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Even 5 years for Follica\'s market lauch looks way to optimistic


#1
  • Pre clinical (animal studies etc)
  • IND granted
  • Phase I-III trials
  • NDA Granted by FDA

Now, it seems Follica is still doing the pre clinical at Harvard (response of human skin to disruption). Although, they have some investigators and sponsers for IND grants, it will still be another year or 2 to reach to phase I.

even if we assume everything goes perfect (which usually never happens), it will still be 5 years away.

Even 5 years from market launching looks way too optimistic.

And dont forget, when it comes out Bruce Willis is on the first line, not us.


#2

topic such this are USELESS, post only FACTS please


#3

Thanks for that Nostradamus, This is exactly what we need another post based on guess work.

As far as i know there isn’t one person on this message board who works for either Follica or the FDA, Yet there are countless posts rambling on about things that nobody can give a real answer to, Whats the point.


#4

it’s better than write useless things like this! Follica use medicines already approved, so all kind of prevision are false, nobody can know how they want go on with the work, and how many time this can need…


#5

» it’s better than write useless things like this! Follica use medicines
» already approved, so all kind of prevision are false, nobody can know how
» they want go on with the work, and how many time this can need…

Where is everyone getting all this BS from…they were on TV…the TODAY show…They have something that really works…No other hair loss research clinic lab or whatever so far has been on that…So im feeling pretty optimistic they have sometihing good. they said in 2-3 yrs they will have something out in themarket…they dont have to do clinical trials cuz everything they have done is safe…iuts just dermabrasion, some exisitng medications and lotions and what not…I think it will be a treatment not a cure…it will def cover our heads full of hair…Teenage density i dont know about that…but if it is that would be AWESOME!!! 5 yeard from now for a release i think it will be sooner…i think in 2010 we will have something really good out…my opinion…


#6

Here’s maybe an interesting thought for discussion along these topic lines:

How long are the patents good for and how could this impact the motivation/schedule?


#7

» - Pre clinical (animal studies etc)

Already been done by Follica. Don’t forget, Cotsarelis has been working on this for a couple of years already.

» - IND granted

Takes 30 days.

» - Phase I-III trials

They won’t have to do Phase 1, which are safety trials. The drugs in question have already been through Phase 1, and have mountains of data on the record. That’s the big advantage of using an already-approved drug. I am guessing they will do 1 or 2 trials after the current trial (probably 2).

» - NDA Granted by FDA

For drugs, it takes about 10 months, on average. But it’s worth repeating: Follica is not marketing drugs. This is a medical procedure, of which the drug is part of. So, their procedure may fall under a gray area, and it’s unclear what kind of approval they need.

» it will still be 5 years away.

The timeline totally depends on the path Follica is going to take, which they haven’t divulged yet. A Phase 2 trial would probably last 6 months. Phase 3, 12 months. Approval, 10 months. That’s 28 months total (2.5 years), but that’s not including the time between trials. Hell, a phase 2 trial wouldn’t even start for another 6-12 months. Then there’s probably another 6-12 months between the Phase 2 end and the Phase 3 start, and at least several more months after that before they present data to the FDA.

So, you are looking at least 4-5 years if they have to go through all the FDA hoops. Let’s wait for Follica to tell us how they are going to proceed.


#8

the thing that sucks is I don’t think follica wants to tell anyone their plan. They are increasingly secretive about their work. The only thing they will tell the media is when they have raised funds. I’m confused as to why they need to tell the media this since they are a privately held company…


#9

» the thing that sucks is I don’t think follica wants to tell anyone their
» plan. They are increasingly secretive about their work. The only thing they
» will tell the media is when they have raised funds. I’m confused as to why
» they need to tell the media this since they are a privately held company…

They are keeping it quiet cuz they have something good and want to be the first to bring a real working treatment…i was in Europe last may and they were talking about Cotsarelis and his work…It was on TV shows…i mean he is a legit scientist and so is his company…i mean he popped out of nowhere a few months ago and gave us this news…he might do it again in 2 years and say guess what guys it will bein the market in 4 months…we are common people…we dont know jack about a treatment that will be very revolutioanry…i remember watching a video clip of cotsarelis 7 years ago…he was like, there will be no real working treatment until 2010…i think he was hinting at soemthing there…and on the today show he say 2-3 years this follica can reach the market…so thats 2010-2011…hopefuly he wont make it longer…i want my hair back!!!


