Spanish Dude
21.03.2008, 21:48
(edited by Spanish Dude, 21.03.2008, 21:53) |
Reconsidering my position about ICX. Going positive now. (Hair Multiplication & Research) |
Reading Monty's posts, I have found this document about ICX which is quite interesting to see things in perspective:
http://www.intercytex.com/icx/investors/rep/otherdocs/2006-08-03/at_aim.pdf
page 41, onwards.
Maybe the main problem is money after all. Lack of money.
The document, tells ICX's roadmap:
-in phase II, they were going to try 3 different formulations.
-Then, If some of the 3 formulations worked, they would jump to Phase III
using the best formulation.
-If none of them worked, then they would expand phase II to try new formulations.
So they covered the possibility of failure for these 3 formulations, and they planned to try more formulations.
So even if all 3 formulations failed, they didn't plan to stop the project!!!
Why are they stopping now, even if the preestimulation seems promising?? Well, the only explanation seems that there is a severe lack of money.
But if the problem is the lack of money, and the preestimulation is working ok, then why are they hiding the number of hairs?
I don't know.
They also say, very important,:
QUOTE:
>>>>
The proposed Phase II study strategy seems appropriate given the uncertainty about optimal formulation, the need to generate safety data for the US IND, limitations regarding number of injections possible prior to scale up and the need to find the optimal clinical setting. The timings for the proposed Phase II study seem reasonable given that this is a highly motivated patient population, though the study(ies) will require longer if further formulations need to be evaluated or if further safety data is required for the IND.
Budget estimates to mid-2007 for the first 20 patients in the THATCH II trial
(£500k) are adequate. If recruitment of further patients is required for THATCH II there will be additional costs. No budget is yet available for the pivotal Phase III trial.
Small studies have been carried out to date in model systems with human female DPs and it is too early to say what their long term fate will be.
<<<<
So this document states that ICX had budget only for 20 trialists in phase II
(500k pounds).
There was no budget for Phase III yet. And apparently no budget for an expanded phase II.
But in spite of this, they say that they had plans to set up a manufacturing facility in USA for 2009, ready for product launch.
QUOTE:
>>>
Currently the product is manufactured at the Group’s Manchester facility. In the USA a anufacturing facility will be set up at the same location as that for ICX-PRO; this is lanned to become operational in 2009 in time for product launch.
<<<
So it seems clear that they initially planned to keep investing money in the project beyond phase II.
It seems that now, they can't afford these projects.
I would say that it is fundamentally by lack of money.
Apparently, they have money but just for the skin products.
Well, if my new guessings are right, maybe we are lucky if they find someone to pay the bills.
But of course, this is a big setback.
Spanish Dude is located in [NA] and he is available to meet: NO |
ssssss
21.03.2008, 22:24
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
y spend money on phase iii if not needed. they didnt do phase iii on vavelta, they didnt even complete full phase ii on vavelta and still launched it. they dont want to do phase iii on ICX SKN, now they dont want to do it on TRC so 3 of their 4 products will not have phase iii
they want sell trc now because they have all data and they can make money, after all they r doing commercial work for a reason
ssssss is located in [NA] and he is available to meet: NO |
TheOne
21.03.2008, 22:26
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
» Reading Monty's posts, I have found this document about ICX which is quite
» interesting to see things in perspective:
»
» http://www.intercytex.com/icx/investors/rep/otherdocs/2006-08-03/at_aim.pdf
»
» page 41, onwards.
»
» Maybe the main problem is money after all. Lack of money.
» The document, tells ICX's roadmap:
»
» -in phase II, they were going to try 3 different formulations.
»
» -Then, If some of the 3 formulations worked, they would jump to Phase III
» using the best formulation.
» -If none of them worked, then they would expand phase II to try new
» formulations.
»
» So they covered the possibility of failure for these 3 formulations, and
» they planned to try more formulations.
»
» So even if all 3 formulations failed, they didn't plan to stop the
» project!!!
» Why are they stopping now, even if the preestimulation seems promising??
» Well, the only explanation seems that there is a severe lack of money.
»
» But if the problem is the lack of money, and the preestimulation is
» working ok, then why are they hiding the number of hairs?
» I don't know.
»
» They also say, very important,:
» QUOTE:
» >>>>
» The proposed Phase II study strategy seems appropriate given the
» uncertainty about optimal formulation, the need to generate safety data
» for the US IND, limitations regarding number of injections possible prior
» to scale up and the need to find the optimal clinical setting. The timings
» for the proposed Phase II study seem reasonable given that this is a highly
» motivated patient population, though the study(ies) will require longer if
» further formulations need to be evaluated or if further safety data is
» required for the IND.
» Budget estimates to mid-2007 for the first 20 patients in the THATCH II
» trial
» (£500k) are adequate. If recruitment of further patients is required for
» THATCH II there will be additional costs. No budget is yet available for
» the pivotal Phase III trial.
» Small studies have been carried out to date in model systems with human
» female DPs and it is too early to say what their long term fate will be.
» <<<<
»
» So this document states that ICX had budget only for 20 trialists in phase
» II
» (500k pounds).
» There was no budget for Phase III yet. And apparently no budget for an
» expanded phase II.
»
» But in spite of this, they say that they had plans to set up a
» manufacturing facility in USA for 2009, ready for product launch.
»
» QUOTE:
» >>>
» Currently the product is manufactured at the Group’s Manchester facility.
» In the USA a anufacturing facility will be set up at the same location as
» that for ICX-PRO; this is lanned to become operational in 2009 in time for
» product launch.
» <<<
»
» So it seems clear that they initially planned to keep investing money in
» the project beyond phase II.
