There’s a lot of excitement recently regarding Aderans starting phase II, but I remember back in 2003 when Dr. Washenik spoke about a 5 year timeline from that date until release of a product.
A biotech company will surely meet with roadbumps when testing a product, but I would not be surprised one bit if Aderans’ (and ICX’s) delays were caused by factors other than the sceince behind their technologies. Every new product that seeks FDA approval meets with resistance from interest groups that will be harmed by that new product’s release. Those interest groups can (and do) contact the FDA, and raise any and every objection (whether logical or not) regarding that new product. These objections can certainly affect the FDA’s mindset, and when the interest group that is contacting the FDA is a group of doctors (in our case, HT doc’s that know they will be harmed by the emergence of Aderans and ICX) the FDA will definitely listen.
So, to clarify my point, I wouldn’t be surprised if Aderans and ICX have been delayed because the FDA is making them jump through many, many hoops due to objections raised by HT doc’s who don’t want Aderans or ICX to succeed.
There is good news, though. We can find out what objections the HT doc’s have been raising. The US’s Freedom of Information Act allows people to request information from federal agencies, and this includes the FDA. I think it would be best if many of us request info from the FDA regarding the Aderans and ICX trials since that would give us a better chance that we’ll get a response. If anyone is interested, please let me know.
» There’s a lot of excitement recently regarding Aderans starting phase II,
» but I remember back in 2003 when Dr. Washenik spoke about a 5 year timeline
» from that date until release of a product.
»
» A biotech company will surely meet with roadbumps when testing a product,
» but I would not be surprised one bit if Aderans’ (and ICX’s) delays were
» caused by factors other than the sceince behind their technologies. Every
» new product that seeks FDA approval meets with resistance from interest
» groups that will be harmed by that new product’s release. Those interest
» groups can (and do) contact the FDA, and raise any and every objection
» (whether logical or not) regarding that new product. These objections can
» certainly affect the FDA’s mindset, and when the interest group that is
» contacting the FDA is a group of doctors (in our case, HT doc’s that know
» they will be harmed by the emergence of Aderans and ICX) the FDA will
» definitely listen.
»
» So, to clarify my point, I wouldn’t be surprised if Aderans and ICX have
» been delayed because the FDA is making them jump through many, many hoops
» due to objections raised by HT doc’s who don’t want Aderans or ICX to
» succeed.
»
» There is good news, though. We can find out what objections the HT doc’s
» have been raising. The US’s Freedom of Information Act allows people to
» request information from federal agencies, and this includes the FDA. I
» think it would be best if many of us request info from the FDA regarding
» the Aderans and ICX trials since that would give us a better chance that
» we’ll get a response. If anyone is interested, please let me know.
I have been saying this for a long time. There can be some ‘jiggery-pokery’ behind the scenes with matters such as these. The people who do not believe in corruption in cases like this usually are the ones who believe that their government has got their best interests at heart.
The cure will be constantly delayed but not by science.
» There’s a lot of excitement recently regarding Aderans starting phase II,
» but I remember back in 2003 when Dr. Washenik spoke about a 5 year timeline
» from that date until release of a product.
»
» A biotech company will surely meet with roadbumps when testing a product,
» but I would not be surprised one bit if Aderans’ (and ICX’s) delays were
» caused by factors other than the sceince behind their technologies. Every
» new product that seeks FDA approval meets with resistance from interest
» groups that will be harmed by that new product’s release. Those interest
» groups can (and do) contact the FDA, and raise any and every objection
» (whether logical or not) regarding that new product. These objections can
» certainly affect the FDA’s mindset, and when the interest group that is
» contacting the FDA is a group of doctors (in our case, HT doc’s that know
» they will be harmed by the emergence of Aderans and ICX) the FDA will
» definitely listen.
»
» So, to clarify my point, I wouldn’t be surprised if Aderans and ICX have
» been delayed because the FDA is making them jump through many, many hoops
» due to objections raised by HT doc’s who don’t want Aderans or ICX to
» succeed.
»
» There is good news, though. We can find out what objections the HT doc’s
» have been raising. The US’s Freedom of Information Act allows people to
» request information from federal agencies, and this includes the FDA. I
» think it would be best if many of us request info from the FDA regarding
» the Aderans and ICX trials since that would give us a better chance that
» we’ll get a response. If anyone is interested, please let me know.
