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Anyones got a link to an official Follica claim that they may skip the trials?


#1

Can you please post it here?


#2

"Zohar says Follica has further developed this work and filed additional patents to protect the technology. What’s so beautiful about the approach, she says, is that translating it into a treatment for humans involves only devices and drugs that are already on the market. A doctor would first use a microdermabrasion tool, say, or a laser to remove the top layers of the skin—as is already commonly done in a number of dermatologic and cosmetic procedures—knocking some cells back into a primitive state. The doctor can then use this newly created therapeutic window to inject drugs that push the cells to develop along one pathway or another and grow hair or skin. Zohar won’t reveal what drugs Follica is using, except to say that they are small molecule drugs normally taken orally for purposes with no relation to hair growth.

Because the components of the system are already approved, the regulatory path is pretty straightforward, and Follica can perform human studies without jumping through a lot of governmental hoops. That’s exactly what the company plans to do with the money it has just raised. A proof of concept study involving 15 to 20 patients (Follica has no shortage of volunteers, as several hundred people sent in e-mails when word of Cotsarelis’s work reached the public) should begin in the next few months. The trial has several phases, however, and Zohar cautions that final data won’t be in for at least a year. So don’t pull your hair out waiting for results. "

http://www.xconomy.com/2008/01/04/gone-today-hair-tomorrow-follica-raises-funds-to-begin-human-trial-of-baldness-treatment/2

NOTE: As I mentioned in another reply, there is NO such thing as skipping trials. They will have to go through the trials to establish the safety & efficacy before marketing it. They probably would use the trial data from trial(s) this year and submit it to FDA as well. And since Follica will probably get classified as a cosmetic procedure, the durations of trials will be shorter too. So if Follica does indeed work well, then I can guarantee you that this procedure will be in market within next 2 years.


#3

Ok, you may be right. I do not give it a big chances personally (for various reasons, xconomy is marketing server, marketing is always about best case scenarios (even though their chances were next to nothing), even in the article Zohnar is quoted to say that it will need several phases and so on).

But hopefuly I’m wrong as I do hate being bald as well.


#4

its good that you are critical with it. i think the same way like you. its not that easy. minoxidil was a proven pill (loniten) before and yet it had to be approved for external use. same with the minoxidil foam. its just another form of minoxidil, yet it had to be approved again.

i think the same way for follica. what could be though, is that some doctors do this procedure…without approval. there were even people using minox before it was approved, same with fin.

i think bostonbaldy was it who wanted to try the follica method himself. noone could forbid that to him. i wouldnt do it though, since its risky (what if you get cancer?).

the situation is the same like before with gho, bazan and intercytex. it looks good on paper, but it probably wont work that easy and that fast.


#5

» its just another form of minoxidil, yet it had to be approved again.

The difference is, the manufacturer specifically wanted to market minoxidil for another use. New drug applications are sometimes called marketing applications. A drug manufacturer can’t market a drug for a condition it’s not approved for (meaning no commercials, brochures, or sales teams pitching it to physicians – in other words, they can’t ramp up the big marketing machine to drive sales). The drug can still be used for other conditions by doctors, but unless the manufacturer has specific approval for a condition, it can’t market it for that condition. But they find sneaky ways around this, like presenting studies at medical conferences, which is a way of marketing it without really marketing it.

The bottom line is, Follica isn’t going to be selling these drugs as hair loss treatments. After all, by themselves, these drugs don’t even have an effect on MPB. Instead, they will be selling an abrasion procedure, of which these drugs enhance the results. Edit: I know this sounds like splitting hairs (pun intended, I guess), but it’s an important distinction. If they are not marketing the drugs per se, they wouldn’t need to get FDA approval.


#6

» » its just another form of minoxidil, yet it had to be approved again.
»
» The difference is, the manufacturer specifically wanted to market
» minoxidil for another use.