»
» It seems that now, they can't afford these projects.
» I would say that it is fundamentally by lack of money.
»
» Apparently, they have money but just for the skin products.
»
» Well, if my new guessings are right, maybe we are lucky and it is possible
» that TRC is not dead after all. If they find someone to pay the bills.
» But of course, this is a big setback.
Wow that was a very informative read.
It was written some time ago though so things could have changed since then.
"At launch the
product will be positioned as a ‘filler’ in the early stages of hair loss, or for use in
combination with follicular transplantation in males, to provide a hair thickening effect.
Longer term plans include use as a stand alone treatment in younger males and females."
"Intercytex plans to launch the product initially for use in combination with follicular
transplantation in males, to provide a thickening effect. This will fit with its commercial
strategy of partnering with a company already active in the follicular transplantation
business e.g. Bosley Medical. The ‘hair thickening’ usage of ICX-TRC will be expanded
as a stand alone treatment for younger males with early male pattern baldness for whom
follicular transplantation would not be recommended. In this sector, additional revenues
could be derived from storage of cultures for future implantation. The ‘‘hair thickening’’
concept should also play well in the female market where all-over hair thinning is the
issue of concern."
TheOne is located in [NA] and he is available to meet: NO |
Spanish Dude
21.03.2008, 22:45
@ TheOne
|
Reconsidering my position about ICX. Going positive now. |
Yes, and regarding hair direction look at this part:
>>
In the longer term Intercytex is evaluating whether the optimal setting for a pivotal
clinical study, and hence first marketing approval, is as a ‘filler’ in the early stages of hair
loss or as as an adjunct to transplantation. This seems reasonable given the absence of
information on the cosmetic acceptability of the hair produced.
<<
So they are saying that they don't know if the direction will be correct, and that is why they are considering the worst-case scenario, and that is why they will only use it as "thickener".
But also note that in this document they already mention that in phase I, 5/7 regrew new hair.
So they know how this new hair looks, and if the direction is good or not.
Then, if they are planning to use it as thickener, its because the initial results have bad direction, and they need to solve it. That is why they are considering to use it as thickener only at the beginning.
This document is very useful, although it is a bit old.
Spanish Dude is located in [NA] and he is available to meet: NO |
Spanish Dude
21.03.2008, 22:48
@ ssssss
|
Reconsidering my position about ICX. Going positive now. |
» y spend money on phase iii if not needed. they didnt do phase iii on
» vavelta, they didnt even complete full phase ii on vavelta and still
» launched it. they dont want to do phase iii on ICX SKN, now they dont
» want to do it on TRC so 3 of their 4 products will not have phase iii
»
» they want sell trc now because they have all data and they can make money,
» after all they r doing commercial work for a reason
no, the situation with Vavelta is different.
They are doing more phase II trials with Vavelta, even if they have "launched". This launch is not a definitive launch. This is only small-scale. But they keep doing trials.
In the case of TRC, unless they find new money, everything will stop.
Spanish Dude is located in [NA] and he is available to meet: NO |
ssssss
21.03.2008, 23:32
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
well y waste more money on carrying completing phase ii clinical amc commercial work, y not end it now ? if they have to do clinical work then y do commercial work with it if there is nothing to commercialise
ssssss is located in [NA] and he is available to meet: NO |
Spanish Dude
22.03.2008, 00:02
@ ssssss
|
Reconsidering my position about ICX. Going positive now. |
» well y waste more money on carrying completing phase ii clinical amc
» commercial work, y not end it now ? if they have to do clinical work then
» y do commercial work with it if there is nothing to commercialise
what?? I don't understand anything.
Spanish Dude is located in [NA] and he is available to meet: NO |
ssssss
22.03.2008, 00:44
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
another website is saying they r looking 4 some1 to do the procedures
ssssss is located in [NA] and he is available to meet: NO |
Spanish Dude
22.03.2008, 00:59
@ ssssss
|
Reconsidering my position about ICX. Going positive now. |
» another website is saying they r looking 4 some1 to do the procedures.
We have talked about all this in this forum. Read all the posts and you have all the info available.
They have no money to keep going. That is why they need a partner.
They need more research. TRC is not ready for market yet as Vavelta is.
Even unregulated, TRC would not be ready, and they have no money left.
this is what we can deduce from the very limited info.
Spanish Dude is located in [NA] and he is available to meet: NO |
HanginInThere
Somewhere,
22.03.2008, 04:56
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
» » another website is saying they r looking 4 some1 to do the procedures.
»
» We have talked about all this in this forum. Read all the posts and you
» have all the info available.
»
» They have no money to keep going. That is why they need a partner.
» They need more research. TRC is not ready for market yet as Vavelta is.
» Even unregulated, TRC would not be ready, and they have no money left.
»
» this is what we can deduce from the very limited info.
What i dont understand is this people saying that phase III costs 100 million for the testing. How in the world is it possible even if it was 500 test subjects, for a clinical trial to cost 100 million dollars? I understand they have to pay staff salaries etc, but lets say you have 100 scientists at 50k per year, for one year is 5 million dollars, and you know they do not have that many scientists, well maybe they do. I still cant see where they come up with 100 million dollars
HanginInThere is located in SOMEWHERE and he is available to meet: NO ---
Hangin Regimen...........
