omgIamBald
03.10.2008, 01:23 |
even 5 years for Follica's market lauch looks way to optimistic (Hair Multiplication & Research) |
- Pre clinical (animal studies etc)
- IND granted
- Phase I-III trials
- NDA Granted by FDA
Now, it seems Follica is still doing the pre clinical at Harvard (response of human skin to disruption). Although, they have some investigators and sponsers for IND grants, it will still be another year or 2 to reach to phase I.
even if we assume everything goes perfect (which usually never happens), it will still be 5 years away.
Even 5 years from market launching looks way too optimistic.
And dont forget, when it comes out Bruce Willis is on the first line, not us.
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TAGOHL
08.10.2008, 19:58
@ benji
|
For TAGOHL, next experiment..... |
» To be honest with you, I'll probably be getting a HT to fill my temples
» and be done with it.
Probably not a bad idea. In the short-term, you'll gain a decent amount of hair (and all the benefits that go with it), and by the time the long run comes, one of these up-and-coming treatments should be ready to give you the rest.
» 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.
I will definitely report the results.
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cal
06.10.2008, 18:36
@ helpme007
|
10 or 20 years? |
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.
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helpme007
06.10.2008, 04:14
@ omgIamBald
|
10 or 20 years? |
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.
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benji
05.10.2008, 21:09
@ TAGOHL
|
For TAGOHL, next experiment..... |
» » 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.
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TAGOHL
05.10.2008, 20:37
@ benji
|
For TAGOHL, next experiment..... |
» 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).
TAGOHL is located in [NA] and he is available to meet: NO |
Dogstar
05.10.2008, 16:23
@ debris
|
For TAGOHL, next experiment..... |
» » 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.
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debris
05.10.2008, 15:56
@ cal
|
For TAGOHL, next experiment..... |
» 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.
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cal
05.10.2008, 15:26
@ Baccy
|
For TAGOHL, next experiment..... |
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.
cal is located in [NA] and he is available to meet: NO |
Baccy
05.10.2008, 10:36
@ benji
|
For TAGOHL, next experiment..... |
» » 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.
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benji
05.10.2008, 10:26
@ Baccy
|
For TAGOHL, next experiment..... |
» 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.
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Baccy
05.10.2008, 10:20
@ benji
|
For TAGOHL, next experiment..... |
» 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. [/color]
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.
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TheOne
05.10.2008, 10:19
@ benji
|
For TAGOHL, next experiment..... |
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.
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Baccy
05.10.2008, 10:12
@ Amilcar
|
For TAGOHL, next experiment..... |
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.
Baccy has 1 Personal Journal(s). Click here to view
Baccy is located in [NA] and he is available to meet: NO |
benji
05.10.2008, 10:11
@ Amilcar
|
For TAGOHL, next experiment..... |
» » »
» 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.
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debris
05.10.2008, 10:03
@ TAGOHL
|
Let |
» » 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. 
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.
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Amilcar
05.10.2008, 09:39
@ benji
|
For TAGOHL, next experiment..... |
» 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.
Amilcar is located in [NA] and he is available to meet: NO |
benji
04.10.2008, 23:01
@ TAGOHL
|
For TAGOHL, next experiment..... |
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.
benji is located in [NA] and he is available to meet: NO |
Jakeb
04.10.2008, 21:32
@ TAGOHL
|
Let |
» » 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.
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.
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TAGOHL
04.10.2008, 18:59
@ TAGOHL
|
Let |
» 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.
TAGOHL is located in [NA] and he is available to meet: NO |
TAGOHL
04.10.2008, 18:36
@ debris
|
Let |
»
» 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.
TAGOHL is located in [NA] and he is available to meet: NO |
debris
04.10.2008, 18:22
@ TAGOHL
|
even 5 years for Follica's market lauch looks way to optimistic |
» » 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. 
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.