#10

Is it safe,thats Follica workes?


#11

» » it’s better than write useless things like this! Follica use medicines
» » already approved, so all kind of prevision are false, nobody can know
» how
» » they want go on with the work, and how many time this can need…
»
» Where is everyone getting all this BS from…they were on TV…the TODAY
» show…They have something that really works…No other hair loss research
» clinic lab or whatever so far has been on that…So im feeling pretty
» optimistic they have sometihing good. they said in 2-3 yrs they will have
» something out in themarket…they dont have to do clinical trials cuz
» everything they have done is safe…iuts just dermabrasion, some exisitng
» medications and lotions and what not…I think it will be a treatment not
» a cure…it will def cover our heads full of hair…Teenage density i dont
» know about that…but if it is that would be AWESOME!!! 5 yeard from now
» for a release i think it will be sooner…i think in 2010 we will have
» something really good out…my opinion…

Debris … if you read this, this is what you call naive or optimist ?


#12

» the thing that sucks is I don’t think follica wants to tell anyone their
» plan. They are increasingly secretive about their work.

From a business point of view, you can’t really blame them. There are at least a dozen ‘armchair scientists’ trying to unlock their secrets. :slight_smile:


#13

I agree with some of what you said there, but ive been doing a lot of reading about clinical trials recently to try and gain a better understanding of what they may need to do.

Its highly unlikely that they will be able to miss out phase I altogether, however it will be much faster as the data from the drugs previous aproval is taken into account, but not soley based on this.

While they have done the bulk of the pre clinical work with cotsarelis mouse studies, the current research study is described by Zohar as an investigator-sponsored trial, which is part of the IND process. Which would sudgest that they haven’t yet been designated IND status.
Which would leave them unable to test their drugs untill they do so, however no human data is needed for an IND, so they have already applied using pre-clinical data or are close.

I disagree with you when you say it will fall into a grey are because they are marketing a procedure and not drugs, I wont go into too much detail but a drug is a drug regardless of whether it is part of a procedure or not, they will also have to show the safety of the drugs in combination.
It is already pretty much comfirmed that they will need an NDA (Which is FDA approval).
What they haven’t told us is how long exactly they intend to spend on each phase.

Your right though, we need to stop speculating and wait for follica to tell us, as nobody can be certain untill then.
They seem pretty confident that they will have a viable product, and want to sell it to us asap.
Zohar says data from the current trial wont be in for at least a year, so I guess we will know more then.

Just for reference, here’s pretty much the only information we have regarding time lines;

http://www.helixis.com/news_events/2008/START-UP_Alist.pdf
“Folica, which licensed the technology from the University of Pennsylvania school of medecine, will begin human trials this year. If the results are positive, the company could be positioned to file for an Investigational New Drug Application in two or three years, Zohar says”


“Right now their money is funding a small human study which Zohar describes as “more of an investigator-sponsored trial.” And the company has enough money to push the program through proof-of-concept toward an NDA - a path that’s likely to take an accelerated development path that compresses the usual early and mid-stage trials into a 24- to 36-month window. An approval could conceivably be won in four to five years.

“What’s nice about it,” she adds, “is that even though this is based on breakthrough science, we are using existing compounds previously approved for systemic chronic use and reformulating them for topical acute use. We know these compounds are safe in people.”"


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.”


“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.”

http://stemcellbaldnesscures.com/follica/follica-takes-in-11-million-for-baldness-treatment-approach/
“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 (and an Xconomist)."

Dr George Cotsarelis - MSNBC Video
"If everything goes perfectly, it’s possible that within a few years we’ll have something that is available as a new treatment."

Nancy Snyderman - MSNBC Video
"We are going to have to see human trials which will be in the next year or 2. And I wouldn’t be surprised if this uh, didn’t turn out to be on the market in the next 3-4 years, maybe even sooner."


