» » Sorry stevi but as you know i’m french and i not very understand what
» you
» » meaning…
» »
» » So my friends can we believe on intercytex works???
» »
» »
» »
» » Sam LE C-Point magazine.
»
» nan, ca marche pas … Comme te dirons les anglais les résultats ne sont
» pas concluants pour le moment, et de toutes façons personne ne pourra te
» dire ce qu’il en est vraiment (la plupart des lecteurs sont américains et
» lisent ce forum comme seul source d’information concernant icx).
» Actuellement, intercytex a terminé la phase II des tests et fortement
» “éludé” sur les résultats qui étaient un peu décevant, et par ailleurs
» Interctyex a aussi fait savoir qu’il n’étaient pas prêts à financer les
» essais cliniques à venir (ils attendent un possible financement de Bosley,
» avec lesquels ils ont un accord commercial). En gros : c’est pas aussi bon
» qu’espèré initialement et en retard, donc rien n’est perdu mais rien
» vraiment n’est gagné non plus et si ça sort ce n’est pas avant 2012 - 2015
» … c’est une théorie intéressante et “legit”, mais concrètement y’a pas
» grand chose pour l’instant. Finalement, intercytex est une petite boite qui
» n’est pas au top financièrement en ce moment … “The next big thing”
» pourrait être Follica, mais bon tout ça c’est de la recherche donc
» incertain par essence.
»
» voili, voilo
»
» (heu sinon j’ai du mal a croire que tu bosses pour le point ???)
Ya know, this is kind of upsetting. I mean the technology obivously works. Kemp has 66 hairs on his head through this process. Was he lying? I don’t think that’s the case.
Debris has suumed up the situation pretty well overall, but some of us take issue with his assertion that Follica will probably need many more years of human testing.
Follica is using an existing product in a novel way. They are testing topicals for hair usage too, but they seem to think using the meds internally (as they are already FDA-approved) would work fine too. This would not take so long to approve.
What Follica is doing is basically like saying that taking Advil & Mylanta at the same time you dermabrade your skin is gonna work to regrow hair. It’s a different way of doing things, but the approval basics are arguably not very difficult at all. Science has already decided that Advil & Mylanta are safe drugs, and there aren’t currently any notes that getting a scalp injury while taking either one of them is inherently unsafe or something.
IMO the Follica method will either work (soon) or it won’t work at all.
».
»
» Follica is using an existing product in a novel way. they seem to think using the meds
» internally (as they are already FDA-approved) would work fine too. This
» would not take so long to approve.
»
» What Follica is doing is basically like saying that taking Advil & Mylanta
» at the same time you dermabrade your skin is gonna work to regrow hair.
»»
»
» IMO the Follica method will either work (soon) or it won’t work at all.
This is PRECISELY what Im talking about (and Debris just doesnt apparently understand in this context). If you take avodart for 10 days, internal loniten for 3 days, and getifitinib for 10 days INTERNALLY AS THEY ARE MEANT TO BE TAKEN, the FDA aint gonna do shiiiiiit
Basically its down to dermabrasion. The other things in the patent, the anti-histamines, anti-bacterials, even the possible addition of cylcosporin for perhaps five or six days also will not induce the FDA. Follica has already said they dont expect to need FDA approval. Nothing it being injected, all meds can be taken orally. Dermabrasion is already approved, as are all these meds.
But it has to work…it will only take one trial of 20-30 men using all of this stuff to determine if it will work well or not.
IT HAS WORKED IN HUMAN SKIN grafted onto a mouse and MADE HUMAN HAIR, so of course its worthy of being investigated further. If it doesnt work…quite frankly I’d forget about any real hair replacement for at least five more years and probably longer.
Nothing topically has to be used with Follica’s patent
Avodart, loniten, and Getifitinib are all INTERNAL DRUGS, and all three are FDA-approved.
It is no different that (as cal stated) getting dermabrasion on your shoulder while taking Advil and Benadryl internally to ease the pain and prevent inflammation. All these drugs are FDA approved.
It will only take one test to see if it actually works.
FOLLICA GREW HAIR ON HUMAN SKIN GRAFTED ONTO A MOUSE>>>>>>>>>>>>>>>HUMAN HAIR GREW. That alone is reason for further study.
