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not to sidetrack this tread, but I spoke to a Dr. Cooley rep and she asked me if I took fin and I told her that I took 1mg everyday. She immediately stated that was way too much and that it only needs to be taken at max 3 days a week. She stated it stays in your system for 72hrs. She recommended M/W/F for an easy schedule to keep. Dr. Cooley has an exceptional reputation so I'm sure that this is what he has found in his research and passed along to his rep. But since a low amount of fin(.25mg) suppresses almost as much as a normal dose(1mg), it seems safe to assume that taking .25mg 2-3 times a week would be the best balance to keep your hair and avoid sides. Thoughts?Comment
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I dont think it's a good idea to let your hormone levels fluctuate in this wayKiwi if you really wanna give it a shot and have had issues b4 try:
0.25mg EVERY 10 days for the first month, then
0.25mg EVERY 9 days for the second month, then
0.25mg EVERY 8 days for the third month, then
0.25mg EVERY 7 days for the fourth month, then
0.25mg EVERY 6 days for the fifth month.
Then just continue taking it every 6 days. This allows your body to produce some DHT between days 4-6 which should hopefully keep you mojo intact.
ATM, instead of every 4 days I'm trying every 6 days for the past 2 weeks see what happens. I'll keep you posted
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How about a good dosage/mix between being optimistic and also being realistic?
Just being too optimistic - the disappointment is mostly too big and can sometimes even have a destructive effect, if an individual is not prepared for any worst-case scenario.
Anyway - here is a dialoge between being rather irrational (jarjarbinx) and a good dosage/of being optimistic but also being REALISTIC (another user - not me):
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» I said new and better treatments will start hitting the market in months
» (bimatoprost) to 2 years. Experts said "less than 10 years" and I do
» believe that months to 2 years is "less than 10 years." So the
» experts are not contradicting what I'm saying. I'm saying within 2 years
» and they are saying within 10 years and 2 years is within 10 years.
Let's not start with self-obvious statements like "2 years are less than 10 years". The question is what usually happens around us with well-defined deadlines. You are probably aware that they are often missed or at best the products are delivered in the very end of the period. Why a vague deadline (10 years or so) for such a complex task, like safely multiplying hair and make it grow on a bare head, would not be missed?
» Experts don't want to sound overly optimistic. They're being needlessly
» over cautious.
Do not we hear the same thing for 10-15 years now, that the cure is 5 years away? And each new year the same thing all over again and still nothing? The experts are not needlessly cautious, they are realists.
» Why do you say this? The experts did NOT say that a cure will come in 10
» years; they said a cure will come WITHIN 10 years. That could mean
» tomorrow. Within 10 years means any amount of time inside of 10 years. The
» could mean months. It could mean a couple years. You don't have to take it
» all the way to the furthest possibility.
See my previous comments.
» Some of these new breakthrough treatments are going to be
» very good treatments. I can tell by their results so far.
And what is the evidence to support this opinion?
» I disagree. I think they have said that they are growing hair in all
» regions of the scalp.
If they succeeded growing new hair in completely bald skin, then the increase rate would be nearly infinite per cent. But it is not. It is a finite difference, meaning that there was already hair.
Look, I much want to believe but I don't see enough evidence.
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Exactly - where is the evidence?
... besides big numbers and lots of bold claims?
For example ...
Why bought this guy a hair transplant robot for his patients, when another individual of this team of a "hair stimulating complex" breakthrough claimed during a scientific meeting that their stuff is even able to grow hair in scar tissue??
So, am I pessimistic or realistic? Or am I simply just an idiot?Comment
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Look the reality is if you're above NW3 Histogen alone will not bring back your juvenile hairline...
Neither Histogen, Aderans nor Replicel will be able to do that...
Ppl will still undergo hair transplants...
These treatments will simply save the hair you have and cause a bit of regrowth...if you want a juvenile hairline, you will end up combining these cutting edge treatments with a transplant depending on how far your hair loss has progressed.
FUE, FUT, Gho, etc will continue to exist until Dr Lauster releases his hair multiplication which will be somewhere around 2020 if we're luckyComment
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You bring up a good point, but you could be making the assumption Histogen fails and then letting your conclusion about ARTAS flow from it, but look at it the other way.For example ...
Why bought this guy a hair transplant robot for his patients, when another individual of this team of a "hair stimulating complex" breakthrough claimed during a scientific meeting that their stuff is even able to grow hair in scar tissue??
So, am I pessimistic or realistic? Or am I simply just an idiot?