By the way, some of us (myself included) had finasteride prescribed to us before it was FDA approved for hair loss. I’ve also been prescribed dutasteride by a doctor, even though it’s not approved for hair loss. Docs are free to write prescriptions like this without FDA approval. What would be illegal, for example, is for Glaxo to start marketing dutasteride as a MPB treatment. In order to do that, they’d need to do the trials and get FDA approval. Otherwise, they can’t run commercials or push it on docs, etc.


#7

» I do not give it a big chances personally

Despite all this arguing, I actually agree with this. Most treatments fail to get to market. And given the complexity of hair growth and the past setbacks for things like HM, and you’d have to put the odds against Follica succeeding. But at this point I won’t be picky. I’ll take some odds over no odds at all.


#8

» » its just another form of minoxidil, yet it had to be approved again.
»
»

The maker made rogaine (minox) into a foam because they felt it would sell better as men already put mousse in their hair and its more cosmetically acceptable. They had to re-trial it to prove that this foam vehicle ACTUALLY WORKED like the liquid vehicle (mostly alchohol and Propylene Glycol) does.

I mean hell, if someone came out with a MINOXIDIL POWDER or Minoxidil SHAMPOO, it would have to pass the FDA trials to see IF IT ACTUALLY WORKED in order to be “FDA-Approved” for hairloss.

Did you know if you made a psoriasis cream into a psoriasis mousse, you’d also have to retrial with the FDA to get “FDA approval” for the mousse? Of course you would…they aren’t going to approve anything that doesnt show some efficacy.


#9

» Ok, you may be right. I do not give it a big chances personally (for
» various reasons, xconomy is marketing server, marketing is always about
» best case scenarios (even though their chances were next to nothing), even
» in the article Zohnar is quoted to say that it will need several phases and
» so on).
»
» But hopefuly I’m wrong as I do hate being bald as well.

I don’t know about your NW status, but I’m NW6 @ 26 and I HATE baldness…everyone that I meet (family, old friends etc) comments on it. Girls in this age group don’t prefer bald men either, period. It is quite hard for me to have somewhat of a normal life with this kind of severe hairloss. So i’m definitely desperate about hair, however, one thing I’ve learned from Intercytex experience is don’t listen to people saying something about upcoming big announcements etc etc and look at all the available information Realistically NOT pessimistically or optimistically!

As of trials, I forgot to mention ASCJ-9. Last year they did a three month phase-I, and now they are also done with phase-II, all within 1 year! They also filed an IND for ASCJ-9 foam topical for MPB and in Q4 this year they’ll proceed directly with phase-II trials for MPB.

This is a really good example of how things can go smoothly for follica too - if their trials show good results and excellent safety profile. As of ASCJ-9, they are pretty much flying through trials and since they also have mentioned that they’ll announce phase-II results in june along with a new website, i’m somewhat confident of good news from them. And if ASCJ as good as the studies say, it should be a really good and safe alternative to internal DHT inhibitors without the side effects


#10

I certainly hope for something better then just another propecia / rogaine


#11

» » » its just another form of minoxidil, yet it had to be approved again.
» »
» »
»
» The maker made rogaine (minox) into a foam because they felt it would sell
» better as men already put mousse in their hair and its more cosmetically
» acceptable. They had to re-trial it to prove that this
» foam vehicle ACTUALLY WORKED
like the liquid vehicle (mostly
» alchohol and Propylene Glycol) does.
»
» I mean hell, if someone came out with a MINOXIDIL POWDER or
» Minoxidil SHAMPOO, it would have to pass the FDA trials to see IF IT
» ACTUALLY WORKED in order to be “FDA-Approved” for
» hairloss.

»
»
» Did you know if you made a psoriasis cream into a psoriasis mousse, you’d
» also have to retrial with the FDA to get “FDA approval” for the mousse? Of
» course you would…they aren’t going to approve anything that
» doesnt show some efficacy.

but after your logic, doesnt follica has to do the same thing? it must show to work, too…