If that’s possible then why hasn’t anyone done it before now.
» So, to clarify my point, I wouldn’t be surprised if Aderans and ICX have
» been delayed because the FDA is making them jump through many, many hoops
» due to objections raised by HT doc’s who don’t want Aderans or ICX to
» succeed.
»
» There is good news, though. We can find out what objections the HT doc’s
» have been raising. The US’s Freedom of Information Act allows people to
» request information from federal agencies, and this includes the FDA. I
» think it would be best if many of us request info from the FDA regarding
» the Aderans and ICX trials since that would give us a better chance that
» we’ll get a response. If anyone is interested, please let me know.
It is quite possible that might be the case. And we have very little to lose by requesting the material. If nothing else, the risk of being exposed by such a request for information could make companies, organisations, HT docs and lobbyists more hesitant to try to hinder the process in the future. After all, being exposed for trying to disrupt the competion and delaying a possible cure, just for your own financial gain, will NOT give you a good reputation.
I’m afraid that any objections etc revealed thereby will be “hidden” behind law firms and faceless organisations, though.
But you have my support. My moral support, that is. I’m not American, you see, so I can’t make the request.
I highly doubt icx and aderans are all set and ready to go and the ht lobby(if there is one) is stopping it. Even if a ht lobby were trying to , there are so many bald fda, govt officials i think they wouldnt let ht docs stop them.
»
» If that’s possible then why hasn’t anyone done it before now.
My guess: The number of people that know about Aderans and ICX, AND know about the ability to request info via the FOI Act, AND are proactive enough to do somehting about it is very, very small.
» I highly doubt icx and aderans are all set and ready to go and the ht
» lobby(if there is one) is stopping it. Even if a ht lobby were trying to ,
» there are so many bald fda, govt officials i think they wouldnt let ht docs
» stop them.
It’s silly to think that some ht lobbying groups can stop hair multiplication research, what is their argument for asking the govt to stop research?
» » I highly doubt icx and aderans are all set and ready to go and the ht
» » lobby(if there is one) is stopping it. Even if a ht lobby were trying
» to ,
» » there are so many bald fda, govt officials i think they wouldnt let ht
» docs
» » stop them.
»
» It’s silly to think that some ht lobbying groups can stop hair
» multiplication research, what is their argument for asking the govt to stop
» research?
WHile I will not rule out this (FDA) possibility, I don’t think that is the case here.
I believe it has more to do with the products potential/results and trying to get the “money” to continue the research on these products. If the product has potential or is obtaining adequate results then they get the green light to continue to the next step/phase of the products evolution.
For example, I am sure Bosley & the automation grant had a lot to do with ICX-TRC going into Phase II. Now ICX needs more money or a partnership to move on to Phase III (or whatever is the next step).
If you look at their latest report in September 2008, they stated that in 2008 “No revenue was received from Bosley under the ICX-TRC option” … in 2007 it was stated that “Milestone payment of US$200,000 received from Bosley under ICX-TRC option” …In the year ended 31 December 2007, revenue was £111k (2006: £83k), representing receipt of the fourth milestone from Bosley under the ICX-TRC option agreement.
ICX now knowing that the Bosley money is running out (who happened to put the most cash into the research) they knew that the only way to continue with ICX-TRC is to somehow get more money!!!
What happens if they can’t get the money? Research for ICX-TRC gets delayed or possibly STOPPED!!!
FDA may be a barrier but money and results usually pose a much bigger obstacle!!!
One thing I don’t like is that there was no mention of ICX-TRC in ICX’s future “OUTLOOK/GOALs” in their September 2008 report. Previously, they always made note of ICX-TRC. Possibly, they are not mentioning it since they still need to get the money/partnership they were looking for.
» WHile I will not rule out this (FDA) possibility, I don’t think that is the
» case here.
»
» I believe it has more to do with the products potential/results and trying
» to get the “money” to continue the research on these products. If the
» product has potential or is obtaining adequate results then they get the
» green light to continue to the next step/phase of the products evolution.
»
» For example, I am sure Bosley & the automation grant had a lot to do with
» ICX-TRC going into Phase II. Now ICX needs more money or a partnership to
» move on to Phase III (or whatever is the next step).