It will either work or it wont, period. I think if the trial (singular) fails, then there is no real reason to investigate it further. I also think if Follica fails, then its best to forget any real hair multiplication for at least five years…as in this HM board will be a waste of time for the next five years because there is nothing in the pipeline that is that close. In other words, you all better hope that Follica’s trial is successful when they start it. Waiting for cloning to come out of the Indian clinics, Phoenixbio, Intercytex (if they actually get someone to buy their technology) or Aderans is waiting on a mere hope----ICX and Aderans have been at this for several years now and Im inclined to believe that every month that passes with no winning protocol makes it look as if cell injections of cultured donor-area follicle cells just isn’t going to work very well, period. At some point, they will tire of spending money on this also—even at Aderans.
It may have been approved for other use, but not for growing new organs de novo. It is supposed to grow new tissue. This sounds like possible cancer trigger. FDA will raise that for sure.
I mean anything that grows hair de novo will have it tough with FDA. It’s like saying hey I can grow new kidney for you and all I need is this and that and cut you there and chuck the stuff in. All the stuff I use is old I just use it in a new way so it grows organs!! Imagine that. and imagine FDA saying cool, start selling it guys!!
If it was old stuff that was used in an old way for a new thing, then there is no problem with that because, the old stuff and the old way have already been tested so FDA knows its safe.
Unfortunately it is the fact that they want to use it in a way that has never been tested that will make FDA to ask for trials. All the buzz about skipping trials is wishful thinking of desperate minds. It has proven to be with ICX before and will prove even now.
All that means that if some miracle does not come out of blue (and it never does), we can be stuck bald easily for the next 10-15 years. Ill be fcking 44 in 15 years from now on.
They are approved for internal use not for chucking it into wounds and making it to grow new tissue and organs and (possibly god please no, cancerous cells!!!)
Old stuff never needs approval only if it is used in the way it has been tested (even though it now was going to be used for a new purpose).
If it was old stuff that was used in an old way for a new thing, then there is no problem with that because, the old stuff and the old way have already been tested so FDA knows its safe.
They do not use the drugs in the doses tested before, they do not use them internally, they chuck them into the wound and thus they bypass many important mechanisms in your body and potentially are much more concentrated at the spot.
It is the fact that they want to use it in a way that has never been tested (and that is supposed to grow new organs in your skin, imagine that!) that will make FDA to ask for trials. All the buzz about skipping trials is wishful thinking of desperate minds. It has proven to be with ICX before and will prove even now.
There is absolutely no logical justification for FDA having it to bypass safety trials (these are all 3 trials guys, not just the first one, most of drugs are stopped in phase II or III due to safety reasons, not in phase I).
I agree that it is not so unlikely that it won’t work at all in humans and thus no 3 trials will ever happen.
» It may have been approved for other use, but not for growing new organs de
» novo. It is supposed to grow new tissue. This sounds like possible cancer
» trigger. FDA will raise that for sure.
»
» I mean anything that grows hair de novo will have it tough with FDA. It’s
» like saying hey I can grow new kidney for you and all I need is this and
» that and cut you there and chuck the stuff in. All the stuff I use is old I
» just use it in a new way so it grows organs!! Imagine that. and imagine FDA
» saying cool, start selling it guys!!
»
» If it was old stuff that was used in an old way for a new thing, then
» there is no problem with that because, the old stuff and the old way have
» already been tested so FDA knows its safe.
»
» Unfortunately it is the fact that they want to use it in a way that has
» never been tested that will make FDA to ask for trials. All the buzz about
» skipping trials is wishful thinking of desperate minds. It has proven to be
» with ICX before and will prove even now.
»
» All that means that if some miracle does not come out of blue (and it
» never does), we can be stuck bald easily for the next 10-15 years. Ill be
» fcking 44 in 15 years from now on.
i think you are right, debris. past has shown that its not good to be overly optimistic with hairloss research. so many people thought intercytex could bring out TRC in 2008/2009 or at least 2010. now it looks more like 2013.
i will be 39 in 15 years. umm. well, maybe at this time there is still nothing out. lets hope at least some new med comes out for hairloss like neosh101 or this other discussed med. thats maybe our best bet.
using drugs off-label INTERNALLY is done all the time
the FDA has recently even RELAXED rules to make this even more prevalent
Getting on getifitinib, avodart, and loniten for seven or eight DAYS (which you can do right now if you are willing to pay for the very expensive getifitinib) isn’t something the FDA could control anyway.