#14

» » the thing that sucks is I don’t think follica wants to tell anyone their
» » plan. They are increasingly secretive about their work. The only thing
» they
» » will tell the media is when they have raised funds. I’m confused as to
» why
» » they need to tell the media this since they are a privately held
» company…
»
» They are keeping it quiet cuz they have something good and want to be the
» first to bring a real working treatment…i was in Europe last may and they
» were talking about Cotsarelis and his work…It was on TV shows…i mean he
» is a legit scientist and so is his company…i mean he popped out of
» nowhere a few months ago and gave us this news…he might do it again in 2
» years and say guess what guys it will bein the market in 4 months…we are
» common people…we dont know jack about a treatment that will be very
» revolutioanry…i remember watching a video clip of cotsarelis 7 years
» ago…he was like, there will be no real working treatment until 2010…i
» think he was hinting at soemthing there…and on the today show he say 2-3
» years this follica can reach the market…so thats 2010-2011…hopefuly he
» wont make it longer…i want my hair back!!!

Perhaps I’m mistaken, but I was under the impression that he only discovered this phenomenon one or two years back?


#15

» - Pre clinical (animal studies etc)
» - IND granted
» - Phase I-III trials
» - NDA Granted by FDA
»
» Now, it seems Follica is still doing the pre clinical at Harvard (response
» of human skin to disruption). Although, they have some investigators and
» sponsers for IND grants, it will still be another year or 2 to reach to
» phase I.
»
» even if we assume everything goes perfect (which usually
» never happens), it will still be 5 years away.
»
» Even 5 years from market launching looks way too optimistic.
»
» And dont forget, when it comes out Bruce Willis is on the first line, not
» us.

Imho its quite obvious (the same way it was obvious many times before about other treatments) that omgIamBald is right. It wont take less then 5 years, and 5 years is pretty damn optimistic.

If they were going to use already approved drugs they would not even bother with IND. But for obvious (commercial) reasons they won’t use just existing drugs and thus they won’t avoid trials. Their goal is to make huge profits.

Imagine you got full head of hair, and you are a CEO of follica. And you want to make money. If you really manage to get rational thoughts about what to do in such a situation (unafected by your current hairloss, anxiety & desperation), you will get a nice and accurate picture of what is going to happen in Follica. You will come up with something like this:

  • in order to be able to make money, they will need a product they can control, and no unauthorised person or company can manufacture.

  • this is the way they will be able to set price on that product and make profits and avoid anyone from stealing from their invention.

  • a procedure is not such a product, anyone can do a procedure, all you have to do is just not tell anyone. There is no way Follica could stop any doctor doing it if it was just approved drugs. All that would have to happen would be that the doctor would not tell anyone, and if sued (very unlikely because there would be tenths or even hundreds of thousands of such doctors that occasionally would not use Follicas package but quietly without even telling the patient would substitute it with gefinitib and other drugs, and thus would avoid paying Follica the fee), would claim “I have used follicas packages always.” or if there was an evidence he actually never used follica’s stuff and was selling the procedure in a black market he could always say: “I didn’t know that the patient is on the drugs, I did just dermabrassion!!”. Trials would take ages, and there would be tons of them.

  • a proprietary drug is much better product, its hard to be manufactured by amateurs, and quite hard to be manufactured by professionals. And even if one or few companies managed to manufacture it and started doing so, you have straightforward weapons to protect yourself. You just call customs, they seize the stuff because it will be illegal, and they will shut down any factory thats producing it. Job done.

  • this logic was dictating that trials will be needed (even back at times when optimistic trolls here were saying the opposite and all this based on no evidence other then their desperation), the trials will take time, and 5 years is very optimistic time frame for a trial. Especially when they have not even started phase I yet. They are still in preclinicals. I am not aware of any other trial that would get the job done in such a time frame.


#16

» » » it’s better than write useless things like this! Follica use medicines
» » » already approved, so all kind of prevision are false, nobody can know
» » how
» » » they want go on with the work, and how many time this can need…
» »
» » Where is everyone getting all this BS from…they were on TV…the TODAY
» » show…They have something that really works…No other hair loss
» research
» » clinic lab or whatever so far has been on that…So im feeling pretty
» » optimistic they have sometihing good. they said in 2-3 yrs they will
» have
» » something out in themarket…they dont have to do clinical trials cuz
» » everything they have done is safe…iuts just dermabrasion, some
» exisitng
» » medications and lotions and what not…I think it will be a treatment
» not
» » a cure…it will def cover our heads full of hair…Teenage density i
» dont
» » know about that…but if it is that would be AWESOME!!! 5 yeard from
» now
» » for a release i think it will be sooner…i think in 2010 we will have
» » something really good out…my opinion…
»
» Debris … if you read this, this is what you call naive or optimist ?

