoxidil and needling? For the price of one session I imagine you can get a Dr. Pen and 6 months worth of min easily

I'm sure it's a different story once they add more to their mix but as it is it's hard to be excited about their initial release date regardless of how near or far it might be
 

Tom4362

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2023 is more realistic.
Samumed started their trial 2019 and they will be available in 2021/2022
Yes but I think I read somewhere that Follica's trial will only be 3 or 6 months long while Samumed's trial takes 1 year

But I also think 2023 will be more likely
 

MrV88

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia
  • Follica plans to launch its Phase 3 program this year.
  • Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. T
  • he randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting

https://www.businesswire.com/news/home/20200603005934/en/

Would still say f*** yes, at least some news

T"selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen"

29-44% after 3 months
 

Rho Gain

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Only 33% of therapies move from Phase II to III, and 80% of those that go to Phase III come to market.

How many people will actually go to a clinic for it as long as it's still just minoxidil and needling? For the price of one session I imagine you can get a Dr. Pen and 6 months worth of min easily

Those of you who keep repeating, "needling and minoxidil" have absolutely no understanding of the protocol. It's not about the needling and the minoxidil, it's when and how you needle, and when you apply the minoxidil. Perfecting the insult and window to stimulate and maximize the regenerative response is what they've been studying for 20 years. If you think there isn't a difference between what Follica has been doing and what you've been doing with a dermapen and Rogaine, you simply don't comprehend the science behind this.

Follica is going to change the game. I was hoping they'd go commercial by late 2021/early 2022, but I'm sure C-19 wrecked their schedule. Still, given that they aren't testing a novel compound, and their previous trial protocols were three-month timelines, it's possible this could come out in early 2022 (they don't have to - and it's quite common not to - wait for approval to prime their marketing campaign and derm recruitment).
 
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John Difool

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Flipping to a safer topical like minoxidil is certainly going to accelerate their launch to the detrimental effect of less efficiency in the treatment.
 

Throwaway94

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Only 33% of therapies move from Phase II to III, and 80% of those that go to Phase III come to market.



Those of you who keep repeating, "needling and minoxidil" have absolutely no understanding of the protocol. It's not about the needling and the minoxidil, it's when and how you needle, and when you apply the minoxidil. Perfecting the insult and window to stimulate and maximize the regenerative response is what they've been studying for 20 years. If you think there isn't a difference between what Follica has been doing and what you've been doing with a dermapen and Rogaine, you simply don't comprehend the science behind this.

Follica is going to change the game. I was hoping they'd go commercial by late 2021/early 2022, but I'm sure C-19 wrecked their schedule. Still, given that they aren't testing a novel compound, and their previous trial protocols were three-month timelines, it's possible this could come out in early 2022 (they don't have to - and it's quite common not to - wait for approval to prime their marketing campaign and derm recruitment).

It's not that we don't understand the science, but they released their protocol already for for when and how to needle and when and how to apply minoxidil. This can, for all intents and purposes, be replicated at home despite what their marketing team would like you to believe. Even more so once it's released in clinics.
 

Rho Gain

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It's not that we don't understand the science, but they released their protocol already for for when and how to needle and when and how to apply minoxidil. This can, for all intents and purposes, be replicated at home despite what their marketing team would like you to believe. Even more so once it's released in clinics.

Can you link to the patent that provides the protocol in detail? Depths, density/# of needles, timing, etc.?
 

Rho Gain

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That is a difficult therapy to home-brew, especially when you are trying to administer it to yourself. That being said, it doesn't negate my point, which is this is more than "needling and minoxidil," it's the result of almost 20 years of research into maximizing the regenerative properties of wounding. Can you approximate that protocol? Sure. Can you replicate it exactly? Not likely, and given how exacting it is, that will almost certainly result in suboptimal results.
 

kiwi666

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That is a difficult therapy to home-brew, especially when you are trying to administer it to yourself. That being said, it doesn't negate my point, which is this is more than "needling and minoxidil," it's the result of almost 20 years of research into maximizing the regenerative properties of wounding. Can you approximate that protocol? Sure. Can you replicate it exactly? Not likely, and given how exacting it is, that will almost certainly result in suboptimal results.

I 100% agree with this.
 

NorwoodGuardian

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Follica should be commercialized at around the time that Histogen comes out, looking forward to the effect of their combination.
 

FilthyFrancis

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Follica should be commercialized at around the time that Histogen comes out, looking forward to the effect of their combination.

As much as I would like this to be true, it won't happen unless Follica gets very late.

Histogen is undergoing phase 1 trial. It won't be on the market, at least before 2025, if ever...
 
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