Dermabrasion is currently legal everywhere. There is really nothing the FDA can do anyway as these drugs are available online
But none of it will matter if it doesn’t work, thats why I want trials to commence
»»
» i think you are right, debris. past has shown that its not good to be
» overly optimistic with hairloss research. so many people thought intercytex
» could bring out TRC in 2008/2009 or at least 2010. now it looks more like
» 2013. Helpme ICX is the entity that was saying "possible small-scale commercialization in 2008, THEY WERE THE ONES MISLEADING AND LYING ABOUT HOW FAR ALONG THEY WERE. IF we had all seen pics of their trialees, we’d have known that weren’t very close…WE WERENT FOOLED, WE WERE MISLEAD about how close they were by them.
»
» i will be 39 in 15 years. umm. well, maybe at this time there is still
» nothing out. lets hope at least some new med comes out for hairloss like
» neosh101 or this other discussed med. thats maybe our best bet.
I’ll make it plain for you Helpme, if Follica’s trials fail…I’d buzz my head and forget it if I were you…because it will be a long while if they fail, probably closer to ten years than five.
» They are approved for internal use not for chucking it into wounds and
» making it to grow new tissue and organs and (possibly god please no,
» cancerous cells!!!)
»
» Old stuff never needs approval only if it is used in the way it has been
» tested (even though it now was going to be used for a new purpose).
»
» If it was old stuff that was used in an old way for a new thing, then
» there is no problem with that because, the old stuff and the old way have
» already been tested so FDA knows its safe.
»
» They do not use the drugs in the doses tested before, they do not use them
» internally, they chuck them into the wound and thus they bypass many
» important mechanisms in your body and potentially are much more
» concentrated at the spot.
If a drug is approved for you to ingest then there are certainly no major safety concerns about topical application.
» It is the fact that they want to use it in a way that has never been
» tested (and that is supposed to grow new organs in your skin, imagine
minox grows new organs and is sold over the counter. This is a proocedure to grow new hair follicles. You can try to put it in as alarmist language as you want but tat the end of the day its a cosmetic procedure with probably much less risk than 90% of other cosmetic procedures performed every day around the world.
» that!) that will make FDA to ask for trials. All the buzz about skipping
» trials is wishful thinking of desperate minds. It has proven to be with ICX
» before and will prove even now.
»
» There is absolutely no logical justification for FDA having it to bypass
» safety trials (these are all 3 trials guys, not just the first one, most of
» drugs are stopped in phase II or III due to safety reasons, not in phase
» I).
I dont even see that as that important. If Follica came out and said this works files a patent and the FDA did say hold on then you would have a million guys doing their own backyard version of the procedure. Getting the materials and the basic effect is not especially difficult. Follica are interested in optimising the process apart from seeing how well it works if at all specifically on bald/balding human scalp. If it does work well then there is nothing incredibly exotic about the method thusfar that would stop you from achieveing something yourself. You might not go from a cueball to…The Fonz but something could be done.
» I agree that it is not so unlikely that it won’t work at all in humans and
» thus no 3 trials will ever happen.
It almost certainly works in humans. It works in human skin after all. The only questions are to what degree if any the balding scalp inhibits this process, how well it works (is the regrown hair terminal, dense etc), and how long does regrown hair last.
hh
» »»
» » i think you are right, debris. past has shown that its not good to be
» » overly optimistic with hairloss research. so many people thought
» intercytex
» » could bring out TRC in 2008/2009 or at least 2010. now it looks more
» like
» » 2013. Helpme ICX is the entity that was saying "possible
» small-scale commercialization in 2008, THEY WERE THE ONES MISLEADING AND
» LYING ABOUT HOW FAR ALONG THEY WERE. IF we had all seen pics of their
» trialees, we’d have known that weren’t very close…WE
» WERENT FOOLED, WE WERE MISLEAD about how close they were by them.
»
i dont think we were mislead. they said the truth. they were thinking about a small-scale commercialization in 2008, just thinking. and they said the earliest TRC could come out was 2010. its still true…
» »
» » i will be 39 in 15 years. umm. well, maybe at this time there is still
» » nothing out. lets hope at least some new med comes out for hairloss
» like
» » neosh101 or this other discussed med. thats maybe our best bet.
»
» I’ll make it plain for you Helpme, if Follica’s trials
» fail…I’d buzz my head and forget it if I were
» you…because it will be a long while if they fail, probably
» closer to ten years than five.
you’ll have to buzz your head too ;). you are right with that, if follica fails it will probably be more than 5 years until something comes along.