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TAGOHL
04.10.2008, 16:44
@ TheOne
|
even 5 years for Follica's market lauch looks way to optimistic |
» For example, phase I is a safety trial. The drugs that they are using are
» already approved for safety. Although this doesn't mean follica mis out on
» a safety trial, they can be much shorter, as the previous data is taken
» into account.
I agree, but in my opinion, there won't be a specific trial for safety alone -- instead, they will monitor for side-effects during trials, perform blood tests to detect the level of absorption of the drug when it's applied topically, etc. If their next human trial is abrasion + drugs, then we know this is the case.
I'm not even sure that it makes sense to do a separate trial for just the drug alone -- even if it proves safe, it would be still have to be proven safe with abrasion (since compromised skin significantly increases drug absorption). So, a trial without abrasion doesn't mean it's safe. You need to test them in tandem, which is to say you are testing their whole procedure.
Also, the drug is applied topically for probably at most 7 days. They could do a safety trial in no time at all if they wanted.
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TAGOHL
04.10.2008, 16:23
@ debris
|
even 5 years for Follica's market lauch looks way to optimistic |
» 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.
TAGOHL is located in [NA] and he is available to meet: NO |
debris
04.10.2008, 15:25
(edited by debris, 04.10.2008, 15:53)
@ TheOne
|
even 5 years for Follica's market lauch looks way to optimistic |
I can assure you they will either license gefinitib or create their own from scratch. Considering benefits of their proprietary drug, and likehood that even licensed gefinitib would have to be trialed (topically) to prove safety and exclude the possibility of lung damage, I am pretty sure they will do their own EGF inhibitor.
And the theory of not revealing exact components is ridiculous ... there is no way any medical treatment or drug being sold legally without proper specification of the drug.
Can you name at least one other medical drug thats not listing ingredients? At least a single one? lol.
Sometimes I got a feeling that this forum is full of guys who have been hiding in their homes with caps on their heads 24/7 so that they have lost all their connection with reality.
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TheOne
04.10.2008, 10:08
(edited by TheOne, 04.10.2008, 10:54)
@ debris
|
even 5 years for Follica's market lauch looks way to optimistic |
At this present time, saying follica will take longer than five years because they need to produce a drug from scratch is as naive mjones posts.
Look at the quotes I posted above.
Follica, from day one said they would need trials, what they were saying was that they would be shorter.
For example, phase I is a safety trial. The drugs that they are using are already approved for safety. Although this doesn't mean follica mis out on a safety trial, they can be much shorter, as the previous data is taken into account.
Your arguments for them NEEDING to create a drug from scratch is ridiculous. For example, how do you know that, even using previously approved drugs, it will be so easy to replicate?
Follica may never tell us the exact combination or amount of drugs in their topical.
They may use laser dermabrasion, good luck finding a Dr with the skill to use a medical laser that would be willing to do it to replicate follica.
Their 'kits' will likely be licensed to certain dr's and dermatologists only.
It would take them a decade + to develop a new drug and millions and millions of dollars
In the mean time they would be losing out on money because they could have a product on the market being sold, using existing products.
You have a vivid imagination 
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debris
04.10.2008, 04:36
(edited by debris, 04.10.2008, 06:14)
@ Sceptic
|
A naive optimist? R U KIDDING ME? |
» » » it's better than write useless things like this! Follica use medicines
» » » already approved, so all kind of prevision are false, nobody can know
» » how
» » » they want go on with the work, and how many time this can need...
» »
» » Where is everyone getting all this BS from...they were on TV..the TODAY
» » show...They have something that really works..No other hair loss
» research
» » clinic lab or whatever so far has been on that...So im feeling pretty
» » optimistic they have sometihing good. they said in 2-3 yrs they will
» have
» » something out in themarket...they dont have to do clinical trials cuz
» » everything they have done is safe..iuts just dermabrasion, some
» exisitng
» » medications and lotions and what not....I think it will be a treatment
» not
» » a cure...it will def cover our heads full of hair..Teenage density i
» dont
» » know about that..but if it is that would be AWESOME!!!!! 5 yeard from
» now
» » for a release i think it will be sooner...i think in 2010 we will have
» » something really good out....my opinion..