»
» If you look at their latest report in September 2008, they stated that in
» 2008 “No revenue was received from Bosley under the ICX-TRC option” … in
» 2007 it was stated that “Milestone payment of US$200,000 received from
» Bosley under ICX-TRC option” …In the year ended 31 December 2007,
» revenue was £111k (2006: £83k), representing receipt of the fourth
» milestone from Bosley under the ICX-TRC option agreement.
»
»
» ICX now knowing that the Bosley money is running out (who happened to put
» the most cash into the research) they knew that the only way to continue
» with ICX-TRC is to somehow get more money!!!
»
» What happens if they can’t get the money? Research for ICX-TRC gets
» delayed or possibly STOPPED!!!
»
» FDA may be a barrier but money and results usually pose a much bigger
» obstacle!!!
»
»
» One thing I don’t like is that there was no mention of ICX-TRC in ICX’s
» future “OUTLOOK/GOALs” in their September 2008 report. Previously, they
» always made note of ICX-TRC. Possibly, they are not mentioning it since
» they still need to get the money/partnership they were looking for.
I spoke with Dr. Washeniks secretary and indeed she did mention that the FDA was making ARI “jump through hoops” so to speak.
» » WHile I will not rule out this (FDA) possibility, I don’t think that is
» the
» » case here.
» »
» » I believe it has more to do with the products potential/results and
» trying
» » to get the “money” to continue the research on these products. If the
» » product has potential or is obtaining adequate results then they get
» the
» » green light to continue to the next step/phase of the products
» evolution.
» »
» » For example, I am sure Bosley & the automation grant had a lot to do
» with
» » ICX-TRC going into Phase II. Now ICX needs more money or a partnership
» to
» » move on to Phase III (or whatever is the next step).
» »
» » If you look at their latest report in September 2008, they stated that
» in
» » 2008 “No revenue was received from Bosley under the ICX-TRC option” …
» in
» » 2007 it was stated that “Milestone payment of US$200,000 received from
» » Bosley under ICX-TRC option” …In the year ended 31 December 2007,
» » revenue was £111k (2006: £83k), representing receipt of the fourth
» » milestone from Bosley under the ICX-TRC option agreement.
» »
» »
» » ICX now knowing that the Bosley money is running out (who happened to
» put
» » the most cash into the research) they knew that the only way to
» continue
» » with ICX-TRC is to somehow get more money!!!
» »
» » What happens if they can’t get the money? Research for ICX-TRC gets
» » delayed or possibly STOPPED!!!
» »
» » FDA may be a barrier but money and results usually pose a much bigger
» » obstacle!!!
» »
» »
» » One thing I don’t like is that there was no mention of ICX-TRC in ICX’s
» » future “OUTLOOK/GOALs” in their September 2008 report. Previously, they
» » always made note of ICX-TRC. Possibly, they are not mentioning it since
» » they still need to get the money/partnership they were looking for.
»
»
» I spoke with Dr. Washeniks secretary and indeed she did mention that the
» FDA was making ARI “jump through hoops” so to speak.
I dont’t know wich kind of people get a transplant now… the transplant is good only for particular situations, with low diradation and a very very slow hairloss… also, with a transplant, you can risk to damage the donor area for hypotetical future cells treatments… so, for example, i’m waiting something that seriously work, and i have no idea to get a transplant. And will be good, if the situation with the fda is like this, with hoops by the fda, that all the people stop to get ridicolous transplant with few hair and will wait with presence a better future solution.
Well, the point is that even if it is unlikely that lobbyists are trying to delay the progress, it is still possible. And since we have nothing to lose by checking up on it, why not go ahead and do it?
You can wait around forever until your head is as shiny as a nickel and you’re 65 when your hair won’t even matter by then. Nothing is wrong with waiting, but to put all your hopes and eggs into one basket is not a smart move. As we would all love for these claims by these studies to be true, we all know for fact that their two yrs can easily turn into 15 yrs - if ANYTHING at all.
There is nothing wrong with a hair transplant. Follicles will always be available for the future miracle cell duplication methods. Until then, most of us would like to have hair.
» » » WHile I will not rule out this (FDA) possibility, I don’t think that
» is
» » the
» » » case here.
» » »
» » » I believe it has more to do with the products potential/results and
» » trying
» » » to get the “money” to continue the research on these products. If the
» » » product has potential or is obtaining adequate results then they get
» » the
» » » green light to continue to the next step/phase of the products
» » evolution.
