I have discovered this document about IND.
There is a contradiction: Zohar says that they will begin human trials this year (2008), but no human trials can be done without the permission from FDA through IND process.
So, are the 2/3 years reported at the time launching in the market as in the past David Steinberg and George Cotsarelis said?
Another contradiction: Zoahr says in another interview that she doesn’t need to go through clinical trials because the devices/drugs are already approved.
Does she maybe want protect your finding because they are a private company?
in first place… he was not daphne zohar who said this on 3 years for new drug. this pdf is an article on fincanças and new drugs and treatments. any one can write what to understand, or not to understand, as for example, 3 years for this NEW DRUG, what it could be understood as 3 years for the LAUNCHING OF a NEW TYPE OF TREATMENT FOR CALVIÇIE. what it could be as the date stipulated for follica in interviews. what I do not understand in this site, because some always try to be pessimistic to the extremity.
I’ve read a couples of articles about Melanotan and it sounds really interesting… Can you suggest an online shop where to buy it? Thanks!
(If you don’t want to post links here, you can send me an email to zed.hairsite@mailinator.com)
» 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.
Sorry baldlatino but this article looks the most credible out of all. It is an article directly designed to reach potential investors and venture capitalists.
These are the guys who would sue follica if they lied.
If something is extreme here then its your naivity.
» Sorry baldlatino but this article looks the most credible out of all. It is
» an article directly designed to reach potential investors and venture
» capitalists.
»
» These are the guys who would sue follica if they lied.
»
» If something is extreme here then its your naivity.
» Okay, this is what I think it means:
»
» This summer’s 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 home…
»
» 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’m confused… I thought an IND was a collaboration of animal studies, toxicology data, and the protocol the investigators set forth for their upcoming clincial trials. Once the application is approved then they can commence clincal trials (phase I). If Follica is planning on initiating testing in human subjects in the later half of this year isn’t this considered phase I? Is the 2-3 years implying NDA (New Drug Application)?
» I’m confused… I thought an IND was a collaboration of animal studies,
» toxicology data, and the protocol the investigators set forth for their
» upcoming clincial trials. Once the application is approved then they can
» commence clincal trials (phase I). If Follica is planning on initiating
» testing in human subjects in the later half of this year isn’t this
» considered phase I? Is the 2-3 years implying NDA (New Drug Application)?
Yes, I am also confused. I think the normal sequence would be:
-Preclinical (animal)
-IND
-Phase 1,2,3
but in this case, the preclinical is done on humans??
I don’t think this summer trial is Phase1, nor 2.
They said this small trial would give a “Proof of concept” or something like that.
Sure, there is a forum on the web at www.melatonan.org in the discussion area you could find all the documentation, known sides, prices, differences between both peptides Melanotan One and two etc… and sellers in the market,
» I’ve read a couples of articles about Melanotan and it sounds really
» interesting… Can you suggest an online shop where to buy it? Thanks!
» (If you don’t want to post links here, you can send me an email to
» zed.hairsite@mailinator.com)
»
» » 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.
You are right , I am also from Spain.
When I mean that someone will do a " do it at home" experiment of regrowth I believe that is very probably that in case an effective and succesfully method will appear wich make us regrow hair, is very probably that will be available before in the Underground market than in the legals channels. I don´t know if it will be Follica or not, Due to the apparently easy way to do the Follica Method, would be very interesting that it could work.
Melanotan I and II are in use and they are not yet approved, HCG, Melatonin ( in some countries), PT141, and a lot more that I don´t know.
I have always wonder myself that why in other countries with a legality not as strict as the FDA , doen´t appear untested or not very tested inclusive risky methods of hair regrowth, cancer cure, etc…
I hear about a russian clinic where with stem cells they provide new skin free of wrinkles to mature womans, probably it is bullsh…, who knows !!!
» » 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;
» ojalá 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.
Dr. Cotsarelis said 2-3 years. That was over a year ago. And they still haven’t started trials. You can’t believe what anybody says with this stuff. Timelines from those involved have been notoriously inaccurate from every person or company to do with HM, Follica, etc.
»
» 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, we’d know about it by now. Want to know why? Because the lawyers
» would have already started the class action suit.
Not sure I agree with this. I personally think the side-effects are much greater than 2% as reported. Sexual side-effects are usually underreported. There is even a site dedicated to those who have sexual side effects from Propecia that won’t go away even after they quit taking the drug.
But even if it is greater than 2%, even if it is 10%, it would be very hard to prove. And even if you could prove it, how is a lawyer going to get a class action suit together where their clients pretty much have to admit, yeah, I was embarrassed about my hairloss and now my dick doesn’t work. It would be pretty hard to get a group of guys like that together and admit that, especially since the lawyers make most of the money on class action suits, not the clients.
I wasn’t meaning to derail the conversation onto a discussion of Propecia sides. I was just pointing out that the FDA’s safety demands aren’t all they’re cracked up to be.
If Folica’s process kills 1/3rd of the trialists then it obviously won’t get passed.
But suppose it works awesome for hair, and Folica is pushing the money hard, and people like US HERE are baying for it? That would influence the decision for sure.
Suppose they’re having nagging concerns about potential cancerous effects . . . and Folica insists that it’s “unrelated” and claims these issues are showing mainly in a fraction of the patients that already had other red flags for cancer already . . . and it would take decades to hold it off the market to REALLY know . . .
I’m just saying FDA safety approval is not handed down from God on stone tablets. (And it’s usually potential patients like us that are screaming loudest for early approval of an untested thing.)
» » On TV they lie every day. Try searching for iraq war reports, find
» » american, european and then arabian report of the same event. You’ll
» find
» » these are 3 totaly different stories.
»
» ummm you’re 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 don’t
» see how this product’s release won’t 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 they’ll compose their new concoction. Trying saying that
» for ICX or Aderans.
»
»
»
» .
I agree w/ you rev. We can’t disregard these statements, but we also shouldn’t disregard that this article is from January and were probably made sometime in December. Also, if you run a google search, this is the only article that mentions this IND for follica. Plans can change either way for follica; the process could take longer than first expected or shorter. The main thing is that clinical trials need to start and results need to be found.
I’m waiting for two things: follica trials to start this year (as we’ve heard from them many times) and for Acell to release for humans at the end of this year (again, as we’ve heard from Acell more than once).
FACT: It always takes longer than we expect. I’d say 3 years would be too early for Follica, mainly because of testing, approval, and marketing. More like 5 years. See y’all in 2013!
» I have always wonder myself that why in other countries with a legality
» not as strict as the FDA , doen´t appear untested or not very tested
» inclusive risky methods of hair regrowth, cancer cure, etc…
»
» I hear about a russian clinic where with stem cells they provide new skin
» free of wrinkles to mature womans, probably it is bullsh…, who knows !!!
»
»
»
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