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If Follica doesn\'t have to do trials for FDA


#1

why is it taking so long to start them? They shouldn’t have to be as formalized, right? Just enough to show that it works, so they can go forward with their business plan. Take a few guys, do the procedure, and see if it works. It’s been over a year (I’m sure longer) since they’ve talked about putting this out as a product. Why would it take that long to start a trial? They have the patent, and there should be no shortage of volunteers. I don’t understand why it would take over a year to organize a non-FDA trial.


#2

» Why would it take that long to start a trial?

Because there’s a ton of preparation involved. Clinical trials are time consuming – from finding the funding, to designing a specific protocol, from doing all the paperwork, to finding and screening study subjects, to setting up the logistics for performing the procedures and doing the followups, etc. And that doesn’t even count the work that needs to be done after the trial. Why do you think it takes so long for new drugs to get to market (the average is about a decade, and only about 10 months of that comes from the FDA review)?

As an aside, Follica recently said (via Daphne) that they are doing a rigorous scientific study – not some flying by seat-of-the-pants study. If you want a study that’s going to be taken seriously, whether it’s for the FDA or not (tons of studies are published in medical journals that have nothing to do with the FDA), than you need to put in the effort to have a well-designed and executed study.

BTW, They only recently got funding for the human trial (several months ago, I think.)


#3

» why is it taking so long to start them? They shouldn’t have to be as
» formalized, right? Just enough to show that it works, so they can go
» forward with their business plan. Take a few guys, do the procedure, and
» see if it works. It’s been over a year (I’m sure longer) since they’ve
» talked about putting this out as a product. Why would it take that long to
» start a trial? They have the patent, and there should be no shortage of
» volunteers. I don’t understand why it would take over a year to organize a
» non-FDA trial.
short answer. protocols & preparation.

I believe the wounds on mice were 5mm deep; that’s an unacceptable amount on humans. I hate to speculate, but I suspect they’re evaluating several renditions of the process: variations of the compounds, dermabrasion depth, etc… before they start trials,

.


#4

Umm, I thought the wounds were like 2mm WIDE, not 5mm deep?

Was it both of those numbers or something?


#5

» Umm, I thought the wounds were like 2mm WIDE, not 5mm deep?
»
» Was it both of those numbers or something?

I think that is a mistake in the article. The used a felt-tipped wheel in the experiments with the mice and human skin and didn’t even make the animal’s bleed. Dermabrasion doesnt go that deep. We’d be bleedingn alot if they took off five millimeters of skin. That might be an “on-purpose” mistake. I honestly think Follica is more worried about bald doctors (who can get all the ingredients in the patent) trying this at home than anything, and then posting their results on the web. The people at Follica were probably suprised at the amount of responses that they have had and the intensity of the interest.


#6

» mistake. I honestly think Follica is more worried about bald doctors (who
» can get all the ingredients in the patent) trying this at home than
» anything, and then posting their results on the web. The people at Follica
» were probably suprised at the amount of responses that they have had and
» the intensity of the interest.

Thats exactly what I was thinking about, Follica is really spooked out by the response they got and people willing to go through the patent and possibly try it themselves. Thats why Daphne Zohar posted a message on another site basically telling everyone to relax/wait and that they are working on it. For this same reason, I’m quite sure Follica will be extra secretive about their trials (and results) too even if the results are good. They now know that the patent is out there and if the results are good people would just start trying it at home since the DIY dermabrasion/chemical peel kits are already available in the market.

Personally, I think Follica doesn’t really need worry about it though, because there are very few people competent enough to actually try it at home, the rest are just too lazy to try something like this at home and will just wait it out. Unless someone achieves a head full of hair at home, posts before/after pics online and gets everyone pumped up - but there is almost zero chance of that.


#7

» Umm, I thought the wounds were like 2mm WIDE, not 5mm deep?
»
» Was it both of those numbers or something?

The key with Follica’s procedure is that they are causing the stem cells in the epidermis to turn into hair follicles and 5mm is tooo deep for that purpose. I’d say the epidermis on the scalp is around 0.75mm-1mm (I googled but couldn’t find exact depth). So the only thing they need to remove is partial or full epidermis and there should be no blood but pinkish skin(only if they remove all epidermis).


#8

» » Umm, I thought the wounds were like 2mm WIDE, not 5mm deep?
» »
» » Was it both of those numbers or something?
»
» The key with Follica’s procedure is that they are causing the stem cells
» in the epidermis to turn into hair follicles and 5mm is tooo deep for that
» purpose. I’d say the epidermis on the scalp is around 0.75mm-1mm (I googled
» but couldn’t find exact depth). So the only thing they need to remove is
» partial or full epidermis and there should be no blood but pinkish
» skin(only if they remove all epidermis).

Again if they are removing just stratum corneum then you can also do it at home with kits. For the removal of entire epidermis you’d have to go to a dermatologist.


#9

» Umm, I thought the wounds were like 2mm WIDE, not 5mm deep?
»
» Was it both of those numbers or something?
I can’t remember where I read 5mm for the life of me, but you’re right of course; 5mm would go half-way through the poor mouse…

.


#10

The only question is whether this is an accidental or intentional miscommunication of their intentions. No way in hell they’re expecting to take 5mm off the scalp of a human in the real thing.

Half a centimeter of skin removed from the entire balding area . . . sh*t, you might as well just let some primitive tribal warrior scalp you with a tomahawk.


#11

It’s normal that science takes long time. Scientists (in contrast to ourselves here on this forum) are rational people.

» Take a few guys, do the procedure, and
» see if it works. It’s been over a year (I’m sure longer) since they’ve
» talked about putting this out as a product. Why would it take that long to
» start a trial?

Take a few guys, screw up with them, and your company and career ends. You are going to be sued till the end of your life.


#12

I’m not disagreeing with you about the need for them to take serious precations.

But it occurs to me that this stuff would have probably already been known to damage people if it was possible. It probably wouldn’t take much more than an arthritic guy scraping his head on something if it was gonna happen.

Heck, if we’re talking about possible DANGERS involved in the combination of the medications & skin regeneration processes, then the problems would probably have shown up anywhere any patient on the meds ever injured his skin. Not just on balded scalp skin in particular. It would be pretty hard for something like this to have gone unnoticed for years.