http://www.helixis.com/news_events/2008/START-UP_Alist.pdf
Zohar says 2/3 years , but for IND application process!
» http://www.helixis.com/news_events/2008/START-UP_Alist.pdf
»
» Zohar says 2/3 years , but for IND application process!
2-3 years for phase-0âŠquite a lot!
» » http://www.helixis.com/news_events/2008/START-UP_Alist.pdf
» »
» » Zohar says 2/3 years , but for IND application process!
»
» 2-3 years for phase-0âŠquite a lot!
There are 10 pages of fine print, I am sorry I am at work and I donât have time to go through all the pages, can someone tell me what IND means?
it says human trials will start this year.
The article is from Jan 2008.
» it says human trials will start this year.
» The article is from Jan 2008.
If that article is true (and there isnât anyother info about trials, so iâm assuming it is) then what that means is that the trials Follica would be done this year are going to be on very small number of people. And will be part of phase-0.
IND stands for Investigational New Drug: See Wikipedia âClinical Trialsâ, it has info on all phases for trials.
» » it says human trials will start this year.
» » The article is from Jan 2008.
»
» If that article is true (and there isnât anyother info about trials, so
» iâm assuming it is) then what that means is that the trials Follica would
» be done this year are going to be on very small number of people. And will
» be part of phase-0.
»
» IND stands for Investigational New Drug: See Wikipedia âClinical Trialsâ,
» it has info on all phases for trials.
Okay, this is what I think it means:
This summerâs trials will be preclinical trials.
Then, in 2 or 3 years, they will file for an IND application.
Then, PhaseI
Then, Phase II
Then, Phase III
Then, launch in 2020 IF EVERYTHING GOES WELL.
Now you will tell me: oh, no, the ingredients are already approved, so after the preclinical trials, we will be able to know if it works, and we will do it at homeâŠ
well, ICX is in Phase II, and they have not released any photos, nor information about quality of the hairs yet. So why do you think Follica is going to give us all the info of the preclinical trials so that we can do it at home?
» » » it says human trials will start this year.
» » » The article is from Jan 2008.
» »
» » If that article is true (and there isnât anyother info about trials, so
» » iâm assuming it is) then what that means is that the trials Follica
» would
» » be done this year are going to be on very small number of people. And
» will
» » be part of phase-0.
» »
» » IND stands for Investigational New Drug: See Wikipedia âClinical
» Trialsâ,
» » it has info on all phases for trials.
»
» Okay, this is what I think it means:
»
» This summerâs trials will be preclinical trials.
» Then, in 2 or 3 years, they will file for an IND application.
» Then, PhaseI
» Then, Phase II
» Then, Phase III
» Then, launch in 2020 IF EVERYTHING GOES WELL.
»
» Now you will tell me: oh, no, the ingredients are already approved, so
» after the preclinical trials, we will be able to know if it works, and we
» will do it at homeâŠ
»
» well, ICX is in Phase II, and they have not released any photos, nor
» information about quality of the hairs yet. So why do you think Follica is
» going to give us all the info of the preclinical trials so that we can do
» it at home?
I totally agree; if what this article says is true, it will be available in 2015-2020 if it works.
But better be mad and conscious then dreaming.
This is 5 years (if clinical trials were fast forward on steroids, for which I do not see any reason, FDA in fact makes money by forcing everyone to go through trials ⊠so it is in their interest to force even follica to do so) or possibly even more then a decade away.
I think that the real only hope is home made HM 
It sounds silly and naive, but look where these scientists got us. Rogaine, and propecia. Average natural hair loss board member can do better than that.
I wonder what you guys are going to jump on now. ACell?
Iâve got no idea whether this is true or not.
The Folica drugs are all legal. Dermabrasionâs legal. The total bill for an attempt would cost a fraction of a decent HTâs price.
Itâs only a matter of time.
» » » it says human trials will start this year.
» » » The article is from Jan 2008.