»
» Debris ... if you read this, this is what you call naive or optimist ?
Naive optimist? No way man. This guy is so much worse.
To be honest, it sounds more like a "lobotomy got wrong" to me.
He saw it on tv (then he says its the first time some hair loss research talk was on tv, which is a clear lie) and thus he made an assumption that in one and half or max 2 years from now on, the treatment will give full coverage (maybe not teenage density, but full coverage), even though trials take usually a decade and most of them are canceled and the product never reaches the market (for safety, financial, or efficiency reasons mostly). Even follica now admits that their goal is trials, but all that that guy needs to think the opposite is his "feeling" and naive assumption that follica can start buying gefinitib (a drug that has some very serious sideeffects, like a permanent & irreversible damage to your lungs) in pharmacies all over the country, package it together with dermaroller & lithium batteries in a pizza box and force every doctor to pay them licensing fees for using this package.
This sounds very rational and logical. Doesn't it?
PS: I apologize for being rant, but could not resist
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debris
04.10.2008, 04:06
(edited by debris, 04.10.2008, 04:31)
@ omgIamBald
|
even 5 years for Follica's market lauch looks way to optimistic |
» - Pre clinical (animal studies etc)
» - IND granted
» - Phase I-III trials
» - NDA Granted by FDA
»
» Now, it seems Follica is still doing the pre clinical at Harvard (response
» of human skin to disruption). Although, they have some investigators and
» sponsers for IND grants, it will still be another year or 2 to reach to
» phase I.
»
» even if we assume everything goes perfect (which usually
» never happens), it will still be 5 years away.
»
» Even 5 years from market launching looks way too optimistic.
»
» And dont forget, when it comes out Bruce Willis is on the first line, not
» us.
Imho its quite obvious (the same way it was obvious many times before about other treatments) that omgIamBald is right. It wont take less then 5 years, and 5 years is pretty damn optimistic.
If they were going to use already approved drugs they would not even bother with IND. But for obvious (commercial) reasons they won't use just existing drugs and thus they won't avoid trials. Their goal is to make huge profits.
Imagine you got full head of hair, and you are a CEO of follica. And you want to make money. If you really manage to get rational thoughts about what to do in such a situation (unafected by your current hairloss, anxiety & desperation), you will get a nice and accurate picture of what is going to happen in Follica. You will come up with something like this:
- in order to be able to make money, they will need a product they can control, and no unauthorised person or company can manufacture.
- this is the way they will be able to set price on that product and make profits and avoid anyone from stealing from their invention.
- a procedure is not such a product, anyone can do a procedure, all you have to do is just not tell anyone. There is no way Follica could stop any doctor doing it if it was just approved drugs. All that would have to happen would be that the doctor would not tell anyone, and if sued (very unlikely because there would be tenths or even hundreds of thousands of such doctors that occasionally would not use Follicas package but quietly without even telling the patient would substitute it with gefinitib and other drugs, and thus would avoid paying Follica the fee), would claim "I have used follicas packages always." or if there was an evidence he actually never used follica's stuff and was selling the procedure in a black market he could always say: "I didn't know that the patient is on the drugs, I did just dermabrassion!!". Trials would take ages, and there would be tons of them.
- a proprietary drug is much better product, its hard to be manufactured by amateurs, and quite hard to be manufactured by professionals. And even if one or few companies managed to manufacture it and started doing so, you have straightforward weapons to protect yourself. You just call customs, they seize the stuff because it will be illegal, and they will shut down any factory thats producing it. Job done.
- this logic was dictating that trials will be needed (even back at times when optimistic trolls here were saying the opposite and all this based on no evidence other then their desperation), the trials will take time, and 5 years is very optimistic time frame for a trial. Especially when they have not even started phase I yet. They are still in preclinicals. I am not aware of any other trial that would get the job done in such a time frame.
