Even 5 years for Follica\'s market lauch looks way to optimistic

Stem cell; cell based hair therapy
21

» » I can assure you they will either license gefinitib or create their own
» » from scratch. Considering benefits of their proprietary drug,
»
» The company has 4 friggin’ employees, and a shoestring budget. They don’t
» have the expertise, the time (10 years), money (hundreds of millions of
» dollars), or any other resources to synthesize and test a new drug. Christ,
» they are not a drug company.
»
» » I am pretty sure they will do their own EGF inhibitor.
»
» How do you propose they do that? With what people and what money? Not to
» mention, THEY ALREADY SAID THEY ARE USING EXISTING DRUGS. Are you
» dense, debris? No offense, of course. :smiley:

its either working or not, if it will be promisigin, someone will invest the money. licensing would not be cheap anyway, and trials would be necessary because of the serious sideefects.

I see it unlikely that FDA would let them just use it for anything else then it is currently approved for without any further trials. Gefinitib got approved only because its for cancer. A cancer patient is dieing, it does not matter if he dies from lung disease. Hairloss is cosmetic problem.

So the option are:

  • trials with gefinitib and license the drug and tolerate money leaking to gefinitib usage.

  • trial random other known EGRF inhibitor and avoid licensing, the leaks of money and practically have easily enforcable monopoly.

I think that licensing gefinitib is an option for them, but I see it more likely that if it really works, they will go with their own drug instead. All in all both options mean trials and a product thats more then 5 years from now on so it really does not matter.

22

»
» its either working or not, if it will be promisigin, someone will invest
» the money. licensing would not be cheap anyway, and trials would be
» necessary because of the serious sideefects.
»
» I see it unlikely that FDA would let them just use it for anything else
» then it is currently approved for without any further trials. Gefinitib got
» approved only because its for cancer. A cancer patient is dieing, it does
» not matter if he dies from lung disease. Hairloss is cosmetic problem.
»
» So the option are:
»
» - trials with gefinitib and license the drug and tolerate money leaking to
» gefinitib usage.
»
» - trial random other known EGRF inhibitor and avoid licensing, the leaks
» of money and practically have easily enforcable monopoly.
»
»
» I think that licensing gefinitib is an option for them, but I see it more
» likely that if it really works, they will go with their own drug instead.
» All in all both options mean trials and a product thats more then 5 years
» from now on so it really does not matter.

23

» I think that licensing gefinitib is an option for them, but I see it
» more likely that if it really works, they will go with their own drug
» instead.

FOLLICA HAS SAID NUMEROUS TIMES THEY ARE USING EXISTING DRUGS. WHAT DON’T YOU UNDERSTAND? Sheesh. :frowning:

24

» » I think that licensing gefinitib is an option for them, but I see it
» » more likely that if it really works, they will go with their own drug
» » instead.
»
» FOLLICA HAS SAID NUMEROUS TIMES THEY ARE USING EXISTING DRUGS. WHAT DON’T
» YOU UNDERSTAND? Sheesh. :frowning:

If they use existing drugs, they can skip the pre-clinical and the IND phase. But they can’t skip the NDA phase. You need a new NDA every time you want to market an existing drug for a new condition.

Gefinitib is out there and being used, but isn’t approved for hairloss. While a doctor could take it upon himself to use it for whatever he wants to, Follica would not be able to package the drug up in their kit for the condition of hairloss. Since they seem to be talking about a topical, it seems that’s the only way they’d be able to do it.

An NDA could happen in less than 5 years, though.

25

TAGOHL,

In an aside from the discussion about Follica’s potential approval from the FDA, if your experiment doesn’t pan out and mine didn’t either, I think I will try another route if/when I try it again (probably after the new year starts).

I think I’d keep it as close to the follica experiments as I possibly could. I’d manually abrade to emulate the abrasion that they performed. I’d monitor the healing and wait for the abraded area to crust and start peeling, then I’d take both getfitinib and cyclosporin for about four straight days. I dont think I’d shampoo or even get my hair wet during this time at all…which might mean no washing of the hair for about 7-8 days. That way all potential variables would be addressed. I hope you get something in about a month ‘up there’ though, because I really wouldn’t want to go through with that. I honestly think the first two or three days post re-epilithialization is the “important time” and if the epidermal stem cells decide to build hairs post-disruption, and they begin to do so, they will complete the job unless some “anti-infective” (what the patent says) is applied. It would be my “last” try, because if that didn’t work, I’d just wait and see what Follica came up with. That would be about as close an emulation to the two regrowth photos and the experimental results with human skin on SCID mice as one could do at home.