» »
» » If that article is true (and there isnât anyother info about trials, so
» » iâm assuming it is) then what that means is that the trials Follica
» would
» » be done this year are going to be on very small number of people. And
» will
» » be part of phase-0.
» »
» » IND stands for Investigational New Drug: See Wikipedia âClinical
» Trialsâ,
» » it has info on all phases for trials.
»
» Okay, this is what I think it means:
»
» This summerâs trials will be preclinical trials.
» Then, in 2 or 3 years, they will file for an IND application.
» Then, PhaseI
» Then, Phase II
» Then, Phase III
» Then, launch in 2020 IF EVERYTHING GOES WELL.
»
» Now you will tell me: oh, no, the ingredients are already approved, so
» after the preclinical trials, we will be able to know if it works, and we
» will do it at homeâŠ
»
» well, ICX is in Phase II, and they have not released any photos, nor
» information about quality of the hairs yet. So why do you think Follica is
» going to give us all the info of the preclinical trials so that we can do
» it at home?
ICX has really demoralized everyone on this forum. 12 years is an utterly absurd timescale if the process shows consistent growth. Follica isnât trying to teraform Mars; theyâre merely recycling drugs. And speaking of recycling drugs. Hereâs a link I posted earlier.
On average, recycling drugs changes time scales from say 15 years to two years.
.
» ICX has really demoralized everyone on this forum. 12 years is an utterly
» absurd timescale if the process shows consistent growth. Follica isnât
» trying to teraform Mars; theyâre merely recycling drugs. And speaking of
» recycling drugs. Hereâs a link I posted earlier.
»
» The Drug Resurrector | Popular Science
» On average, recycling drugs changes time scales from say 15 years to two
» years.
okay, from your article:
If a drug has already been approved for other uses, it can skip past the initial safety trials and go directly into whatâs called phase II trials, which take only about two years.
<<
Maybe Phase I can be skipped. This is very debatable, because if you use several approved drugs at the same time, in theory, safety trials should be conducted to look for possible cross-reactions between those drugs. I mean, complex side effects. Maybe those drugs are safe used individually, but not used in combination. Furthermore, the FDA coud be tougher because they consider that baldness is a cosmetic problem only, so they prefer to err on the safe side.
And even if Phase I could be skipped, they would need efficacy trials, Phase II and III, and this would take time. They would need to test different dossages, different methods, etc. Maybe not 12 years, but surely 6 years. Note Zoharâs words: after this summerâs trial, they will need 2 or 3 years to file for an IND. So they are being quite slow!!
Sorry, but right now, I think ICX is still our best hope.
» Iâve got no idea whether this is true or not.
»
»
»
»
» The Folica drugs are all legal. Dermabrasionâs legal. The total bill for
» an attempt would cost a fraction of a decent HTâs price.
»
» Itâs only a matter of time.
Anyone who tries that is crazy. First, there could be side-effects. Second, the protocol could be very precise and sensitive, in which case getting decent results may be difficult.
I think that depends greatly on your viewpoint.
Taking some already-approved drugs and hoping they donât interact too badly . . . versus paying $15K for a strip scar and some mediocre hair improvement?
Or else just spending another decade of your life with MPB, and all the indirect negatives of that?
And we all know how much good the FDAâs 3-stage safety trials did for protecting Vioxx patients.
And Iâm glad the FDA made sure the sexual side effects from Propecia are really all in our heads too. Otherwise I might worry about taking a drug that squashes the sex drives of me and at least half of the other patients that I come across. Especially since some of them have complained that the effects are still there years after quitting.
Unknown dosages for Folica?
Even if you have to do the process several times over before you get it right, itâs basically still not much compared to the cost of one real HT.
» I think that depends greatly on your viewpoint.
»
»
»
» Taking some already-approved drugs and hoping they donât interact too
» badly . . . versus paying $15K for a strip scar and some mediocre hair
» improvement?
»
» Or else just spending another decade of your life with MPB, and all the
» indirect negatives of that?