Maxi Hair by Country Life 2/day
Kal Amino Max ..Chelated Multi Mineral..2/day
DHT blockers (daily intake)
Saw Palmetto, 320mg Standardized
Pygeum 500mg
Nettles 500mg
Beta Sitosterol 125mg
2% Nizoral Cream Topically Nightly,,,after Shampoo |
Spanish Dude
22.03.2008, 10:25
@ HanginInThere
|
Reconsidering my position about ICX. Going positive now. |
» What i dont understand is this people saying that phase III costs 100
» million for the testing. How in the world is it possible even if it was
» 500 test subjects, for a clinical trial to cost 100 million dollars? I
» understand they have to pay staff salaries etc, but lets say you have 100
» scientists at 50k per year, for one year is 5 million dollars, and you
» know they do not have that many scientists, well maybe they do. I still
» cant see where they come up with 100 million dollars
the pdf says:
>>
Budget estimates to mid-2007 for the first 20 patients in the THATCH II trial
(£500k) are adequate.
<<
So this is 1 million USD for 20 test subjects in Phase II.
This would be 25 million USD for 500 subjects.
But probably PhaseIII is more expensive per trialist than PhaseII.
Spanish Dude is located in [NA] and he is available to meet: NO |
Spanish Dude
22.03.2008, 10:35
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
» the pdf says:
» >>
» Budget estimates to mid-2007 for the first 20 patients in the THATCH II
» trial
» (£500k) are adequate.
» <<
»
» So this is 1 million USD for 20 test subjects in Phase II.
» This would be 25 million USD for 500 subjects.
» But probably PhaseIII is more expensive per trialist than PhaseII.
And I think in Phase III, the trialists will be studied for a much longer period.
Then cost would easily reach the 100 million USD you said.
Spanish Dude is located in [NA] and he is available to meet: NO |
HanginInThere
Somewhere,
22.03.2008, 10:56
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
» » the pdf says:
» » >>
» » Budget estimates to mid-2007 for the first 20 patients in the THATCH II
» » trial
» » (£500k) are adequate.
» » <<
» »
» » So this is 1 million USD for 20 test subjects in Phase II.
» » This would be 25 million USD for 500 subjects.
» » But probably PhaseIII is more expensive per trialist than PhaseII.
»
» And I think in Phase III, the trialists will be studied for a much longer
» period.
» Then cost would easily reach the 100 million USD you said.
as far as I read phase 2 only had less than 20 test subjects and a lot of them dropped out on top of that. i seriously doubt that phase 3 would have 500 test subjects
I still would like to see breakdown on where they spend 100 million dollars thats A HELL OF A LOT OF MONEY for a study
HanginInThere is located in SOMEWHERE and he is available to meet: NO ---
Hangin Regimen...........
Maxi Hair by Country Life 2/day
Kal Amino Max ..Chelated Multi Mineral..2/day
DHT blockers (daily intake)
Saw Palmetto, 320mg Standardized
Pygeum 500mg
Nettles 500mg
Beta Sitosterol 125mg
2% Nizoral Cream Topically Nightly,,,after Shampoo |
Spanish Dude
22.03.2008, 11:44
@ HanginInThere
|
Reconsidering my position about ICX. Going positive now. |
» as far as I read phase 2 only had less than 20 test subjects and a lot of
» them dropped out on top of that. i seriously doubt that phase 3 would have
» 500 test subjects
»
» I still would like to see breakdown on where they spend 100 million
» dollars thats A HELL OF A LOT OF MONEY for a study
phase2 has treated 19 subjects.
1 has been lost to follow up.
5+5 have been already evaluated for several weeks
8 are going to be evaluated next.
I think that lack of money is forcing ICX to use reduced cohorts.
I also doubt that phase III will have as much as 500 subjects, but if ICX gets money, maybe the number of trialists will be a decent one.
btw, who said phase III will cost 100million USD?
Spanish Dude is located in [NA] and he is available to meet: NO |
HanginInThere
Somewhere,
22.03.2008, 12:48
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
» » as far as I read phase 2 only had less than 20 test subjects and a lot
» of
» » them dropped out on top of that. i seriously doubt that phase 3 would
» have
» » 500 test subjects
» »
» » I still would like to see breakdown on where they spend 100 million
» » dollars thats A HELL OF A LOT OF MONEY for a study
»
» phase2 has treated 19 subjects.
» 1 has been lost to follow up.
» 5+5 have been already evaluated for several weeks
» 8 are going to be evaluated next.
»
» I think that lack of money is forcing ICX to use reduced cohorts.
»
» I also doubt that phase III will have as much as 500 subjects, but if ICX
» gets money, maybe the number of trialists will be a decent one.
»
»
» btw, who said phase III will cost 100million USD?
i saw that number thrown around not sure by whom
if its not accurate what do you think the amount would be
HanginInThere is located in SOMEWHERE and he is available to meet: NO ---
Hangin Regimen...........
Maxi Hair by Country Life 2/day
Kal Amino Max ..Chelated Multi Mineral..2/day
DHT blockers (daily intake)
Saw Palmetto, 320mg Standardized
Pygeum 500mg
Nettles 500mg
Beta Sitosterol 125mg
2% Nizoral Cream Topically Nightly,,,after Shampoo |
benji
22.03.2008, 12:56
(edited by benji, 22.03.2008, 13:02)
@ Spanish Dude
|
10 million dollar phase 3 FDA trial===on the cheap |
Neuren, a new drug, had a mere 10 million dollars budgeted for its phase 3 FDA trial http://www.scoop.co.nz/stories/SC0701/S00054.htm
".......Neuren has engaged a US-based, international contract research organisation to manage the global trial of 520 patients which will be carried out in the US, Australia and New Zealand. This Phase 3 trial is double-blind, multi-centred, placebo controlled and is based on endpoints that have been well-established in previous FDA-approved studies using validated measurement techniques. The trial is estimated to take 18 months.