On Follica’s approval> Its almost impossible to discuss that here without people just being ridiculous about it. The company (Zohar) has said one thing, and Dr. Nancy Snyderman, medical correspondent for NBC News, said 2-3 years and “maybe sooner”. I know erlonitib (what follica would probably acutally be using) is already approved in people for usage and tacromilus and pinecromilus are approved for eczema and psoriasis. Dermabrasion and/or laser resurfacing (Rox Anderson’s role with the company?) is already legal. Even if these things are systemically absorbed to a point, they are already approved for internal usage also. It WILL be approved if it works, whether it be in 2 years of 6 years.

We have to also consider the possiblility that follica just might (if it proves necessary) INJECT the drugs like they did with the mice, using the same compounds that were used in the tests, if they cant formulate a topical that adequately gets through the crusting skin near the embryonic window.

All we can really do now for a few weeks is wait and see if we got some growth. I hope you did, as I have a bad feeling that alcohol in the minox foam at day 4 screwed my experiment up.

26

» TAGOHL,
»
»
» In an aside from the discussion about Follica’s potential approval from
» the FDA, if your experiment doesn’t pan out and mine didn’t either, I think
» I will try another route if/when I try it again (probably after the new
» year starts).
»
» I think I’d keep it as close to the follica experiments as I possibly
» could. I’d manually abrade to emulate the abrasion that they
» performed. I’d monitor the healing and wait for the abraded area to
» crust and start peeling, then I’d take both getfitinib and cyclosporin
» for about four straight days. I dont think I’d shampoo or even get my
» hair wet during this time at all…which might mean no washing of the
» hair for about 7-8 days. That way all potential variables would be
» addressed. I hope you get something in about a month ‘up there’ though,
» because I really wouldn’t want to go through with that. I honestly think
» the first two or three days post re-epilithialization is the “important
» time” and if the epidermal stem cells decide to build hairs
» post-disruption, and they begin to do so, they will complete the job unless
» some “anti-infective” (what the patent says) is applied

I could not understand this point benji , I thought anti-microbials are included in the patent and the process !

. It would be my
» “last” try, because if that didn’t work, I’d just wait and see what Follica
» came up with. That would be about as close an emulation to the two regrowth
» photos and the experimental results with human skin on SCID mice as one
» could do at home.
»
»
»
» On Follica’s approval> Its almost impossible to discuss that here
» without people just being ridiculous about it. The company (Zohar) has said
» one thing, and Dr. Nancy Snyderman, medical correspondent for NBC News,
» said 2-3 years and “maybe sooner”. I know erlonitib (what follica would
» probably acutally be using) is already approved in people for usage and
» tacromilus and pinecromilus are approved for eczema and psoriasis.
» Dermabrasion and/or laser resurfacing (Rox Anderson’s role with the
» company?) is already legal. Even if these things are systemically absorbed
» to a point, they are already approved for internal usage also. It WILL be
» approved if it works, whether it be in 2 years of 6 years.
»
» We have to also consider the possiblility that follica just might (if it
» proves necessary) INJECT the drugs like they did with the mice, using the
» same compounds that were used in the tests, if they cant formulate a
» topical that adequately gets through the crusting skin near the embryonic
» window.
»
»
» All we can really do now for a few weeks is wait and see if we got some
» growth. I hope you did, as I have a bad feeling that alcohol in the minox
» foam at day 4 screwed my experiment up.

27

» » I think that licensing gefinitib is an option for them, but I see it
» » more likely that if it really works, they will go with their own drug
» » instead.
»
» FOLLICA HAS SAID NUMEROUS TIMES THEY ARE USING EXISTING DRUGS. WHAT DON’T
» YOU UNDERSTAND? Sheesh. :frowning:

ok, they may license gefinitib and do shorter trials. but even in that case 5 years is the soonest I’d expect anything. Matbe 4 and half now. They have not even started testing it on humans yet and I’m quite sure FDA will want them to rule out the lung issue with absolute certainity before approving it for hairloss.

