These article shows that Follica doesn’t need to go through 1/2/3 clinical trials. They have show that this drug, already approved for a specific purpose, can be useful for another purpose (hair growth): so they can promote and commercialize their own treatment.
» These article shows that Follica doesn’t need to go through 1/2/3 clinical
» trials. They have show that this drug, already approved for a specific
» purpose, can be useful for another purpose (hair growth): so they can
» promote and commercialize their own treatment.
They HAVE to do a phase-0 (IND) trial…if thats good, then they may need to do either a phase-II (or phase-III) and that’s it. E.g. Rogaine Foam only had to go through Phase-II because the safety & profile of the drug was already established. And they just had to prove that it’s still as effective - hence phase-II only. Another example is Androscience, they did a phase-0/1/2 for ASCJ-9, so now that the safety/efficiacy profile has been established, they just filed a IND for ASCJ-9 foam and are proceeding directly to phase-II.
There is no need for Follica to go through 3+ years of testing for already approved drugs.
Folica could probably skip phase#1 with this logic but that still leaves #2 and #3.
Honestly I don’t see how they could publish a good result from phase#2 without people starting to do this on their own. Phase#2 tells people that it works and it includes enough specifics to copy it. From that point, it would REALLY only be a matter of throwing some money at it to do the job yourself at home.
» Honestly I don’t see how they could publish a good result from phase#2
» without people starting to do this on their own. Phase#2 tells people that
» it works and it includes enough specifics to copy it. From that point, it
» would REALLY only be a matter of throwing some money at it to do the job
» yourself at home.
Yup, I think their primary business model would be selling “kits” or licensing the procedure to the dermatologists. They probably know that most of the people would rather have a dermatologist dermabrade their scalp then they do it themselves. Just like automotive repair, people can do a lot of it themselves but most don’t.
Most of the people on this hairloss forums are desparate, and willing to try this before commercialization. So the market loss for Follica is minimal.
Follica will not use already approved drugs. They wont because investors will force them not to. They will add something so they can patent it and have monopoly on its manufacturing. They will want to go through trials for these very logical reasons.
FDA also for their very own reasons (financial mostly) will want them to go through trials.
Both parties involved will want trials. and these will happen. All of them. That is assuming it actually works which is totaly different topic.
»
» http://www.hhs.gov/asl/testify/t960912a.html
»
» These article shows that Follica doesn’t need to go through 1/2/3 clinical
» trials. They have show that this drug, already approved for a specific
» purpose, can be useful for another purpose (hair growth): so they can
» promote and commercialize their own treatment.
They could but they won’t. They will not for the same reasons natural products are never being pushed by pharmas to the market. No private company will ever investigate and spend money on something someone else is manufacturing and selling because it would mean the someone else would be profiting of their research, not them.
Its going to be 2010 and you and me are still going to be bald. This is almost certain. The chances we won’t are the same as chances that someone will out of nowhere find out that honey, regrows all your hair back.
Follica will not use already approved drugs. They wont because investors will force them not to. They will add something so they can patent it and have monopoly on its manufacturing.>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>YES….E TO LEAVE THE COMPETITION TO LAUNCH SOMETHING IN ITS FRONT? HOW FOR EXAMPLE INTERCYTEX IN 2011 2012? OR ALSO ADERANS? HM COME OF INDIA? OR WHO KNOWS ACELL? I DO NOT SEE GREAT PROFITS IN THIS.
you are naive. there is virtually no serious competition. no one has so far found anything that would grow hair back on slick bald heads. most of drugs regrow a bit and maintain others do nothing.
Follica have nothing to be afraid off, they know that most probably out of the few competitors they have, most of them are going to disapoint / fail and for the rest it is going to take ages to pass trials.
What is absolutely certain is that they will not spend millions of dollars on research of something that anyone could manufacture.
I’ve found some clinical studies that honey is good for neutralizing micotoxins. There is some evidence that fungal infections and hairloss are connected.
Now why I’m bringing this ridiculous thing up. I maintain and regrow because I use a lot of stuff. Though, I always have been the guy who kinda sheds a lot no matter what he does. I’m on fin so the hair keeps growing back, but still daily hair count I shed was used to be rather high.
Recently I started experimenting with vitamin B complex and ZMA and magnesium, to try to make the environment for fungal infections in my body a bit more tough.
It seemed to help. Then I fond the study on micotoxins and honey. I’m testing it few weeks now, and of course I have no clue if its just the honey, but If I take some, I hardly shed any hair.