The Phase 3 trial is budgeted to cost Neuren A$10 million, which is substantially less than many other Phase 3 trial"
Ive looked at the Motley Fools website and they pointed out that some drugs have taken 350 million dollars to get through the entire three phases of FDA trials and to be approved for sale. Sometimes FDA phase 3 trials cost over 100 million. Ive read that in the past.
However, chances are slim something like a few injections on your noggin' would make it that expensive
Here is why Im not so enthusiastic however..........SCID mice.
Aderans and ICX have had SEVERAL YEARS to graft human skin on SCID mice and practice HM. There is no telling how many little lab animals they have shot up in this way, and if they haven't they are fools as they are the best test method we have to "practice" an indication like this before moving to human beings, which is expensive and requires a hell of alot more precaution. How many lab mice have ICX and Aderans shot up? I'd bet its a bunch by now. They already had their favorite mixes before phase two in all likelihood, one gets those ducks in a row before phase 2. You can test on these mice before PHASE 1.
My idea, which I still think is the best, is to do the HM protocol that makes the most hair................and inject the "hair seeds" (Ken Washenik's one time description of them) into a man's thigh after he has had hair removal there. Any hairs that grow would obviously be HM hairs. An FUE doc would then transplant the hair growing from the thigh to the head as a fully differentiated hair. If he got no growth down there, he wouldn't be getting his head shot up a bazillion times with needles for nothing. I'd do this until better results were had in HM testing. They could start making money in the NOW this way. A man would merely pay an increased amount per graft (probably more than 10 bucks) instead of 5 or 6 dollars per graft. One BHT doc, Umar, was doing BHT's for 5 bucks in the past.Its the only way to have a hair surgery in the NOW that would put MORE hair on your head than what you had before. If a man got both his upper thights shot up with HM, and moderate hair growth ensued (head hair wont grow long in length on the body), he could have a few thousand real differentiated hairs moved to his head in this way. Most men on finasteride dont need 60,000 hairs, just 10,000 or so. In conjunction with a regular transplant, this would be "enough" to meet most mens needs up there.
If one is cueball bald with only 10,000 hairs on their entire head.........they'd be needing too much to do in this way.
Waiting for conventional HM to really work good in human heads is obviously going to be a few years away in my opinion based on their phase two results. This is a tough nut to crack apparently. If Aderans buys what ICX has after September.........it still might be several years, as in five or more as Bosley would be distributing it and they'd have to get with the FDA and see if the FDA would accept the phase 2 trials that ICX did before having a phase 3 and then the review process EVEN IF IT WORKED GOOD ENOUGH TO GO FORWARD WITH........ Aderans will have money for this if they think they have a winner.
benji is located in [NA] and he is available to meet: NO |
Spanish Dude
22.03.2008, 13:25
@ benji
|
10 million dollar phase 3 FDA trial===on the cheap |
okay, Benji, then lets assume 100 million USD for phase III with a decent set of trialists.
Regarding your suggested method of preseeding the upper thigh, could be a solution. Although maybe the characteristics of the hair are altered. Maybe it is better to put the seeds on the scalp, and then replant the hairs with the correct direction.
They could even use mice to pregrow the hairs, although this is an unpleasant idea.
For me it is clear that the direction problem is not yet solved, and maybe that is why ICX lately mentioned about growing the hairs outside the body and then planting on the scalp.
If the direction is bad as I suspect, I don't see how these hairs can be used as "filler", unless the hairs are replanted. If the new hairs are chaotic, you will have a strange mixture of correct+chaotic hairs in the head, and the result will be pretty bad.
Also, lets remember that ARI has researched a lot in scaffolds, so they could join ICX and reach a viable solution.
Spanish Dude is located in [NA] and he is available to meet: NO |
Spanish Dude
22.03.2008, 13:26
@ HanginInThere
|
Reconsidering my position about ICX. Going positive now. |
ok, 100 million USD then. Benji has convinced me.
Spanish Dude is located in [NA] and he is available to meet: NO |
benji
22.03.2008, 14:26
@ Spanish Dude
|
10 million dollar phase 3 FDA trial===on the cheap |
There is alot wrong in your post here»
» Regarding your suggested method of preseeding the upper thigh, could be a
» solution. Although maybe the characteristics of the hair are altered.
Donor dominance Spanish Dude........the hair retains its characteristics wherever its moved. The only thing that has been shown to change is the length *sometimes* that it will grow in the recipient location. *Some* body hair has grown longer on the head than it does on the body, but in many cases it does not. Body hair moved to the head will be kinky if it is on the body, or will be curly if it was curly on the body. Head hair moved to the body will have the exact color and texture that it did on your head, except that it will not grow long. Jahoda proved this many years ago.
» Maybe it is better to put the seeds on the scalp, and then replant the
» hairs with the correct direction.
Direction probably isn't the foremost of their concerns, lack of hair growth is. When have they said direction was a problem? 13% increases in the first phase two trial would be much more of a problem. If they are having both direction issues and lack of growth, it really is bad news.
» They could even use mice to pregrow the hairs, although this is an
» unpleasant idea.
Immunodeficient mice are available, but these creatures dont live very long. PETA would have an absolute fit for a gazillion lab mice to be used this way. Growing an ear in a lab mice's back to transplant to someone who has been born without an ear or has lost one is one thing, but utilizing them for things like hair would set off a firestorm of controversy. It will never happen.
»
» For me it is clear that the direction problem is not yet solved, and maybe
» that is why ICX lately mentioned about growing the hairs outside the body
» and then planting on the scalp.
Aderans is who is using biodegradable tissue matrixes in the body and creating cultures to where hair can grow outside of it for re-implantation (or trying to anyway), not Intercytex. Intercytex has said nothing about direction being a problem. ICX has mentioned nothing about growing hairs outside the body.
