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Off-label conundrum


#1

Follica may get their procedure to work but will still require regulatory approval. It’s what I think is called off-label use where a drug has approval for specific conditions but where it is used for a different, unlisted condition.

Apparently, the approval process for this extended use is less onerous than the original permission but what it means in terms on months or years I couldn’t say.

Individuals can order the substances and do what they like with them and even individual doctors can prescribe drugs for off-label use assuming sound judgment whatever that means. However, it is illegal to market or advertise off-label use of approved substances which complicates life for Follica.


#2

» Follica may get their procedure to work but will still require regulatory
» approval. It’s what I think is called off-label use where a drug has
» approval for specific conditions but where it is used for a different,
» unlisted condition.
»
» Apparently, the approval process for this extended use is less onerous
» than the original permission but what it means in terms on months or years
» I couldn’t say.
»
» Individuals can order the substances and do what they like with them and
» even individual doctors can prescribe drugs for off-label use assuming
» sound judgment whatever that means. However, it is illegal to market or
» advertise off-label use of approved substances which complicates life for
» Follica.

basically follica wont use off label drugs in their procedure, they will go through trials so they can control the drug and market it and sell it and make money on it.

Whole this off label use idea was dead from begining.


#3

» basically follica wont use off label drugs in their procedure, they will
» go through trials so they can control the drug and market

It is NOT a drug - It’s a Procedure! There is a big difference. They are not inventing or creating any drug either, they are using pre-approved drugs and will probably mix them together and that’s about it. The same way Dr. Lee or Dr. Proctor mix various drugs/chemicals and market it.


#4

They are not using the drugs to regrow hair. Take gefitinib for example. They are using it as an EGFR Inhibitor. It is already approved as a EGFR Inhibitor. I am sure some of this needs aprroval, but I dont think it will take as long as some people on this forum think. Then again, if it doesn’t work in humans, it doesn’t really matter what needs approved or what doesn’t.


#5

» » basically follica wont use off label drugs in their procedure, they will
» » go through trials so they can control the drug and market
»
» It is NOT a drug - It’s a Procedure! There is a big difference. They are
» not inventing or creating any drug either, they are using pre-approved
» drugs and will probably mix them together and that’s about it. The same way
» Dr. Lee or Dr. Proctor mix various drugs/chemicals and market it.

yes and in the last official announcement they said that they are now in a phase to develop technology to a state that it could go through regulatory approval procedures.

SO DREAM ON :slight_smile:


#6

» yes and in the last official announcement they said that they are now in a
» phase to develop technology to a state that it could go through regulatory
» approval procedures.
»
» SO DREAM ON :slight_smile:

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

“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 setence from the original article suggests otherwise. Still, no body knows for sure yet, they may indeed have to go through phase-I, II & III trials. However, by the end of phase-I, we should have a pretty good idea of their protocol and stuff. That way a lot of people on this forum would be able to do it at home, even though it may not be available in the market yet. Eventually, If Follica works, it would come down to how desperate you are to get your hair back.


#7

» » » basically follica wont use off label drugs in their procedure, they
» will
» » » go through trials so they can control the drug and market
» »
» » It is NOT a drug - It’s a Procedure! There is a big difference. They
» are
» » not inventing or creating any drug either, they are using pre-approved
» » drugs and will probably mix them together and that’s about it. The same
» way
» » Dr. Lee or Dr. Proctor mix various drugs/chemicals and market it.
»
» yes and in the last official announcement they said that they are now in a
» phase to develop technology to a state that it could go through regulatory
» approval procedures.
»
» SO DREAM ON :slight_smile:

That isn’t what they said, this is the only mention of regulatory approvals.This financing will enable us to build out the company and move well down the path towards [regulatory] approval,” says Daphne Zohar, managing director of PureTech Ventures.

This is also from the same article.With the regulatory path relatively clear, Follica’s plan was to use its Series A money to quickly begin a small proof of concept study, involving 15 to 20 patients. Zohar yesterday confirmed that a pilot study is underway but wouldn’t confirm where or give any other details on its timing other than to tacitly stick to the timeline she laid out in January, when she said that final data from the study would not be available for at least a year. “Everything is progressing on track,” she now says. “We are moving as quickly as possible within the constraints of clinically driven medicine.”.

Lets be honest here, Not one of us knows what drugs they will be using and when it will be released.


#8

» Lets be honest here, Not one of us knows what drugs they will be using and
» when it will be released.

In five years.

D’OH :stuck_out_tongue:


#9

» » Lets be honest here, Not one of us knows what drugs they will be using and
» when it will be released.

They tell you what drugs they will be using in the patent. Exactly which drugs as a matter of fact. They have a list of a class of drugs that inhibit epidermal growth factor. They will use one of these drugs. They will also use a channel opener from one of the three they have listed. They will use an antiandrogen out of one of the four or five they listed. They may have to use cyclosporin or another cytotoxic. If they do, they will likely have to use an antibiotic and anti-micribial. They might use a retinoid which is also in the patent. Thats about it as far as the patent goes.

It would be ILLEGAL for them to file for a patent and then try to include some other adjuvant later. By law, they have to use things in the patent. They can exclude some of them, but they cannot later add anything and the procedure still be patent-protected (meaning someone else could use it).