As far as I understand it they apply it to the wound. It’s wounding (may be a bit deeper then dermabrassion) + application of topical drug coctail. isn’t it?
If it was dermabrassion and take a pill then well possibly you are right. And you are definately right about this discussion being pointless in a quite probable case that it would not work at all.
»
» If a drug is approved for you to ingest then there are certainly no major
» safety concerns about topical application.
»
Here is where I don’t agree. if it has been aproved for ingestion, and never grew new organs, and now it was being to be used topically into a wound, to grow completely new little tiny organs de novo (which has never been echeived nor even tried before), then it will raise safety concerns related to unwanted growth for sure.
» minox grows new organs and is sold over the counter.
It does not, it revives existing hair follicles.
» This is a proocedure to grow new hair follicles. You can try to put it in as » alarmist language as you want but tat the end of the day its a cosmetic
» procedure with probably much less risk than 90% of other cosmetic procedures
» performed every day around the world.
This is not true as well. Follica procedure is the first one that grows completely new hair follicles out of nowhere. All existing ones revive already existing but miniaturized follicles.
» It almost certainly works in humans. It works in human skin after all.
It does not, it worked in human skin that was completely healthy without fibrosis and scarring that was planted on a back of a mouse that has no immune system so it does not reject the tissue.
For example if you take that dead follicle of yours and plant it into such a mouse, it revives itself completely on its own without any drugs. This shows how important difference the human immune system presents.
» Here is where I don’t agree. if it has been aproved for ingestion,
Doesn’t matter. Docs and clinics are free to use any approved drug off-label. There is absolutely a ton of precedent supporting this. Furthermore, the newly drafted FDA guidelines about to be adopted further reduces the FDA’s oversight of off-label usage of drugs.
Applying a couple of approved drugs to your skin for 10 days will not require any approval. By the time you even apply the drugs (several days after wounding) the skin will be mostly healed by then, anyway.
» It may have been approved for other use, but not for growing new organs
It doesn’t matter. PHYSICIANS CAN USE DRUGS FOR CONDITIONS UNRELATED TO ITS APPROVED USE. It’s the law of the land.
It is supposed to grow new tissue. This sounds like possible cancer
» trigger.
The main drug in Follic’s topical actually kills cancer. That’s what it’s approved for – to destroy cancer cells.
» I mean anything that grows hair de novo will have it tough with FDA.
I imagine the company knows better than anyone what is required. Do you think they didn’t research this or something? Don’t you think this is issue #1? If they say no approval is necessary, I am inclined to believe to them, and I am inclined to believe they researched it appropriately (i.e., they ran it by the FDA).
debris is like the Anti-Christ of Nathan & TheGame…dude just relax, you’re being overly pessimistic about Follica.
I recently had a discussion with someone who works at FDA and evaluates cancer drugs i.e. chemical composition, trial data etc. Although, we didn’t have any specific discussion about Follica, he did say that the trial requirements for each and every procedure/drug is different i.e. length of trials, people required to demonstrate safety & efficacy and number of trials. Like for cancer drug if there is a drug that has demonstrated good safety in phase-I and good efficacy in phase-II it can be marketed after phase-II.
As of Follica, the primary concern is safety, I highly doubt follica is stupid enough to just peel way skin on few guys and put them on drugs. The reason they haven’t started the trials yet is because they are still going over their protocol. And they’d probably also use the upcoming trial to satisfy FDA phase-I requirements. Depending on how that goes, the trials may be very short or the requirements quite lenient.
I yet to have to see a precedent for applying drug into a wound with an intention to trigger neogenesis and grow new organs & tissue completely out of nothing. And follica as far as I know claim new follicles, not reviving or increasing thickness of existing ones. They say that this wounding + drug creates new follicles where nothing has been before. I seriously doubt that FDA will just tolerate that without trials.
Wishful thinking proved to be wrong many times before.
If I’m being to sceptic and thus wrong on this than it will be for the first time I was.
» » Here is where I don’t agree. if it has been aproved for ingestion,
»
» Doesn’t matter. Docs and clinics are free to use any approved drug
» off-label. There is absolutely a ton of precedent supporting this.
» Furthermore, the newly drafted FDA guidelines about to be adopted further
» reduces the FDA’s oversight of off-label usage of drugs.
»
» Applying a couple of approved drugs to your skin for 10 days will not
» require any approval. By the time you even apply the drugs (several days
» after wounding) the skin will be mostly healed by then, anyway.
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