»
» If the direction is bad as I suspect, I don't see how these hairs can be
» used as "filler", unless the hairs are replanted. If the new hairs are
» chaotic, you will have a strange mixture of correct+chaotic hairs in the
» head, and the result will be pretty bad.
Its been mentioned on this forum that over time stromal tissue just might correct bad direction anyway. Notice alot of bad old transplants from the eighties when direction wasn't so good get better direction as the years go on alog with the grain of the other scalp hair. Its the plugginess that is an issue with them. I think you have talked yourself into thinking that direction is their problem at ICX. Its almost certainly the lack of thick growing hair that its the problem. They'd have happily given everyone a haircount if the hair had grown in thickly but haphazardly, but they didn't. One can keep their hair cut short if direction is a problem, but its almost assuredly not their problem as they havent mentioned it. Its growth.
»
» Also, lets remember that ARI has researched a lot in scaffolds, so they
» could join ICX and reach a viable solution.
This is true, if direction is a big problem. We'd know if one of them would release a photograph, or if Aderans would mention anything. But they dont...........and hence why the forum is becoming pointless. We just aren't given much information on continuing trial results. These entities have tests, but aren't willing to tell us how the tests are coming out. That is not a good thing. Indications that actually work, like finasteride........give you all kinds of stats and numbers on how much bigger the hairs get, how many more of them per square inch there are, show you pictures, etc. The more I think about how they didn't include even any statistical increases after this latest trial, the more I think that the improvements over the first phase two trial weren't very much. Maybe 5 out of 5 men grew hair, but it really does take 200 hairs per square inch to look pretty thick and 120 to even look "thinnish". People without MPB often have 400 or more hairs per square inch. When they say 13% increase in thinning areas, do you realize that might mean somebody who had a thin 50 hairs per square inch might have went to 57 hairs per square inch? Are the new hairs circumference thick or are they "thinnish" intermediate looking hairs?
WE dont know because they wont tell us. Thats why just checking up on ICX's and Aderans website about once a year is the only rational thing left to do. If they get into phase 2 at Aderans, maybe they put something up...........but other than David procuring an interview with them, we just aren't getting any answers at all anymore. It makes speculation pointless.
benji is located in [NA] and he is available to meet: NO |
Spanish Dude
22.03.2008, 15:42
@ benji
|
10 million dollar phase 3 FDA trial===on the cheap |
-About Donor Dominance: I have to refresh my memory here, but I think this is not completely true when you inject only DP cells. For example, the color of the hair is that of the receptor site. This is on Intercytex FAQs.
-Yes, direction is a concern for ICX. Its in this pdf. That is why they plan to use it as a filler at launch. Also, you can see in the FAQs that they are ellusive about the subject: "there should not be a problem because you are injecting cells" LOL.
-Yes, ICX is considering to grow hairs outside the body, or at least "protohairs": they have filed a patent.
http://www.hairsite.com/hair-loss/forum_entry.php?id=14113&page=0&category=1&order=last_answer
Also, I think it was Jerry Cooley who talked about it in a conference?
-It is true that ICX didn't tell us numbers, and this could indicate that they are having growth problems. But as I said, this was planned. If all the three formulations failed, they planned to keep trying new formulations. I am sure there are many variables to play with.
And we cannot say that these formulations failed, because the preestimulated patients all of them had increased numbers.
-I don't know if over time direction will correct by itself, but even in that case, it is a big problem if your hair looks horrible for years. In any event, I don't like the idea of using it as a filler. Mixing good hairs with slanted hairs is not a good idea. If that was acceptable, then using 100% HM will also be acceptable.
quote:
>>
WE dont know because they wont tell us. Thats why just checking up on ICX's and Aderans website about once a year is the only rational thing left to do. If they get into phase 2 at Aderans, maybe they put something up...........but other than David procuring an interview with them, we just aren't getting any answers at all anymore. It makes speculation pointless.
<<
I agree with this. With so little information that they are giving us, we can speculate and speculate, for nothing.
Paul Kemp interviews are quite informative, though.
Spanish Dude is located in [NA] and he is available to meet: NO |
James Bond
22.03.2008, 17:06
(edited by James Bond, 22.03.2008, 17:27)
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
» Apparently, they have money but just for the skin products.
»
» Well, if my new guessings are right, maybe we are lucky if they find
» someone to pay the bills.
» But of course, this is a big setback.
The economy in England is on a similar fast track to recession as the American economy due to their sophisticated banking structures (unlike Asian banks, which are sheltered from the current market fallout due to their lack of sophistication). This translates to money being more difficult to get (for ICX) and stock prices taking a beating in the immediate future. So this helps to infringe upon the already tight cash-flow of a startup biotech with a very radical vision for the future. I believe ICX prefers to continue development of this product, but the reality is that they need to start generating some form of income soon or the entire company will sink. Successful product development has just as much or more to do with business realities as it does scientific realities. The story of the Gho Clinic is a testimony to this with the main difference being ICX also tapped its ability to generate public funding.
Gho foresaw ICX in every step of this journey to date, and his journey reads like a prophetic prediction of ICX' fate. I was hoping that the large amount of cash ICX generated through public funding would lead them to a different outcome, but much of that has been swallowed up developing their more immediate products.
There are risks involved in continuing development, and ICX can't assume the risk due to the risks they have in every other product they are developing. Thus, they are trying to spread the risk by collaborating with another company. This will allow them to concentrate their cash on their more immediate products in an attempt to get some money rolling through the door to fund future development and increase investor confidence.