»
» And we all know how much good the FDAâs 3-stage safety trials did for
» protecting Vioxx patients.
»
» And Iâm glad the FDA made sure the sexual side effects from Propecia are
» really all in our heads too. Otherwise I might worry about taking a drug
» that squashes the sex drives of me and at least half of the other patients
» that I come across. Especially since some of them have complained that the
» effects are still there years after quitting.
»
»
»
»
» Unknown dosages for Folica?
»
» Even if you have to do the process several times over before you get it
» right, itâs basically still not much compared to the cost of one real HT.
wow, so this is depressingâŠjust kinda sad because on TV they somehow feel itâs fine to say that itâll be out on the market within two to three years
On TV they lie every day. Try searching for iraq war reports, find american, european and then arabian report of the same event. Youâll find these are 3 totaly different stories.
» On TV they lie every day. Try searching for iraq war reports, find
» american, european and then arabian report of the same event. Youâll find
» these are 3 totaly different stories.
ummm youâre talking about a botched war, a grossly inept president, and a modern-day international disaster. Dave21 is talking about an American company (run by academics) covered by Dr. Nancy Snyderman on a well respected morning show. That barely constitutes a comparison between apples and oranges no matter how you slice it and dice it or peel it.
Secondly this report, most likely, predates the NBC piece.
Thirdly, people should stop quibbling over the minor details and worry about the main concern: will it work on humans? If it does, than I donât see how this productâs release wonât mirror the estimates given by Dr. Nancy Snyderman and Dr. Cotsarelis in that NBC piece.
Lastly, an IND might be a good thing; it could indicate Follica has a general idea how theyâll compose their new concoction. Trying saying that for ICX or Aderans.
.
edited.
Just as Cal says, It is a matter ot time, I am sure that someone will achieve a great regrowth at home with proofs in images, after that someone will copy the experiment and will keep posting the results in any forum and this will be the start, It is also the same than peptide called Melanotan, it is still not approved for human use, still in his latest phase II, but thousand of people are trying it at home, I also do it.
» I think that depends greatly on your viewpoint.
»
»
»
» Taking some already-approved drugs and hoping they donât interact too
» badly . . . versus paying $15K for a strip scar and some mediocre hair
» improvement?
»
» Or else just spending another decade of your life with MPB, and all the
» indirect negatives of that?
»
» And we all know how much good the FDAâs 3-stage safety trials did for
» protecting Vioxx patients.
»
» And Iâm glad the FDA made sure the sexual side effects from Propecia are
» really all in our heads too. Otherwise I might worry about taking a drug
» that squashes the sex drives of me and at least half of the other patients
» that I come across. Especially since some of them have complained that the
» effects are still there years after quitting.
»
»
»
»
» Unknown dosages for Folica?
»
» Even if you have to do the process several times over before you get it
» right, itâs basically still not much compared to the cost of one real HT.
Well, the best of luck to those trying it, but I doubt they would achieve what could be labeled a success, while at the same time taking an unknown risk.
As for Propecia, its been on the market in one form or another for 20 years, and has gone through 2 sets of complete trials. If there were a greater incidence of side-effects than those observed in those sets of trials, weâd know about it by now. Want to know why? Because the lawyers would have already started the class action suit.
» Just as Cal says, It is a matter ot time, I am sure that someone will
» achieve a great regrowth at home with proofs in images, after that someone
» will copy the experiment and will keep posting the results in any forum and
» this will be the start, It is also the same than peptide called Melanotan,
» it is still not approved for human use, still in his latest phase II, but
» thousand of people are trying it at home, I also do it.
RiuraO, let me tell you : such a believer you are, y sigo en español porque creo que los dos somos de los actuales reinos de taifas ex-pañoles; ojalå tuvieses razón pero los milagros no existen, yo he visitado estos foros durante años y he leido toda clase de experimentos y testimonios, y te digo que las sustancias milagrosas no existen, y que desgraciadamente no estamos mucho mejor que hace 5 años. Un saludo.