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KO
04.10.2008, 00:01
@ mjones
|
even 5 years for Follica's market lauch looks way to optimistic |
» » the thing that sucks is I don't think follica wants to tell anyone their
» » plan. They are increasingly secretive about their work. The only thing
» they
» » will tell the media is when they have raised funds. I'm confused as to
» why
» » they need to tell the media this since they are a privately held
» company...
»
» They are keeping it quiet cuz they have something good and want to be the
» first to bring a real working treatment...i was in Europe last may and they
» were talking about Cotsarelis and his work..It was on TV shows..i mean he
» is a legit scientist and so is his company....i mean he popped out of
» nowhere a few months ago and gave us this news...he might do it again in 2
» years and say guess what guys it will bein the market in 4 months....we are
» common people...we dont know jack about a treatment that will be very
» revolutioanry.....i remember watching a video clip of cotsarelis 7 years
» ago...he was like, there will be no real working treatment until 2010..i
» think he was hinting at soemthing there..and on the today show he say 2-3
» years this follica can reach the market..so thats 2010-2011..hopefuly he
» wont make it longer...i want my hair back!!!
Perhaps I'm mistaken, but I was under the impression that he only discovered this phenomenon one or two years back?
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TheOne
03.10.2008, 13:11
(edited by TheOne, 03.10.2008, 13:29)
@ TAGOHL
|
even 5 years for Follica's market lauch looks way to optimistic |
I agree with some of what you said there, but ive been doing a lot of reading about clinical trials recently to try and gain a better understanding of what they may need to do.
Its highly unlikely that they will be able to miss out phase I altogether, however it will be much faster as the data from the drugs previous aproval is taken into account, but not soley based on this.
While they have done the bulk of the pre clinical work with cotsarelis mouse studies, the current research study is described by Zohar as an investigator-sponsored trial, which is part of the IND process. Which would sudgest that they haven't yet been designated IND status.
Which would leave them unable to test their drugs untill they do so, however no human data is needed for an IND, so they have already applied using pre-clinical data or are close.
I disagree with you when you say it will fall into a grey are because they are marketing a procedure and not drugs, I wont go into too much detail but a drug is a drug regardless of whether it is part of a procedure or not, they will also have to show the safety of the drugs in combination.
It is already pretty much comfirmed that they will need an NDA (Which is FDA approval).
What they haven't told us is how long exactly they intend to spend on each phase.
Your right though, we need to stop speculating and wait for follica to tell us, as nobody can be certain untill then.
They seem pretty confident that they will have a viable product, and want to sell it to us asap.
Zohar says data from the current trial wont be in for at least a year, so I guess we will know more then.
Just for reference, here's pretty much the only information we have regarding time lines;
http://www.helixis.com/news_events/2008/START-UP_Alist.pdf
“Folica, which licensed the technology from the University of Pennsylvania school of medecine, will begin human trials this year. If the results are positive, the company could be positioned to file for an Investigational New Drug Application in two or three years, Zohar says”
http://www.fiercebiotech.com/special-reports/emerging-drug-developer-follica
“Right now their money is funding a small human study which Zohar describes as “more of an investigator-sponsored trial.” And the company has enough money to push the program through proof-of-concept toward an NDA - a path that’s likely to take an accelerated development path that compresses the usual early and mid-stage trials into a 24- to 36-month window. An approval could conceivably be won in four to five years.
“What’s nice about it,” she adds, “is that even though this is based on breakthrough science, 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.”"
http://www.xconomy.com/boston/2008/08/12/new-fundraising-for-hair-raising-follica-takes-in-11-million-for-baldness-treatment-approach/
With the regulatory path relatively clear, Follica’s plan was to use its Series A money to quickly begin a small proof of concept study, involving 15 to 20 patients. Zohar yesterday confirmed that a pilot study is underway but wouldn’t confirm where or give any other details on its timing other than to tacitly stick to the timeline she laid out in January, when she said that final data from the study would not be available for at least a year. “Everything is progressing on track,” she now says. “We are moving as quickly as possible within the constraints of clinically driven medicine.”