28

» » »
» I could not understand this point benji , I thought anti-microbials are
» included in the patent and the process !

From the patent:

"Optionally, the skin, following the epidermal disruption, is not contacted for a period of time with any substance (e.g., ointment, a bandage, or a device) that is normally administered to an abrasion or wound to prevent infection.

Here the skin is not contacted with any substance until, for example, the ■ •■ - epidermal disruption -has healed (e.g., any time between 2 days and 3 weeks). Alternatively, the skin can be contacted with a cast or bandage (e.g., resulting in increased blood flow to the disrupted skin or decreased transdermal water loss or decreased mass transfer of gases into the skin and from the skin (e.g. oxygen, carbon dioxide, water vapor), decreased heat transfer from the skin (e.g. resulting in an increased temperature of the skin surface) or increased pressure on the skin.

Prior to disruption, the skin can depilated or epilated. The depilation or epilation can be accomplished through, for example, waxing, plucking, an abrasive material, a laser, electrolosis, a mechanical device, or thioglycolic acid."

The disruption of the epidermis can be induced between 3-12 days (e.g., 4-12, 5-12, 4-11, 6-11, 6-10, 6-9, 7-8, 5-11, 5-10, or 7-10 days) prior to the addition of the compositions of the invention."

I want to keep it as close to the vest as possible to eliminate any uneccessary threats to the viability of the experiment. I dont know what carriers or precise anti-microbials Follica intends to use. If I did one, it would probably be internally. The epidermal stem cells that make the hair will be doing so VERY close to the skin’s surface, and henceforth will be suceptible to intereference from outside chemical intervention. I wish to avoid this.

29

The anti-microbial thing confused me too.

I’ve ordered some diphenhydramine (antihistamine). Next experiment I plan on depilating, then wait 3 days. Sand the scalp and begin taking diphenhydramine and quercetin orally. I’m not going to touch the scalp with any substance until the scabs begin to fall off (whatever day that is). I am then going to cease Quercetin and begin applying the topical of tannic acid, lithium orotate, caffeine and dmso mixed in an alpha lipoic acid cream. I’m leaving out the roxithromycin during the embryonic window. I may include it in a topical after the embryonic window has closed. I’m goijng to apply the topical for 10 days after epithelization. I am then going to change to the minox, copper peptides and roxithromycin topicals to coax the (hopefully) new/regenerated follicles.
Hope to begin in a couple of weeks. At this moment, there is no use taking photos as I have no gains from the current experiment.

30

I agree, someone needs to replicate this as close as possible to what follica did in their experiments.
I think it may be better to try and knock up a topical Gefitnib concocsion.

31

» If I did one, it would probably be internally. The epidermal stem cells
» that make the hair will be doing so VERY close to the skin’s surface, and
» henceforth will be suceptible to intereference from outside chemical
» intervention. I wish to avoid this.

I think where I went wrong this time was applying a topical immediately after wounding. The previous time I had left it until at least the scabs were forming. I think it may be crucial not to interfere topically for at least the first few days.

32

» The anti-microbial thing confused me too.
»
» I’ve ordered some diphenhydramine (antihistamine). Next experiment I plan
» on depilating, then wait 3 days. Sand the scalp and begin taking
» diphenhydramine and quercetin orally. I’m not going to touch the scalp with
» any substance until the scabs begin to fall off (whatever day that is). I
» am then going to cease Quercetin and begin applying the topical of tannic
» acid, lithium orotate, caffeine and dmso mixed in an alpha lipoic acid
» cream. I’m leaving out the roxithromycin during the embryonic window. I may
» include it in a topical after the embryonic window has closed. I’m goijng
» to apply the topical for 10 days after epithelization. I am then going to
» change to the minox, copper peptides and roxithromycin topicals to coax the
» (hopefully) new/regenerated follicles.
» Hope to begin in a couple of weeks. At this moment, there is no use taking
» photos as I have no gains from the current experiment.

if you are using tannic acid, why the caffeine, isn’t that doubling up uneccessarily? Some of the guys who abraded and used Caffeine at HLT didn’t have luck…

you might give your scalp 2-3 weeks to “heal” from the first abrasion…you could be running the risk of scarring or discoloration up there by repeatedly removing the epidermis so soon after it healing. Copper peptides applied for a few weeks might help the skin rebuild in get in good shape. Abrading the skin is a rough procedure on the dermis. It also probably takes a few days for those same peptides to be “out” of the skin before you abrade it. If you just used folligen or tricomin for instance and then abraded the skin, the peptides would be present deeper in the skin’s layers, probably aiding “repair” signals in response to the wound instead of “rebuild” (what we want) signals in the skin. One might consider being off the peptides 3-4 days before wounding.

