Puretech Health - 2017 Annual Report (2018-04-16)

Mykonas

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But pouring tens of millions in research and development, and going through the FDA processes into something that doesn't do anything does not happen. Maybe in Mexico (Histogen) or the Bahamas, but in the United States and Canada who actually have rigorous protocols involving these kinds of things.

*coughs* prp, laser treatments, other bullshit cosmetic treatments *coughs*
 

fuDHTck

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Well, I'd say that given their previously stated timeline and the fact that they are in the pre-pivotal as planned, I'd say that sometime next year is most likely.

That is of course assuming they start the full-on, Phase III pivotal within the next couple months. They said they planned to initiate that in the first half of 2018, and a couple months away from that deadline.



All the ones you can easily find discussed for the last five or more years on this site. By the way, the doctor with the most famous and successful study regarding the issue recently became a board member of Follica.

Also regarding minoxidil that you or someone was complaining about earlier. Yeah, minoxidil likely will be one of their compounds. But again, this has been successful in the neogenesis studies and you are literally complaining about them using the only drug presently on the market that CAN grow hair!



Yes, welcome to business and marketing.

Rocks put in a tiny box cost absolutely nothing to research and manufacture. Same with "essential" oils or Chinese laser helmets.

But pouring tens of millions in research and development, and going through the FDA processes into something that doesn't do anything does not happen. Maybe in Mexico (Histogen) or the Bahamas, but in the United States and Canada who actually have rigorous protocols involving these kinds of things.
I know most people here love this user but what he is saying here is just impossible. If they havent started phase III yet then it is impossible it will come out next year. That's just not how mrdicsl trials work.
 

soo

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whoever did this must be an evil human being
 

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That Guy

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I know most people here love this user but what he is saying here is just impossible. If they havent started phase III yet then it is impossible it will come out next year. That's just not how mrdicsl trials work.

The last trial is for a freakin' needling device and that's it.

In 2016, they said they planned to start the pivotal in 2017 with a market launch in 2018 most likely. They suffered about a six month setback on the timeline, so that should set them back about six months from their previous target; give or take.

But I'm sure you know the market and the process better than the people who've actually been through it as to make an accurate guess.
 

Noisette

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Please, sorry for my long post, this one :p

I don't want to mislead you, I just want to give you some informations :) If you want to give your thoughts on it, please share it :)


Hey, great post!! I want to know what is exactly follica. Right now i know its a wounding device + a growth treatment.

But what is the growth treatment.. minoxidil ? I hope not... ! thx

It's hard to say for sure if it will be minoxidil. But on their patent, they have tested differents compounds like Bimatoprost on their clinical trials .
We can say that they have several compounds for the first generation. @That Guy has explained very well :) the next generation compounds are testing in order to increase the number of neogenic hairs, terminal hairs.

Here, they have already "completed its clinical-stage development of a next-generation device and drug combination product "
So they have a drug combination product = the first generation of compounds.
It's nice to see that they are already on the next generation of compounds.

Here we can read an interview of Daphne Zohar :
" we are using existing compounds previously approved for systemic chronic use and reformulating them for topical acute use. We know these compounds are safe in people."

There's no questioning the market demand. A new therapy that could safely and effectively treat male and female pattern hair loss would swiftly seize a huge market. And Zohar says the same technology can potentially be applied to hair removal, skin pigmentation and more. But don't ask her to name the original compounds the company is reformulating for novel use - that's a trade secret for now
."

So Follica have reformulated the existing compounds :)

Source: https://www.fiercebiotech.com/special-report/emerging-drug-developer-follica


Do you mean clearance to start the study? Because there is no way in hell this is released by the end of the year if they haven't even started recruitment for the phase 3 study. Recruitment -> Approval for a phase 3, a 2 year timeline would be optimistic. So spring of 2020...

What do you think about their previously timeline ? they expected to have a regulatory clearance (an FDA approval at the end of 2017 ?) . A short timeline.

Follica.jpg


We don't know the relationship between Follica and the FDA. Maybe they have a " Fast Track designation"

"
A drug that receives Fast Track designation is eligible for some or all of the following:

  • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met "

More details on what is a Fast Track : https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm


whoever did this must be an evil human being
Hahaha :)

Nothin' gets my dick harder than a Noisette post
.
LMAO

No, it's not them - I was thinking that name, but I confused it with another mysterious company that is working with Follica. In any regard, they have a website that lists a Androgenetic Alopecia compound in pretrial research.

I wish we had a better look at the dermabrasion device - I know there's the one picture, but it looks pretty rough compared to all the illustrations of the drug applicator. I'd love to have some idea of how abrasion is achieved, and if it's through needling, how deeply it does it.