Lets assume Histogen works. What then? Well, I can already point to several ARTAS users that are making money like gang busters now so we know it makes sense for the HT doc as a business decision on it's own, but then lets say you have one of the next gen cures like Histogen or Aderans in hand and it can grow hair. Thats opens up whole new markets of hair transplant customers that are different from today's customers. They might not need as many grafts, but in any case, I wouldn't be surprised at all in the 2016 to 2021 timeframe if we see the companies with the cures moving most aggressively towards automation because these will already be the companies taking advantage of economies of scale.
And consider that this particular operation just hired a 3rd surgeon away form Bosley who sued them over it. They're not huge, but they're growing.Comment
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Hey Desmond,
Do you know what Aderans has going in Europe or say Australia?
Does FDA approval give you EU / UK / Australia / Japan approval or will Aderans be starting over with a multi year trials in EMEA?
Thanks!Comment
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Well I'm pretty sure they are planning on rolling out ji gami all over the world around the same time ie EU / UK / Japan / US / Australia.
I base this on the fact that they have been filing for patents in all these regions since 2002. Here's the link for their patent protection in Australia for example:
With regards to the Approval process, every region has their own INDEPENDENT regulatory approval body and they're all pretty strict!
TGA (Australia)
EMEA (Europe)
PMDA (Japan)
FDA (Europe)
On average most of these organisations take 10-15 months to process an application once Phase 3 is completed!
Some regulatory bodies prefer specific types of trials,, e.g.
EMEA (Europe) prefers comparing new drug against the current gold standard (i.e. Propecia), whereas
FDA (US) prefers comparing new drug against placebo in Phase 3!
while others such as TGA tend to follow EMEA!
So what a lot of companies do is they have 3 treatment arms in their trials: one using placebo, one using Propecia and one using Ji gami for example. This will keep all regulatory bodies happy.
Some companies though opt out for FDA approval first (placebo-controlled) and hope for the best with other regulatory bodies!
So in short, just because you got your product approved by FDA doesn't mean you can role out your treatment in Europe, Japan or Australia.
South Korea, Singapore, Hong Kong and Taiwan are a different story though. Their regulatory bodies have just recently formed and they seem to be quite laxed regarding drug approvals!Comment
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Yeah dude
if Lauster brings out Hair multiplication baldness is no longer a curse but a fashion statement LOL
But that's at least 7-8 years away (even longer to be honest)...
Lauster is where Aderans was back in 2002! So, in the mean time we really should root for these other treatments to save our hair at least for the next decade
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What's your view on Dr Nigams clalims on HM?Yeah dude if Lauster brings out Hair multiplication baldness is no longer a curse but a fashion statement LOL
But that's at least 7-8 years away (even longer to be honest)...
Lauster is where Aderans was back in 2002! So, in the mean time we really should root for these other treatments to save our hair at least for the next decadeComment
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So, if I heard you right, the approval process is separate in each country, but a company may have conducted trials in such a way to apply for approval simultaneously at all of them?
Desmond, I was thinking FDA likes to sit on the data about six months after completion, not 10 to 15, but that was just my second hand opinion. I know you've written some of this before, but what exactly is the cadence in your mind for the next 2 years besides the 12 month trial part?
Does it take time to design/submit a phase 3 trial before you start?
Is it normal to spend time before getting approval on commercialization?
Thanks!Comment
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I'll be honest with you BB, there's no way in hell I'd fly to India to undergo any operation!
He claims he has TWO things going:
1) Dr Gho's HST
2) Stem cell therapy
If I'm going to do get HST, I'd rather get it done in Amsterdam than Mumbai!
Regarding his Stem cell therapy, a lot of companies are/did conduct trials on it and failed to produce any hairs so I don't know how he does it! This is where the concept of published peer-reviewed journals comes from. Until he does that, no one should fly over there to get it done! Period.
You know, you hear time and time again how much the outcome of a hair transplant is dependent on the skills of the surgeon. So you should really be extremely cautious when it come to these clinics in third world countries!Comment
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Yep, pretty much
OK, so first thing that needs to happen is Phase 3 needs to end! Then it takes approx. 2 months to gather all data and analyse everything.
Next step is submitting a New Drug Application (NDA) to the FDA. This involves filling out a lot of submission forms followed by (literally) a truck load of data in sealed boxes.
Once you submit your NDA, the FDA on average takes around 10-15 months to process your application.
The 6 month thing that you mentioned is granted to life-saving medications only (i.e. cancer) through a Priority Approval System! Unfortunately Aderans wont qualify for that
FDA has actually published a graph of how long it took them to process application between 1988-2008. Check it out:
(Its the second graph on the page with the heading: Median Approval Times)
So in short, from the time you complete your Phase 3, it will take another 12 months to get your product on the market!Comment
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