First I think they never said that they will not require trials but at the most they just mentioned a hope that they might not. Which is a bit different thing and is something that is logical to claim from someone who needs funding and whose funding depends on success and the time it can be acheived.
» I yet to have to see a precedent for applying drug into a wound with an
» intention to trigger neogenesis and grow new organs & tissue completely out
» of nothing. And follica as far as I know claim new follicles, not reviving
» or increasing thickness of existing ones. They say that this wounding +
» drug creates new follicles where nothing has been before. I seriously doubt
» that FDA will just tolerate that without trials.
Your usage of word organ is quite dodgy, you make it sound like its a heart, a kidney or some other very complex organ that survival is dependent on. FDA has easily approved lasers that destroy the same organ you’re talking about, FDA has also easily approved so many chemicals that peel way the skin (the largest organ) and cause it to regenerate (new growth). FDA isn’t run by idiots, they understand the difference between skin, hair, heart, kidney, liver etc etc, so they formulate policies accordingly, at the end, Follica’s work may end up being classified as a cosmetic procedure, which means that the path to commercialization gets even easier.
» I yet to have to see a precedent for applying drug into a wound with an
» intention to trigger neogenesis and grow new organs & tissue completely out
» of nothing.
I have seen something that does almost that – phenytoin. It’s a great wound healing agent. It’s approved in oral form for epilepsy. It has a ton of side-effects, some very serious, and is fatal in not that big of a dose. Yet, it’s applied TOPICALLY to gaping, bloody wounds in an amount that would put a person in a hospital or a morgue if they took it orally. And it re-generates skin very well. Some docs use it for this purpose. Search Pubmed for phenytoin and wounds.
I seriously doubt that FDA will just tolerate that without trials.
It’s not for you to decide. Follica says they don’t need trials. For the past 2 years, they’ve been writing patents, starting a company, gathering funds, and doing pre-clinical work. I think they would also research this, don’t ya think? So, you are asserting one of two things:
- Follica is making a bold-faced lie when they say they don’t approval.
- They are completely and utterly incompetent businessmen, having not even researched what it would take to bring their product to market.
Which one is it, buddy?
» FDA has easily approved lasers that destroy the same organ you’re
» talking about, FDA has also easily approved so many chemicals that peel way
» the skin (the largest organ) and cause it to regenerate (new growth).
And some agents haven’t had any approval at all for this purpose. But they are used, anyway.
Please send me a link to that folica claim that trials are not needed if you have it. Ta.
Does it even exist?
Debris, I’m not gonna debate the topical situation with you because I don’t really know how that’s gonna shake out.
But the situation with INTERNAL meds for the Follica method seems pretty damn cut & dried. If the meds work internally, then I can see no possible way for the FDA not to approve the Follica deal that way.
There is no functional difference between doing the Follica method (at least with internal-only meds), versus just taking the same internal meds like a doctor ordered and then accidentally getting a cut on your head during everyday life. No functional difference at all.
Either the (internal-meds) Follica deal is allowed, or else the FDA yanks all these existing drugs off the market across the board. It’s that simple.
» Please send me a link to that folica claim that trials are not needed if
» you have it. Ta.
»
» Does it even exist?
Debris I think your just being flippant and pedantic, you know as well as the rest of us that it doesn’t say anywhere that Folica will not need trials or even not need FDA approval, just that the trials would be a lot shorter and approval not very difficult…
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.
This is the only written account (On the Internet) I’m aware of, of someone from Folica talking about the trials and regulatory process.
You could say that this was written by someone that has no Idea about follica, its made up, it’s marketing, whatever, but Daphne Zohar has taken the time to post on that site herself (Separate to the main article, and she hasn’t posted anywhere else on the net) and has not corrected anything, so you could say that this info is kind of official.
More and more discussions are concentrating (with obvious reasons) around FDA/testing time related issues. Would the situation be different in other countries, i.e. less than 10 years testing required for approval say in India?
I mean, if Follica(or Intercytex/Aderans/whoeverComeWithAFeckingWorkingProduct), following debris theory (“worst case scenario”), needs those 10 years why wouldn’t they release their product as soon as it works first in other markets where testing would be faster/minimal? From a financial perspective wouldn’t it make more sense?