Frankly Im wondering if cyclosporin might be necessary for really great results. In human skin on immuno-deficient mice, just wounding alone produced hair-----which obviously would not happen very often in people.

There is no “secret” ingredient. The patent takes care of all of that.
»
»»


#10

» » » Lets be honest here, Not one of us knows what drugs they will be using
» and
» » when it will be released.
»
»
»
»
» They tell you what drugs they will be using in the patent. Exactly which
» drugs as a matter of fact. They have a list of a class of drugs that
» inhibit epidermal growth factor. They will use one of these drugs. They
» will also use a channel opener from one of the three they have listed. They
» will use an antiandrogen out of one of the four or five they listed. They
» may have to use cyclosporin or another cytotoxic. If they do, they will
» likely have to use an antibiotic and anti-micribial. They might use a
» retinoid which is also in the patent. Thats about it as far as the patent
» goes.
»
»
» It would be ILLEGAL for them to file for a patent and then try to include
» some other adjuvant later. By law, they have to use things in the patent.
» They can exclude some of them, but they cannot later add anything and the
» procedure still be patent-protected (meaning someone else could use it).
»
»
»
» Frankly Im wondering if cyclosporin might be necessary for really great
» results. In human skin on immuno-deficient mice, just wounding alone
» produced hair-----which obviously would not happen very often in people.
»
»
»
»
» There is no “secret” ingredient. The patent takes care of all of that.
» »
» »»

I know that it was all in the patent, But the amount of drugs they included in it was to stop people replicating their mix. I mean we all know what’s in a hamburger but i still can’t make them taste like McDonalds.


#11

you’re joking arent you?

ok its true they cant add anything to the patent. But they dont want to add anything to it. They issued it to prevent existing owners of the drugs to legally start their hair business. thats all.

Now if they develop a new drug, they have monopoly on it protected & enforced by FDA and no one can market or sell generic equivalents for a decade or so and thus have a full controll over pricing (they sell the drug and anyone can do the procedure, their fee is included in the price of the drug)

While if they use existing drug, someone else can market and sell existing drug and they cant. They cant control whose doing the procedures and they cant enforce license fees because they are not selling anything themselves to the doctors who perform the procedure.

development of a new drug is not illegal. the patent prevents the current owners and manufacturers of the existing drugs from starting their own hair business – thats a logical step. Next logical step is to either go with their own drug go through trials, gain FDA approval, market it, and have monopoly on its selling. Or alternatively, license one of the existing drugs from its actual owner. Whichever of these two options will look more lucrative to the investors.

First option - their own drug - harder trials but true monopoly on the procedure controlled through the drug sales and virtually no money leaking into someone elses pockets.

Second option - possibly faster approval, but substantial amount of revenues goes to someone else and whats worse, pricing of the drug has been already made. So while they can put it into a new box, and set the price super high, they will never be able to prevent doctors from using the existing drug name instead of the more expensive pockage and name brand marketed for hair regrowth. Result thus would be that for all the money they would spend on marketing they would get substantial amount of money ending in the other companys pocket for both the current and new name brands of the drug, and another bunch of money leaking into doctors pockets whenever the doc charges the patient full price but uses the cheaper version of the drug to fill a hole in his pocket. In the later case, follica would get no money at all. just doctor & the original owner of the drug would benefit.


#12

“I mean we all know what’s in a hamburger but i still can’t make them taste like McDonalds.”

True. If you’ve got half a brain and a grille to cook it on, it’ll probably taste better!


#13

» “I mean we all know what’s in a hamburger but i still can’t
» make them taste like McDonalds.”
»
» True. If you’ve got half a brain and a grille to cook it on, it’ll
» probably taste better!

You know what i’m talking about though:-P


#14

Yeah I know.

But I just don’t really care about Folica’s approval as long as this looks reasonably do-able at home. All the drugs are out there. Dermabrasion is easily available.

I just want my hair back badly enough to take matters into my own hands. I’m just not willing to spend another 5-10 years balding so the FDA can re-certify a bunch of preexisting drugs and Folica can nicely package this stuff.


#15

» Yeah I know.
»
»
» But I just don’t really care about Folica’s approval as long as this looks
» reasonably do-able at home. All the drugs are out there. Dermabrasion is
» easily available.
»
» I just want my hair back badly enough to take matters into my own hands.
» I’m just not willing to spend another 5-10 years balding so the FDA can
» re-certify a bunch of preexisting drugs and Folica can nicely package this
» stuff.

I feel the same and i really do think that in the next couple of years there will be a real and affordable treatment for hairloss, Science is moving really fast now and the understanding that they have gained over the last few years is amazing when you read it.


#16

Yeah, it’s been dramatic lately.

If I had the cash & situation lined up right now, I would probably get a more aggressive FUE session than I would have chosen to have done a couple of years ago.

I’m not ready to do the full-blown Armani “stuff the front & damn the consquences” HT yet, but the MPB research progress has been enough to really move my own comfort zone into more aggressive territory.

I’m also finding myself getting more lazy about my daily Finasteride dosages too. I haven’t dropped the stuff yet but I’m taking less of it than I have in a long time. Rightly or wrongly, my subconscious is just not worried about it as much anymore.