Naive optimist? No way man. This guy is so much worse.

To be honest, it sounds more like a “lobotomy got wrong” to me.

He saw it on tv (then he says its the first time some hair loss research talk was on tv, which is a clear lie) and thus he made an assumption that in one and half or max 2 years from now on, the treatment will give full coverage (maybe not teenage density, but full coverage), even though trials take usually a decade and most of them are canceled and the product never reaches the market (for safety, financial, or efficiency reasons mostly). Even follica now admits that their goal is trials, but all that that guy needs to think the opposite is his “feeling” and naive assumption that follica can start buying gefinitib (a drug that has some very serious sideeffects, like a permanent & irreversible damage to your lungs) in pharmacies all over the country, package it together with dermaroller & lithium batteries in a pizza box and force every doctor to pay them licensing fees for using this package.

This sounds very rational and logical. Doesn’t it?

PS: I apologize for being rant, but could not resist :smiley:


#17

At this present time, saying follica will take longer than five years because they need to produce a drug from scratch is as naive mjones posts.

Look at the quotes I posted above.

Follica, from day one said they would need trials, what they were saying was that they would be shorter.
For example, phase I is a safety trial. The drugs that they are using are already approved for safety. Although this doesn’t mean follica mis out on a safety trial, they can be much shorter, as the previous data is taken into account.

Your arguments for them NEEDING to create a drug from scratch is ridiculous. For example, how do you know that, even using previously approved drugs, it will be so easy to replicate?
Follica may never tell us the exact combination or amount of drugs in their topical.
They may use laser dermabrasion, good luck finding a Dr with the skill to use a medical laser that would be willing to do it to replicate follica.
Their ‘kits’ will likely be licensed to certain dr’s and dermatologists only.
It would take them a decade + to develop a new drug and millions and millions of dollars
In the mean time they would be losing out on money because they could have a product on the market being sold, using existing products.

You have a vivid imagination :slight_smile:


#18

I can assure you they will either license gefinitib or create their own from scratch. Considering benefits of their proprietary drug, and likehood that even licensed gefinitib would have to be trialed (topically) to prove safety and exclude the possibility of lung damage, I am pretty sure they will do their own EGF inhibitor.

And the theory of not revealing exact components is ridiculous … there is no way any medical treatment or drug being sold legally without proper specification of the drug.

Can you name at least one other medical drug thats not listing ingredients? At least a single one? lol.

Sometimes I got a feeling that this forum is full of guys who have been hiding in their homes with caps on their heads 24/7 so that they have lost all their connection with reality.


#19

» I can assure you they will either license gefinitib or create their own
» from scratch. Considering benefits of their proprietary drug,

The company has 4 friggin’ employees, and a shoestring budget. They don’t have the expertise, the time (10 years), money (hundreds of millions of dollars), or any other resources to synthesize and test a new drug. Christ, they are not a drug company.

» I am pretty sure they will do their own EGF inhibitor.

How do you propose they do that? With what people and what money? Not to mention, THEY ALREADY SAID THEY ARE USING EXISTING DRUGS. Are you dense, debris? No offense, of course. :smiley:


#20

» For example, phase I is a safety trial. The drugs that they are using are
» already approved for safety. Although this doesn’t mean follica mis out on
» a safety trial, they can be much shorter, as the previous data is taken
» into account.

I agree, but in my opinion, there won’t be a specific trial for safety alone – instead, they will monitor for side-effects during trials, perform blood tests to detect the level of absorption of the drug when it’s applied topically, etc. If their next human trial is abrasion + drugs, then we know this is the case.

I’m not even sure that it makes sense to do a separate trial for just the drug alone – even if it proves safe, it would be still have to be proven safe with abrasion (since compromised skin significantly increases drug absorption). So, a trial without abrasion doesn’t mean it’s safe. You need to test them in tandem, which is to say you are testing their whole procedure.

Also, the drug is applied topically for probably at most 7 days. They could do a safety trial in no time at all if they wanted.