I am naive, and you a pessimist convicto. I do not understand as companies who pass years studying and showing reports for its shareholders she does not have nothing.I also do not understand companies as follica and aderans publishes comes it and divulges discovered on one FUTURE cure of calvicie, without having nothing in mind. It never mentioned that already the cure for calvicie exists, but I say that they are in the certain way for this, but always PESSIMISTIC you as, come here and contradict everything that appears of new information. what you it wants debris? what all the companhis among others… follica intercytex aderans that they silence the mouth and they close the doors?
» I think you are missing point.
»
» Follica will not use already approved drugs. They wont because investors
» will force them not to. They will add something so they can patent it and
» have monopoly on its manufacturing. They will want to go through trials for
» these very logical reasons.
»
» FDA also for their very own reasons (financial mostly) will want them to
» go through trials.
Please tell which drug in their patent is not already FDA approved??? If you think follica will invent a drug to use in this procedure…then you are just out of your mind.
As of securying IP, just as there are patents for hair growth using various herbs etc…all Follica wants is to secure the way(procedure) for regrowing hair. They are NOT a pharmaceutical.
They have stated publicly that they are going to do exactly that.
They wont because investors will force them not to. They will add
something so they can patent it and have monopoly on its manufacturing.
Their procedure is already patented.
To develop a new drug from scratch, and then run it through all the trials and approval process, is easily 10 years worth of work and hundreds of millions of dollars in cost. There is almost no way in hell they will opt for this choice.
Based on Follica’ comments, we can infer they are using existing, approved drugs. In fact, given that human trials are set to begin, they are indeed using already existing drugs (if they had to develop something from scratch, it would be years before they could even begin human trials).
They will not for the same reasons natural products are never being pushed
by pharmas to the market.
You seem to not understand Follica’s procedure. They are not going to sell a drug to grow hair. This isn’t something like Rogaine or finasteride. They are performing a procedure – abrasion applied to the scalp, followed by 1 or more substances applied to the scalp to activate certain pathways. They can indeed get patent protection for this procedure.
Besides, what you are saying doesn’t make sense. You seem to think that developing a new drug would somehow better protect Follica. Using your logic, it wouldn’t, since knock-off artists would simply just use existing drugs in place of the new drug. But again, this isn’t a simple drug treatment, so the specific drug used is not what is important – the procedure as a whole is what is important, and Follica has a patent on that.
» » They could but they won’t.
»
» They will, and they are. They have said as such.
»
» > They will not for the same reasons natural products are never being
» pushed
» > by pharmas to the market.
»
» You seem to not understand Follica’s procedure. They are not going to sell
» a drug to grow hair. This isn’t something like Rogaine or finasteride. They
» are performing a procedure – abrasion applied to the scalp, followed by 1
» or more substances applied to the scalp to activate certain pathways. They
» can indeed get patent protection for this procedure.
»
» Besides, what you are saying doesn’t make sense. You seem to think that
» developing a new drug would somehow better protect Follica. Using your
» logic, it wouldn’t, since knock-off artists would simply just use existing
» drugs in place of the new drug. But again, this isn’t a simple drug
» treatment, so the specific drug used is not what is important – the
» procedure as a whole is what is important, and Follica has a patent on
» that.
Then we have already existing drugs and the procedure, which is in the patent, so what is left ?
» Then we have already existing drugs and the procedure, which is in the
» patent, so what is left ?
It’s the timming of the drugs they need to figure out to generate maximum hair growth. I’m sure they’re also looking for a way to rejuvenate existing hair, because it would be much more preferred by guys under 30 who still have loads of vellus hair on their heads.
Once protocls have been finalized, then Follica would probably proceed with first trial and so on.
I must admit I do not understand you much this time.
Follica Aderans and ICX are trying to find a treatment for baldness. I’m not saying that some of them won’t find it in the end. I just say that it will take years and that they will make sure it involves IP that is well protected and thats protection can be easily forced by law so that they had a monopoly on the whole thing.
Imagine you have patented procedure that involves drugs that exist.
What stops someone from buying the drugs off label and performing the procedure? Almost nothing. They can always claim they did not use your procedure and that all the regrowth is just their snake oils and these do not contain the drugs that patent mentions. They will never sell it never give it to anyone, they will just open up doors for guys, guys will walk in, they will buy the drugs off label, perform the procedure, get money, and leave no proof to anyone that they used your patented procedure.
Now Imagine that you’d develop a procedure that involves a drug only you can legaly manufacture and sell.
What stops someone from buying that drug? The fact that if someone was manufacturing and selling that drug, you can sue him and you are going to easily win. Of course there may be ppl who dont care (like chinese) but then you can always start spooking ppl with the fact that their drug is illegal and not pure enough and harmful. It just gives you much better position for law enforcement.
If you were follica CFO and not the balding poor guy you are, what would you do? Would you do trials that involve drugs that can be easily acquired by anyone? Or would you try to make it harder to copy?
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