» » »
» » » For example, I am sure Bosley & the automation grant had a lot to do
» » with
» » » ICX-TRC going into Phase II. Now ICX needs more money or a
» partnership
» » to
» » » move on to Phase III (or whatever is the next step).
» » »
» » » If you look at their latest report in September 2008, they stated
» that
» » in
» » » 2008 “No revenue was received from Bosley under the ICX-TRC option”
» …
» » in
» » » 2007 it was stated that “Milestone payment of US$200,000 received
» from
» » » Bosley under ICX-TRC option” …In the year ended 31 December 2007,
» » » revenue was £111k (2006: £83k), representing receipt of the fourth
» » » milestone from Bosley under the ICX-TRC option agreement.
» » »
» » »
» » » ICX now knowing that the Bosley money is running out (who happened to
» » put
» » » the most cash into the research) they knew that the only way to
» » continue
» » » with ICX-TRC is to somehow get more money!!!
» » »
» » » What happens if they can’t get the money? Research for ICX-TRC gets
» » » delayed or possibly STOPPED!!!
» » »
» » » FDA may be a barrier but money and results usually pose a much bigger
» » » obstacle!!!
» » »
» » »
» » » One thing I don’t like is that there was no mention of ICX-TRC in
» ICX’s
» » » future “OUTLOOK/GOALs” in their September 2008 report. Previously,
» they
» » » always made note of ICX-TRC. Possibly, they are not mentioning it
» since
» » » they still need to get the money/partnership they were looking for.
» »
» »
» » I spoke with Dr. Washeniks secretary and indeed she did mention that
» the
» » FDA was making ARI “jump through hoops” so to speak.
»
» I dont’t know wich kind of people get a transplant now… the transplant
» is good only for particular situations, with low diradation and a very very
» slow hairloss… also, with a transplant, you can risk to damage the donor
» area for hypotetical future cells treatments… so, for example, i’m
» waiting something that seriously work, and i have no idea to get a
» transplant. And will be good, if the situation with the fda is like this,
» with hoops by the fda, that all the people stop to get ridicolous
» transplant with few hair and will wait with presence a better future
» solution.
If it is true that Aderans or Intercytex or whoever can bring true HM to market, I seriously doubt that lack of donor would ever be an issue. Furthermore, I believe that, if it is true HM, even NW 7+ will have more than adequate donor.
» You can wait around forever until your head is as shiny as a nickel and
» you’re 65 when your hair won’t even matter by then. Nothing is wrong with
» waiting, but to put all your hopes and eggs into one basket is not a smart
» move. As we would all love for these claims by these studies to be true,
» we all know for fact that their two yrs can easily turn into 15 yrs - if
» ANYTHING at all.
»
» There is nothing wrong with a hair transplant. Follicles will always be
» available for the future miracle cell duplication methods. Until then,
» most of us would like to have hair.
»
»
» » » » WHile I will not rule out this (FDA) possibility, I don’t think
» that
» » is
» » » the
» » » » case here.
» » » »
» » » » I believe it has more to do with the products potential/results and
» » » trying
» » » » to get the “money” to continue the research on these products. If
» the
» » » » product has potential or is obtaining adequate results then they
» get
» » » the
» » » » green light to continue to the next step/phase of the products
» » » evolution.
» » » »
» » » » For example, I am sure Bosley & the automation grant had a lot to
» do
» » » with
» » » » ICX-TRC going into Phase II. Now ICX needs more money or a
» » partnership
» » » to
» » » » move on to Phase III (or whatever is the next step).
» » » »
» » » » If you look at their latest report in September 2008, they stated
» » that
» » » in
» » » » 2008 “No revenue was received from Bosley under the ICX-TRC option”
» » …
» » » in
» » » » 2007 it was stated that “Milestone payment of US$200,000 received
» » from
» » » » Bosley under ICX-TRC option” …In the year ended 31 December
» 2007,
» » » » revenue was £111k (2006: £83k), representing receipt of the fourth
» » » » milestone from Bosley under the ICX-TRC option agreement.
» » » »
» » » »
» » » » ICX now knowing that the Bosley money is running out (who happened
» to
» » » put
» » » » the most cash into the research) they knew that the only way to
» » » continue
» » » » with ICX-TRC is to somehow get more money!!!