Abrasion would have to be very delicately performed for the window to be open by day 3 in retrospect. That is probably the very soonest it could happen. I imagine days 4-7 or so is when the embyonic window is really going to be opening for most of us as we dont have precision abrasion instruments at our disposal.

33

» » The anti-microbial thing confused me too.
» »
» » I’ve ordered some diphenhydramine (antihistamine). Next experiment I
» plan
» » on depilating, then wait 3 days. Sand the scalp and begin taking
» » diphenhydramine and quercetin orally. I’m not going to touch the scalp
» with
» » any substance until the scabs begin to fall off (whatever day that is).
» I
» » am then going to cease Quercetin and begin applying the topical of
» tannic
» » acid, lithium orotate, caffeine and dmso mixed in an alpha lipoic acid
» » cream. I’m leaving out the roxithromycin during the embryonic window. I
» may
» » include it in a topical after the embryonic window has closed. I’m
» goijng
» » to apply the topical for 10 days after epithelization. I am then going
» to
» » change to the minox, copper peptides and roxithromycin topicals to coax
» the
» » (hopefully) new/regenerated follicles.
» » Hope to begin in a couple of weeks. At this moment, there is no use
» taking
» » photos as I have no gains from the current experiment.
»
»
» »
» if you are using tannic acid, why the caffeine, isn’t that doubling up
» uneccessarily? Some of the guys who abraded and used Caffeine at HLT didn’t
» have luck…
»
» you might give your scalp 2-3 weeks to “heal” from the first
» abrasion…you could be running the risk of scarring or discoloration
» up there by repeatedly removing the epidermis so soon after it healing.
» Copper peptides applied for a few weeks might help the skin rebuild in get
» in good shape. Abrading the skin is a rough procedure on the dermis. It
» also probably takes a few days for those same peptides to be “out” of the
» skin before you abrade it. If you just used folligen or tricomin for
» instance and then abraded the skin, the peptides would be present deeper in
» the skin’s layers, probably aiding “repair” signals in response to the
» wound instead of “rebuild” (what we want) signals in the skin. One might
» consider being off the peptides 3-4 days before wounding.
»
»
» Abrasion would have to be very delicately performed for the window to be
» open by day 3 in retrospect. That is probably the very soonest it could
» happen. I imagine days 4-7 or so is when the embyonic window is really
» going to be opening for most of us as we dont have precision abrasion
» instruments at our disposal.

Good points. However, my reason for the inclusion of caffeine is to block the DHT effect. The tannic acid is the EGF inhibitor and the caffeine is the anti-DHT agent. I actually used caffeine the first time around.
You’re probably right about the healing time. I’ll give it a couple of weeks yet before I wound. It is amazing however, how the skin actually recovers. You cannot tell my scalp has been wounded.

34

Debris, you keep bringing up the idea that Folica is gonna want to create an all-new drug rather than use the existing ones, for copyright reasons.

But like I’ve pointed out about this before, I don’t see the logic in that. It’s like saying “Well, we already know that orange juice works. But since we don’t own OJ, we (our tiny little startup company with a handful of employees on a first-name basis with each other, that is) would rather invent & patent our own. We’ll spend a decade and a zillion dollars inventing & certifying some kind of all-new orange juice replacement instead of using what’s on the shelf.”

This overlooks the fact that all their competitors will just go out and use the plain old OJ, take years less total development time to get to market than Folica originally did, and save that zillion dollars while they’re at it.