ICX believes the risk of TRC not being commercially marketable is low, so that is a good sign. However, the results are obviously not yet amazing enough to bring in the the money they need to push this product to phase III. Gho showed us how this game works. You get the hair to grow, but you can't get it to grow consistently. Then your investors start to complain they need an immediately marketable product to generate a return on investments. At this stage, Gho turned to the less than stellar FM. In a similar manner, ICX is turning to other products in its pipeline that are hopefully more desirable than FM turned out to be.
My opinion is that we are seeing history repeat itself. Gho did not fail purely for scientific reasons. He failed mostly due to business pressures and realities. ICX is being forced into a similar corner.
The good news is that the product grows increased hair on most or all people that use it (but so did Gho's version). In that respect, it is unique from everything else in the marketplace except for perhaps FM/HST. The biggest question is who wants to assume the risk of continuing to develop this product and partner with ICX?
The most important deviation from what we are seeing with ICX and Gho is that Gho lost the rights to sell his HM related research when he reached this stage of the game. ICX has managed to maintain it's rights to its HM product and can place it in the marketplace for any interested party to pick up. It is important to realize ICX is not looking to throw the product away. They are looking for a HT company to help fund the research and figure out how best to use the product. Due to the extreme limitations of HT that are directly addressed by TRC, it does not require a large stretch of the imagination to foresee this research being picked up and brought through to commercial success. The potential market is well into the billions. But we'll have to wait and see what happens.
The news is lackluster. I see no other way to portray it in light of the fact that this product cannot be marketed without the successful completion of phase III. My biggest question is whether ICX is going to be portrayed in the same unfair manner Gho was portrayed in when his efforts fell short? Will Kemp turn into a common four-letter word. Will he be accused of pumping TRC in order to generate public funds for skin products? I'm curious to see just how hard people retaliate, and I fully expect to see it surface at some level.
Okay, that's worst case scenario. Maybe best case is that a HT company will pick it up as is and offer it offshore (while continuing development in the lab). This will allow the 25% of patients that respond well to the treatment to get their hair back immediately. The other 75% are stuck with standard HT with a little added thickening. Sound implausible? I'd pay 3 grand to find out if I could get my hair back. Wouldn't you? And on top of that, even if you only get a little thickening, it still beats HT. All in all, not a bad business model as most of us would fly over and take our chances as long as a few people had amazing success. The bonus would be that the company would have massive data on the process and know exactly how deviating laboratory results could be turned into successful treatment results. Gho once made the statement about his own HM product, "I could market it right now, but it's not perfect yet." His business manager begged him to put it on the market as is and take his chances. IMO, ICX' product could probably be marketed right now by an intelligent CEO with a keen understanding of bald men's needs and desires. I think even my lame arse could turn this into a huge success, and I lack business skills. Imagine what others can do with the product.
James Bond is located in [NA] and he is available to meet: NO |
Spanish Dude
22.03.2008, 17:48
@ James Bond
|
Reconsidering my position about ICX. Going positive now. |
Well, I prefer not to talk about Gho, because this would lead to lengthy discussions with you, and frankly, I don't have the energy for that now.
And re. ICX, if they used TRC simply as a bait to get free advertising, I cannot tell at this point. But one thing is clear, they always had their priority on the skin products. Higgins said once that "Skin is the Holy grail" in an interview. They have spent very little money on TRC, maybe because they feel it is a more difficult product.
Unfortunately, ICX has chosen to give us very little information about the trials. Basically, no details about number of hairs, and no information at all about direction. This promotes our doubts.
But in spite of this, the truth is that they have given us much more information than any other HM researcher so far.
I think we will have to wait and see if someone puts money on TRC. If this doesn't occur, this will indicate that TRC doesn't have the potential that was promised, and then, yes, we could think that ICX used it simply as bait, once again, to fool us, and then, yes, people will get very upset.
Well, if they fail with TRC, but have success with the skin products, this will be a huge revolution in medicine, and the TRC matter will be excused.
Spanish Dude is located in [NA] and he is available to meet: NO |
gjh001
22.03.2008, 19:11
@ James Bond
|
Reconsidering my position about ICX. Going positive now. |
» » Apparently, they have money but just for the skin products.
» »
» » Well, if my new guessings are right, maybe we are lucky if they find
» » someone to pay the bills.
» » But of course, this is a big setback.
»
» The economy in England is on a similar fast track to recession as the
» American economy due to their sophisticated banking structures (unlike
» Asian banks, which are sheltered from the current market fallout due to
» their lack of sophistication). This translates to money being more
» difficult to get (for ICX) and stock prices taking a beating in the
» immediate future. So this helps to infringe upon the already tight
» cash-flow of a startup biotech with a very radical vision for the future.
» I believe ICX prefers to continue development of this product, but the
» reality is that they need to start generating some form of income soon or
» the entire company will sink. Successful product development has just as
» much or more to do with business realities as it does scientific
» realities. The story of the Gho Clinic is a testimony to this with the
» main difference being ICX also tapped its ability to generate public
» funding.
»
» Gho foresaw ICX in every step of this journey to date, and his journey
» reads like a prophetic prediction of ICX' fate. I was hoping that the
» large amount of cash ICX generated through public funding would lead them
» to a different outcome, but much of that has been swallowed up developing
» their more immediate products.
»
» There are risks involved in continuing development, and ICX can't assume
» the risk due to the risks they have in every other product they are
» developing. Thus, they are trying to spread the risk by collaborating with
» another company. This will allow them to concentrate their cash on their
» more immediate products in an attempt to get some money rolling through
» the door to fund future development and increase investor confidence.