» » » »
» » » » What happens if they can’t get the money? Research for ICX-TRC gets
» » » » delayed or possibly STOPPED!!!
» » » »
» » » » FDA may be a barrier but money and results usually pose a much
» bigger
» » » » obstacle!!!
» » » »
» » » »
» » » » One thing I don’t like is that there was no mention of ICX-TRC in
» » ICX’s
» » » » future “OUTLOOK/GOALs” in their September 2008 report. Previously,
» » they
» » » » always made note of ICX-TRC. Possibly, they are not mentioning it
» » since
» » » » they still need to get the money/partnership they were looking for.
» » »
» » »
» » » I spoke with Dr. Washeniks secretary and indeed she did mention that
» » the
» » » FDA was making ARI “jump through hoops” so to speak.
» »
» » I dont’t know wich kind of people get a transplant now… the
» transplant
» » is good only for particular situations, with low diradation and a very
» very
» » slow hairloss… also, with a transplant, you can risk to damage the
» donor
» » area for hypotetical future cells treatments… so, for example, i’m
» » waiting something that seriously work, and i have no idea to get a
» » transplant. And will be good, if the situation with the fda is like
» this,
» » with hoops by the fda, that all the people stop to get ridicolous
» » transplant with few hair and will wait with presence a better future
» » solution.
yes, nothing against a transplant, but if you are a nw 1,2… or maybe 3. After that, a transplant is a waste of money, is an illusion of hairs, people see you like a man with not so much hair… and i think is the same. bald or few hairs, no difference. So, if you can, to wait is better.
I was told by a helpful Hairsiter that someone who is much more knowledgeable than me about the topic actually posted an article on Hairsite years ago about HM, the Freedom of Information Act and the FDA. I checked it out; here’s the link:
You need to remember that back then this forum was all Dr Gho and a sprinkle of Dr Bazan. Just like now, many posters were guessing when HM would be out… and discussing why HM may be stalling. Funny thing is that the person (JTR) who came up with this conspiracy theory is also the person who had the earliest predicted date (April 2004!) of when HM would be out.
I spoke to Dr Gho about 1 year after this Nov 2002 post. Yes, he was concerned about the FDA approving his HM but it had nothing to do with the safety of his HM nor did he ever suggest any conspiracy theory. It was more due to Dr Gho’s HM protocol inconsistency. Dr Gho pointed out that he was researching several protocols. His results showed that several of the protocols showed good results with some people and not so good with others. Dr Gho had said the FDA would never go for approving all his protocols. The FDA told Dr Gho that they would approve only if Dr Gho can show 1 protocol with a certain amount of consistency.
While Dr Gho may have been frustrated with the FDA’s suggestion he never claimed it to be a CONSPIRACY THEORY. He did agree with the FDA in that it wasn’t right to commercialize his HM when many potential customers would be disappointed in their results.
Dr Gho admitted that he didn’t have the expertise in certain areas of HM and was looking for help.
About a year later Dr Gho said that he would come out with his HM, as early as 2004 and 2007 at the latest. Yes, even if he has no further advancements. HE SAID EVEN IF THE FDA DOESN’T APPROVE HIS PROTOCOLS!!! Dr Gho knew that certain countries would give him the go ahead, including his home country of Holland.
As you all know, Dr Gho never came out with his HM. Still, Dr Gho always stated that it had more to do with his HM results and eventually his financial situation. Just as I mentioned above with ICX.
ICX-TRC research was getting financial help from Bosley and gov’t grants. Now ICX is reluctant to continue until they get more financial help. If their Phase II results show enough potential to get Bosley or another partnership then this product has a chance.
This is an advertising site for paid
advertisers to showcase successful hair restoration results only. It is not the
mandate of this site to engage in the discussion of failed, unsuccessful
procedures, lawsuits, litigations, refunds or complaint cases. Surgical hair
restoration procedures carry risks. Please do thorough research, consult your
own physician and investigate a doctor's background carefully before making a
decision. By proceeding to use our site, you agree to abide by our Terms of Use & Privacy Policy at http://hairsite.com/terms-of-use/ where you can also find a list of HairSite's sponsoring physicians.
I’m not American, you see, so I can’t make the request.