35

» Debris, you keep bringing up the idea that Folica is gonna want to create
» an all-new drug rather than use the existing ones, for copyright reasons.
»
»
»
» But like I’ve pointed out about this before, I don’t see the logic in
» that. It’s like saying “Well, we already know that orange juice works.
» But since we don’t own OJ, we (our tiny little startup company with a
» handful of employees on a first-name basis with each other, that is) would
» rather invent & patent our own. We’ll spend a decade and a zillion dollars
» inventing & certifying some kind of all-new orange juice replacement
» instead of using what’s on the shelf.”
»
» This overlooks the fact that all their competitors will just go out and
» use the plain old OJ, take years less total development time to get to
» market than Folica originally did, and save that zillion dollars while
» they’re at it.

I guess you are partially right. Their final decision will imho depend on numerous factors, but I believe that the gefinitib path will show up for them to be more obstacled then they hope atm.

It is like that always. ATM they expect to go through trials and satisfy FDA and get NDA. What I see likely to happen will be that

a) genentech will start asking quite a lot for licensing it.

b) FDA will insist on ruling out the lung damage. Though its somehow acceptabe to take risks when you face certain death if you are not treated at all, its absolutely not acceptable for a cosmetic reason to damage someone lungs permanently. So the drug will be topical for sure, and FDA will want to see that it does not harm anyone, the trial wont be small, it will need proper phase II & phase III like trials for sure.

c) this may prove to be similrly expensive to full trials with their own drug candidate especially if licensing fees are taken in account.

c) the licensed gefinitib applied for other reason is somehow disadvatageous to follica, though I see that they may have to do it if that was the only thing they could afford

d) atm it looks like they are studying human scalps only and dont even try gefinitib. It looks to me that they are still deciding what course to take. If their definite plan was to use gefinitib topicaly and license it from genentech, well then they imho would not be wasting this year with some biopsies when gefinitib is already here and available to test. To me it looks like they dont have their drug candidate atm. IF they had they’d be trialing it.

36

» » Debris, you keep bringing up the idea that Folica is gonna want to
» create
» » an all-new drug rather than use the existing ones, for copyright
» reasons.
» »
» »
» »
» » But like I’ve pointed out about this before, I don’t see the logic in
» » that. It’s like saying “Well, we already know that orange juice works.
»
» » But since we don’t own OJ, we (our tiny little startup company with a
» » handful of employees on a first-name basis with each other, that is)
» would
» » rather invent & patent our own. We’ll spend a decade and a zillion
» dollars
» » inventing & certifying some kind of all-new orange juice replacement
» » instead of using what’s on the shelf.”
» »
» » This overlooks the fact that all their competitors will just go out and
» » use the plain old OJ, take years less total development time to get to
» » market than Folica originally did, and save that zillion dollars while
» » they’re at it.
»
» I guess you are partially right. Their final decision will imho depend on
» numerous factors, but I believe that the gefinitib path will show up for
» them to be more obstacled then they hope atm.
»
» It is like that always. ATM they expect to go through trials and satisfy
» FDA and get NDA. What I see likely to happen will be that
»
» a) genentech will start asking quite a lot for licensing it.»
» b) FDA will insist on ruling out the lung damage. Though its somehow
» acceptabe to take risks when you face certain death if you are not treated
» at all, its absolutely not acceptable for a cosmetic reason to damage
» someone lungs permanently. So the drug will be topical for sure, and FDA
» will want to see that it does not harm anyone, the trial wont be small, it
» will need proper phase II & phase III like trials for sure.
»
» c) this may prove to be similrly expensive to full trials with their own
» drug candidate especially if licensing fees are taken in account.
»
» c) the licensed gefinitib applied for other reason is somehow
» disadvatageous to follica, though I see that they may have to do it if that
» was the only thing they could afford
»
» d) atm it looks like they are studying human scalps only and dont even try
» gefinitib. It looks to me that they are still deciding what course to take.
» If their definite plan was to use gefinitib topicaly and license it from
» genentech, well then they imho would not be wasting this year with some
» biopsies when gefinitib is already here and available to test. To me it
» looks like they dont have their drug candidate atm. IF they had they’d be
» trialing it.

Maybe the former CEO of Genentech Kirk Raab who joined Follica’s executive team will be able to help with that.

37

» if your experiment doesn’t pan out and mine didn’t either, I think
» I will try another route if/when I try it again (probably after the new
» year starts).

That is the earliest I can do a round 2 test as well.

» I think I’d keep it as close to the follica experiments as I possibly
» could.

I would like to do this as well, but I am not sure that I can. I will try, though. Hopefully, you or someone else can do a close approximation of the Follica patent.