»
» ICX believes the risk of TRC not being commercially marketable is low, so
» that is a good sign. However, the results are obviously not yet amazing
» enough to bring in the the money they need to push this product to phase
» III. Gho showed us how this game works. You get the hair to grow, but you
» can't get it to grow consistently. Then your investors start to complain
» they need an immediately marketable product to generate a return on
» investments. At this stage, Gho turned to the less than stellar FM. In a
» similar manner, ICX is turning to other products in its pipeline that are
» hopefully more desirable than FM turned out to be.
»
» My opinion is that we are seeing history repeat itself. Gho did not fail
» purely for scientific reasons. He failed mostly due to business pressures
» and realities. ICX is being forced into a similar corner.
»
» The good news is that the product grows increased hair on most or all
» people that use it (but so did Gho's version). In that respect, it is
» unique from everything else in the marketplace except for perhaps FM/HST.
» The biggest question is who wants to assume the risk of continuing to
» develop this product and partner with ICX?
»
» The most important deviation from what we are seeing with ICX and Gho is
» that Gho lost the rights to sell his HM related research when he reached
» this stage of the game. ICX has managed to maintain it's rights to its HM
» product and can place it in the marketplace for any interested party to
» pick up. It is important to realize ICX is not looking to throw the
» product away. They are looking for a HT company to help fund the research
» and figure out how best to use the product. Due to the extreme limitations
» of HT that are directly addressed by TRC, it does not require a large
» stretch of the imagination to foresee this research being picked up and
» brought through to commercial success. The potential market is well into
» the billions. But we'll have to wait and see what happens.
»
» The news is lackluster. I see no other way to portray it in light of the
» fact that this product cannot be marketed without the successful
» completion of phase III. My biggest question is whether ICX is going to be
» portrayed in the same unfair manner Gho was portrayed in when his efforts
» fell short? Will Kemp turn into a common four-letter word. Will he be
» accused of pumping TRC in order to generate public funds for skin
» products? I'm curious to see just how hard people retaliate, and I fully
» expect to see it surface at some level.
»
» Okay, that's worst case scenario. Maybe best case is that a HT company
» will pick it up as is and offer it offshore (while continuing development
» in the lab). This will allow the 25% of patients that respond well to the
» treatment to get their hair back immediately. The other 75% are stuck with
» standard HT with a little added thickening. Sound implausible? I'd pay 3
» grand to find out if I could get my hair back. Wouldn't you? And on top of
» that, even if you only get a little thickening, it still beats HT. All in
» all, not a bad business model as most of us would fly over and take our
» chances as long as a few people had amazing success. The bonus would be
» that the company would have massive data on the process and know exactly
» how deviating laboratory results could be turned into successful treatment
» results. Gho once made the statement about his own HM product, "I could
» market it right now, but it's not perfect yet." His business manager
» begged him to put it on the market as is and take his chances. IMO, ICX'
» product could probably be marketed right now by an intelligent CEO with a
» keen understanding of bald men's needs and desires. I think even my lame
» arse could turn this into a huge success, and I lack business skills.
» Imagine what others can do with the product.
JB is the only poster on here that I listen to, the one thing that I am intrigued about is that Gho's stem cell is as good as HM and its available, one thing I dont know is if it works. Wish someone on here had experience of it.
gjh001 is located in [NA] and he is available to meet: NO |
benji
22.03.2008, 19:20
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
"Okay, that's worst case scenario. Maybe best case is that a HT company will pick it up as is and offer it offshore (while continuing development in the lab). This will allow the 25% of patients that respond well to the treatment to get their hair back immediately. The other 75% are stuck with standard HT with a little added thickening. Sound implausible? I'd pay 3 grand to find out if I could get my hair back. Wouldn't you? And on top of that, even if you only get a little thickening, it still beats HT. All in all, not a bad business model as most of us would fly over and take our chances as long as a few people had amazing success. The bonus would be that the company would have massive data on the process and know exactly how deviating laboratory results could be turned into successful treatment results. Gho once made the statement about his own HM product, "I could market it right now, but it's not perfect yet." His business manager begged him to put it on the market as is and take his chances. IMO, ICX' product could probably be marketed right now by an intelligent CEO with a keen understanding of bald men's needs and desires. I think even my lame arse could turn this into a huge success, and I lack business skills. Imagine what others can do with the product."
I agree with the above verbiage 1000 percent. If the results are just a "thickening" of existing hair (including hair in the donor area which perhaps could be shot up also), it would be worth 5K to me personally. Id go to Antigua or whatever to have that done if they could just show me three photos of men who have a little more hair due to their procedure than before they had it and I believed the pictures to be true.
What I see is in September, they will (as Spanish dude has pointed out) have tried there three best protocols, and I hope they release data of what was made. I hope they are shooting up areas WITH hair also, to see if "thickening" can be accompished. anything that concened having a follicle "develop" there. The skin is thinner in bald scalp. A water layer is gone, fatty acids are missing, their is excessive collagen and less oxygen and less blood due to microcapillary insufficiency as compared with non-bald scalp. Its not a good environment for hair to grow. I wonder if they have noted better growth in already "fairly" hairy scalp that they have shot up vs. scalp with no hair at all.
The thought of Aderans getting to buy what ICX has, is kind of depressing. To get HM with them, will probably require a small strip............and I dont want a strip unless I have almost guaranteed results. Scars back there mean no buzzcut later if it fails. I wanted ICX to hit a home run in this trial.....................and was really secretely confident that they were going to have big success this time round' and we could have officially started the clock. Aderans isn't going to tell us anything. Ive emailed them four or five times asking them if they are in human trials, how are things going, what year will it be available, does it look promising...................and never get anything back. Hairsite hasn't apparently been able to get an interview with them.