http://www.xconomy.com/boston/2008/01/04/gone-today-hair-tomorrow-follica-raises-funds-to-begin-human-trial-of-baldness-treatment/
"A proof of concept study involving 15 to 20 patients (Follica has no shortage of volunteers, as several hundred people sent in e-mails when word of Cotsarelis’s work reached the public) should begin in the next few months. The trial has several phases, however, and Zohar cautions that final data won’t be in for at least a year."
http://stemcellbaldnesscures.com/follica/follica-takes-in-11-million-for-baldness-treatment-approach/
“This financing will enable us to build out the company and move well down the path towards [regulatory] approval,” says Daphne Zohar, managing director of PureTech Ventures (and an Xconomist)."
Dr George Cotsarelis - MSNBC Video
"If everything goes perfectly, it's possible that within a few years we'll have something that is available as a new treatment."
Nancy Snyderman - MSNBC Video
"We are going to have to see human trials which will be in the next year or 2. And I wouldn't be surprised if this uh, didn't turn out to be on the market in the next 3-4 years, maybe even sooner."
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Baccy
03.10.2008, 12:54
@ baldIsMe
|
even 5 years for Follica's market lauch looks way to optimistic |
» the thing that sucks is I don't think follica wants to tell anyone their
» plan. They are increasingly secretive about their work.
From a business point of view, you can't really blame them. There are at least a dozen 'armchair scientists' trying to unlock their secrets.
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Baccy is located in [NA] and he is available to meet: NO |
Sceptic
03.10.2008, 12:18
@ mjones
|
go out and do some sports... |
» » it's better than write useless things like this! Follica use medicines
» » already approved, so all kind of prevision are false, nobody can know
» how
» » they want go on with the work, and how many time this can need...
»
» Where is everyone getting all this BS from...they were on TV..the TODAY
» show...They have something that really works..No other hair loss research
» clinic lab or whatever so far has been on that...So im feeling pretty
» optimistic they have sometihing good. they said in 2-3 yrs they will have
» something out in themarket...they dont have to do clinical trials cuz
» everything they have done is safe..iuts just dermabrasion, some exisitng
» medications and lotions and what not....I think it will be a treatment not
» a cure...it will def cover our heads full of hair..Teenage density i dont
» know about that..but if it is that would be AWESOME!!!!! 5 yeard from now
» for a release i think it will be sooner...i think in 2010 we will have
» something really good out....my opinion..
Debris ... if you read this, this is what you call naive or optimist ?
Sceptic is located in [NA] and he is available to meet: NO |
Max
03.10.2008, 12:07
@ mjones
|
even 5 years for Follica's market lauch looks way to optimistic |
Is it safe,thats Follica workes?
Max is located in [NA] and he is available to meet: NO |
mjones
03.10.2008, 11:50
@ baldIsMe
|
even 5 years for Follica's market lauch looks way to optimistic |
» the thing that sucks is I don't think follica wants to tell anyone their
» plan. They are increasingly secretive about their work. The only thing they
» will tell the media is when they have raised funds. I'm confused as to why
» they need to tell the media this since they are a privately held company...
They are keeping it quiet cuz they have something good and want to be the first to bring a real working treatment...i was in Europe last may and they were talking about Cotsarelis and his work..It was on TV shows..i mean he is a legit scientist and so is his company....i mean he popped out of nowhere a few months ago and gave us this news...he might do it again in 2 years and say guess what guys it will bein the market in 4 months....we are common people...we dont know jack about a treatment that will be very revolutioanry.....i remember watching a video clip of cotsarelis 7 years ago...he was like, there will be no real working treatment until 2010..i think he was hinting at soemthing there..and on the today show he say 2-3 years this follica can reach the market..so thats 2010-2011..hopefuly he wont make it longer...i want my hair back!!!