One other thing to mention is that all of the successful wounds in the patent and the Nature study are pretty small – approximately 1-to-2 centimeters (give or take) in diameter, IIRC. The follices then form in the center of the wound (so, you don’t get hair follicles in the entire area you abrade…maybe the inner 25% of the area you abrade will get follicles.) I wonder if there’s an optimal (or required) wound size for creating new follicles? Maybe a series of small wounds on the scalp would be better than one big one? I don’t know the answers to these questions, but I am just pointing out that our wounds might be bigger than the ones used in Follica’s experiments, so it’s another thing that we’re doing different. BTW, we know there’s a minimum wound size in mice…and the min size gets bigger with age (according to the Nature paper).

38

» » if your experiment doesn’t pan out and mine didn’t either, I think
» » I will try another route if/when I try it again (probably after the new
» » year starts).
»
» That is the earliest I can do a round 2 test as well.
»
» » I think I’d keep it as close to the follica experiments as I possibly
» » could.
»
» I would like to do this as well, but I am not sure that I can. I will try,
» though. Hopefully, you or someone else can do a close approximation of the
» Follica patent.
»
» One other thing to mention is that all of the successful wounds in the
» patent and the Nature study are pretty small – approximately 1-to-2
» centimeters (give or take) in diameter, IIRC. The follices then form in the
» center of the wound (so, you don’t get hair follicles in the entire area
» you abrade…maybe the inner 25% of the area you abrade will get
» follicles.) I wonder if there’s an optimal (or required) wound size for
» creating new follicles? Maybe a series of small wounds on the scalp would
» be better than one big one? I don’t know the answers to these questions,
» but I am just pointing out that our wounds might be bigger than the ones
» used in Follica’s experiments, so it’s another thing that we’re doing
» different. BTW, we know there’s a minimum wound size in mice…and the min
» size gets bigger with age (according to the Nature paper).

dayum…I never thought of this.

To be honest with you, I’ll probably be getting a HT to fill my temples and be done with it. I can fool around with wounding in small spots after that is taken care of whether it be at the front of the hairline or the shoulder or whatever. I will stay on finas and use nizoral a couple of times a week, so the hair that I have isn’t going anywhere in the meantime. I can avoid washing a small patch of a shoulder or a spot below the hairline, or behind the ear, by being careful. Im pretty tired of thinking about hair, period, to be honest with you.

Considering that Follica is trialling at Harvard, Aderans is in phase 2 in the United States, Histogen is researching, and ACELL is “out there” doing whatever, its mathematically in our favor that at least one of these methodologies is going to prove fruitful in “making” more donor hair. Im no longer worried about not having new donor hair 30 years from now-----Im confident that science will overcome that possibility (which is pretty remote for me personally anyway)>

I hope you report if your experiment made some hair for us as Im very interested in your result because Im sure you conducted it well and have the correct tools (getfitinib) for it to work.

39

that s the question. its more about, will there be something out in 10 years or will it need 20 years or more. we cannot expect something in 5 years like you say.

i think it will need at least 10 years that we have a cure. for me the best bet is still intercytex and now even aderans. ICX is in the end of phase II and if their TRC is not dead yet and they will start phase III next year then that may come out in 4 years approximatley. aderans is starting phase II so if intercytex is dead they are my next bet and may come out in 6 years approximatley with a product.

both wont probably be a real cure, though.

i dont put much in follica since they will need 10 years approximatley in my opinion. im happy if we have follica in 10 years or something else. but dont count for anything in the next few years. prepare to wait a long time.

40

The timelines only apply if you’re waiting for a nicely packaged legal product.

Not all of us are.

$15K for a cosmetically visible difference, a year-long ugly duckling growout period, and a permanently scarred-up head . . . all for results half as dense as my original hair?

No thanks. Not if I can possibly find a better way.

HTs are the best option we’ve had for a long time, and I respect what the top HT clinics have accomplished. But in the big picture this option has basically always been a sh*tty one. You still have to be on medication (with real side effects) for life, the guys who need it most are the worst risks to get it, the costs are huge for what it fixes, and the best results are barely half as good as if you just never had the problem. The cost/benefit ratio of HTs is still OBSCENELY bad by the standards of most common cosmetic treatments.