The world eonomy, due to the high oil prices.........is going to be struggling for the next several years. The Bush monkey has hurt us all. If one could simply increase the thickness of their donor area by 50%---------most of us would be in the clear, and could get an FUE with terrific results by manually transplanting the fully differentiated hair.
I have always worried that bald scalp in human androgenic alopecia would present a hair growing problem with this...........but simply dont know for certain. Any way one slices it, it looks like it will be a few years yet, and that is very disheartening. I honestly believed 2010 was a real possibility six months ago. If Follica doesnt work in the relatively near term either, (a real possibility).......there is nothing else out there on the horizon at all.
It may be that a viable solution for bald men will really be 20 something years out there if that is the case, which sucks for all of us.
benji is located in [NA] and he is available to meet: NO |
James Bond
22.03.2008, 19:53
(edited by James Bond, 22.03.2008, 20:00)
@ Spanish Dude
|
Reconsidering my position about ICX. Going positive now. |
» But in spite of this, the truth is that they have given us much more information than any other HM researcher so far.
I disagree. Gho gave numerous lengthy interviews, published ground-breaking relevant HM research in the leading peer reviewed journal of the world, and even showed the owner of this site visual experimental results of HM hair growing on at least one patient's head. In addition he cited his hair growth results as a percentage of injections compared to hairs growing from his patients' heads. Thus, if he injected a hundred times and grew hair between 20 and 80% of the time, we were able to mathematically extrapolate these figures. He informed us of the quality of the hairs and the growth and direction (as confirmed by the owner of this website's sworn eye witness testimony). The list of forthcoming information goes on and on.
By contrast ICX put a PR secretary in charge of patient information who emailed blanket statements to desperate patients that, when the smoke settled, had very little in common with fact. Kemp's own statement of 66 hairs average per 100 injections made TRC seem like a miracle cure. This statement was made prior to a public stock offering that mostly funded products other than TRC. After that, we were provided blanket statements that made it seem as if ICX had improved the product's consistency beyond what had originally seemed to be a miracle cure. This was around the time ICX had announced a second public stock offering. All the while, ICX was releasing investor updates with bubbly speculative statements such as "commercial marketing in 2008 is a possibility" and "we expect phase III trials will be performed by such and such a date."
There is a 1000 times as much incriminating evidence out there with ICX than there ever was with Gho, and it is written in stone in public investor announcements that can be investigated and penalized by law. This does not mean that ICX is not on the level. It means you are clearly biased against Gho and in favor of ICX, and it shows.
The fact is, neither Gho or ICX' scientists are evil monsters. They are researchers who put in a massive amount of effort into achieving something that is very difficult to achieve. So far, neither research team has succeeded. And so far, neither research team has done anything different as far as ethical concerns go than the average biotech startup company in the US where ethics are closely monitored.
Much like you speculated that donor regrowth was a made up lie to promote FM, and I later proved you wrong by supplying a link to an independent research study that proved Gho's statements of donor regrowth to be 100% factual right down to the upper limit of consistency that could be expected, I am now calling you out on your continued bias and prejudice for and against particular research outfits based on your own personal vendettas. IMO, you spent years attacking and slandering an innocent man, his research, and his companies. In light of the latest developments of ICX TRC, I believe you owe Dr. Gho one heck of a personal apology. When the smoke settles, you have no more legitimate information against him than I have against ICX. Yet you don't see me personally attacking the character or the morality ICX. They have have not deviated in the slightest from industry standard in my opinion, and are actually better than most.
James Bond is located in [NA] and he is available to meet: NO |
dave21
22.03.2008, 21:04
@ James Bond
|
Reconsidering my position about ICX. Going positive now. |
» » But in spite of this, the truth is that they have given us much more
» information than any other HM researcher so far.
»
» I disagree. Gho gave numerous lengthy interviews, published
» ground-breaking relevant HM research in the leading peer reviewed journal
» of the world, and even showed the owner of this site visual experimental
» results of HM hair growing on at least one patient's head. In addition he
» cited his hair growth results as a percentage of injections compared to
» hairs growing from his patients' heads. Thus, if he injected a hundred
» times and grew hair between 20 and 80% of the time, we were able to
» mathematically extrapolate these figures. He informed us of the quality of
» the hairs and the growth and direction (as confirmed by the owner of this
» website's sworn eye witness testimony). The list of forthcoming
» information goes on and on.
»
» By contrast ICX put a PR secretary in charge of patient information who
» emailed blanket statements to desperate patients that, when the smoke
» settled, had very little in common with fact. Kemp's own statement of 66
» hairs average per 100 injections made TRC seem like a miracle cure. This
» statement was made prior to a public stock offering that mostly funded
» products other than TRC. After that, we were provided blanket statements
» that made it seem as if ICX had improved the product's consistency beyond
» what had originally seemed to be a miracle cure. This was around the time
» ICX had announced a second public stock offering. All the while, ICX was
» releasing investor updates with bubbly speculative statements such as
» "commercial marketing in 2008 is a possibility" and "we expect phase III
» trials will be performed by such and such a date."
»
» There is a 1000 times as much incriminating evidence out there with ICX
» than there ever was with Gho, and it is written in stone in public
» investor announcements that can be investigated and penalized by law. This
» does not mean that ICX is not on the level. It means you are clearly biased
» against Gho and in favor of ICX, and it shows.
»
» The fact is, neither Gho or ICX' scientists are evil monsters. They are
» researchers who put in a massive amount of effort into achieving something
» that is very difficult to achieve. So far, neither research team has
» succeeded. And so far, neither research team has done anything different
» as far as ethical concerns go than the average biotech startup company in
|
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