mjones is located in [NA] and he is available to meet: NO |
baldIsMe
03.10.2008, 11:00
@ TAGOHL
|
even 5 years for Follica's market lauch looks way to optimistic |
the thing that sucks is I don't think follica wants to tell anyone their plan. They are increasingly secretive about their work. The only thing they will tell the media is when they have raised funds. I'm confused as to why they need to tell the media this since they are a privately held company...
baldIsMe is located in [NA] and he is available to meet: NO |
TAGOHL
03.10.2008, 10:49
@ omgIamBald
|
even 5 years for Follica's market lauch looks way to optimistic |
» - Pre clinical (animal studies etc)
Already been done by Follica. Don't forget, Cotsarelis has been working on this for a couple of years already.
» - IND granted
Takes 30 days.
» - Phase I-III trials
They won't have to do Phase 1, which are safety trials. The drugs in question have already been through Phase 1, and have mountains of data on the record. That's the big advantage of using an already-approved drug. I am guessing they will do 1 or 2 trials after the current trial (probably 2).
» - NDA Granted by FDA
For drugs, it takes about 10 months, on average. But it's worth repeating: Follica is not marketing drugs. This is a medical procedure, of which the drug is part of. So, their procedure may fall under a gray area, and it's unclear what kind of approval they need.
» it will still be 5 years away.
The timeline totally depends on the path Follica is going to take, which they haven't divulged yet. A Phase 2 trial would probably last 6 months. Phase 3, 12 months. Approval, 10 months. That's 28 months total (2.5 years), but that's not including the time between trials. Hell, a phase 2 trial wouldn't even start for another 6-12 months. Then there's probably another 6-12 months between the Phase 2 end and the Phase 3 start, and at least several more months after that before they present data to the FDA.
So, you are looking at least 4-5 years if they have to go through all the FDA hoops. Let's wait for Follica to tell us how they are going to proceed.
TAGOHL is located in [NA] and he is available to meet: NO |
coffee
03.10.2008, 10:31
@ mjones
|
go out and do some sports... |
Here's maybe an interesting thought for discussion along these topic lines:
How long are the patents good for and how could this impact the motivation/schedule?
coffee is located in [NA] and he is available to meet: NO |
mjones
03.10.2008, 09:49
@ SPQR
|
go out and do some sports... |
» it's better than write useless things like this! Follica use medicines
» already approved, so all kind of prevision are false, nobody can know how
» they want go on with the work, and how many time this can need...
Where is everyone getting all this BS from...they were on TV..the TODAY show...They have something that really works..No other hair loss research clinic lab or whatever so far has been on that...So im feeling pretty optimistic they have sometihing good. they said in 2-3 yrs they will have something out in themarket...they dont have to do clinical trials cuz everything they have done is safe..iuts just dermabrasion, some exisitng medications and lotions and what not....I think it will be a treatment not a cure...it will def cover our heads full of hair..Teenage density i dont know about that..but if it is that would be AWESOME!!!!! 5 yeard from now for a release i think it will be sooner...i think in 2010 we will have something really good out....my opinion..
mjones is located in [NA] and he is available to meet: NO |
SPQR
03.10.2008, 05:35
@ Dogstar
|
go out and do some sports... |
it's better than write useless things like this! Follica use medicines already approved, so all kind of prevision are false, nobody can know how they want go on with the work, and how many time this can need...
SPQR is located in [NA] and he is available to meet: NO |
Dogstar
03.10.2008, 02:51
@ omgIamBald
|
even 5 years for Follica's market lauch looks way to optimistic |
Thanks for that Nostradamus, This is exactly what we need another post based on guess work.
As far as i know there isn't one person on this message board who works for either Follica or the FDA, Yet there are countless posts rambling on about things that nobody can give a real answer to, Whats the point.
Dogstar is located in [NA] and he is available to meet: NO |
biston
03.10.2008, 01:44
@ omgIamBald
|
even 5 years for Follica's market lauch looks way to optimistic |
topic such this are USELESS, post only FACTS please
biston is located in [NA] and he is available to meet: NO |
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