Maybe Kythera ? According to puretech, Doctor Cotsarelis is a founder of Kythera.
upload_2018-4-19_0-20-23.png
 
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SheddieMurphy

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hate being cynical and negative, but all this looks like their intention is to drag their "research" out until someone comes up with an illuminating scientific breakthrough which they will then be ready to utilize and incorporate in their hypothetical treatment

tell me this doesnt look like it. as time passes, their narrative becomes less and less concrete product-oriented
 

Rolandconil

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but still the questions to the follicle remain. suppose you have a Norwood 7 for 3-4 years, you start to be treated with Follica. By injury (device 1) you have hair and cosmetically covers your head. What happens next? How long will support work
these hair? Minoxidil for many does not work in 3-5 years. topical seti or finasteride?
someone tells me that these new hair will not fall out, but then why is the device 2 with a massage applicator for applying medicines?

and in general why at the upcoming congress Cotswarelis will talk about PRP?
 

That Guy

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Minoxidil for many does not work in 3-5 years.

It's not really definitively known why that is. There is a reason why it would work for some people and not others. But wounding studies that have employed it have definitely had more success than just minoxidil patients, so it stands to reason minoxidil by itself may not be enough for most people. We can also determine they will be using at least two compounds from the info on the site. So I wouldn't worry about this, honestly.

but still the questions to the follicle remain. suppose you have a Norwood 7 for 3-4 years, you start to be treated with Follica. By injury (device 1) you have hair and cosmetically covers your head. What happens next? How long will support work
these hair? Minoxidil for many does not work in 3-5 years. topical seti or finasteride?
someone tells me that these new hair will not fall out, but then why is the device 2 with a massage applicator for applying medicines?

The only people who may have a study that can answer that is Follica and obviously that information is with the powers that be.

There doesn't seem to presently be a published study that is old enough to determine if the hair is "dht resistant or not". There is a case to be made for "not" since it's being created from the same skin that would have created the original hair, as it's been explained to me. The good news is, that doesn't really matter since for most people, it will still take years to lose that hair again and the process can be done again.

I know occulus insists that it wouldn't make a NW4 a NW1 again, but I personally can't find any reason why it theoretically couldn't.

As far as I can tell, wounding neogenesis should work anywhere across the scalp and I've yet to see any sort of argument as to why repeated treatments wouldn't continue to produce more hair after the fact. There just doesn't seem to be any study that's gone on near long enough to really see what the endgame of this is. It's more like they just go for a few weeks or a couple months and then follow up a few months later and are like "yeah it worked".

The good news is that despite wounding + minoxidil taking a primitive form in these studies, there have been some truly fantastic results from it; certainly better than what most of us could hope for from conventional treatments.

But it's a shame that no one has bothered to really follow through with it to see what the upper limits of it could be, and I'm pretty excited to see what a more advanced, well-researched form of the procedure can offer.
 

MrV88

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Please, sorry for my long post, this one :p

I don't want to mislead you, I just want to give you some informations :) If you want to give your thoughts on it, please share it :)




It's hard to say for sure if it will be minoxidil. But on their patent, they have tested differents compounds like Bimatoprost on their clinical trials .
We can say that they have several compounds for the first generation. @That Guy has explained very well :) the next generation compounds are testing in order to increase the number of neogenic hairs, terminal hairs.

Here, they have already "completed its clinical-stage development of a next-generation device and drug combination product "
So they have a drug combination product = the first generation of compounds.
It's nice to see that they are already on the next generation of compounds.

Here we can read an interview of Daphne Zohar :
" we are using existing compounds previously approved for systemic chronic use and reformulating them for topical acute use. We know these compounds are safe in people."

There's no questioning the market demand. A new therapy that could safely and effectively treat male and female pattern hair loss would swiftly seize a huge market. And Zohar says the same technology can potentially be applied to hair removal, skin pigmentation and more. But don't ask her to name the original compounds the company is reformulating for novel use - that's a trade secret for now
."

So Follica have reformulated the existing compounds :)

Source: https://www.fiercebiotech.com/special-report/emerging-drug-developer-follica




What do you think about their previously timeline ? they expected to have a regulatory clearance (an FDA approval at the end of 2017 ?) . A short timeline.

View attachment 85831

We don't know the relationship between Follica and the FDA. Maybe they have a " Fast Track designation"

"
A drug that receives Fast Track designation is eligible for some or all of the following:

  • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
  • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met "

More details on what is a Fast Track : https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm



Hahaha :)


LMAO



Maybe Kythera ? According to puretech, Doctor Cotsarelis is a founder of Kythera.
View attachment 85830

Hey Noisette, thanks again ;)

Do you have any idea if this treatment could work on FUE/FUT scars or in somehow scarred areas?
 

Baldybald1

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So here is the thing, the current compounds will be better than the available treatment like 3 or 4 times more. The next t generation compound will give a full head of hair.
 

br1

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Dude that's pretty good for his age. Almost 60 with an intact hair line and like a NW3v? I'd easily trade with him. He's not bald. He's balding still, at his age. If he pulls off Follica, then he can probably fill that spot within a year.

Sorry but that is "bald" not balding. He's bald.
 
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