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market ready (Read 25036 times)
Rachy Rach
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Re: market ready
Reply #40 - 09/27/09 at 16:11:32
 
Companies are in business for one reason so limiting the amount of implants would be a really strange thing to do.
 
Golfsullivan, melanotan has been around for decades. If there were any nasty side effects lurking they would have been found by now you would think. It works so well that it would be unethical not to release it in my opinion.   
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« Last Edit: 09/27/09 at 16:49:03 by Rachy Rach »  
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Nanelle
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Re: market ready
Reply #41 - 12/27/09 at 04:15:21
 
I am supposed to be a participant in the clinical trials set to start in the US this year.  I have EPP and I find it bothersome that so many people posting here seem to think they "need" this medication and will use whatever means necessary to get it.  How many here are actually sufferers of the diseases it is targeted to treat?  It may be helpful for people with fair skin, but so is sunscreen and avoiding the sun.  The drug is meant to improve the quality of life for people like me, not become the next designer drug.  That being said, be patient while they try it out on all the poor people who need it to survive in the sun, then when they deem it safe after another 10 years, it will be deemed safe for the general public if in fact it is.
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Re: market ready
Reply #42 - 12/27/09 at 05:34:17
 
Quote from Nanelle on 12/27/09 at 04:15:21:
I am supposed to be a participant in the clinical trials set to start in the US this year.  I have EPP and I find it bothersome that so many people posting here seem to think they "need" this medication and will use whatever means necessary to get it.  How many here are actually sufferers of the diseases it is targeted to treat?  It may be helpful for people with fair skin, but so is sunscreen and avoiding the sun.  The drug is meant to improve the quality of life for people like me, not become the next designer drug.  That being said, be patient while they try it out on all the poor people who need it to survive in the sun, then when they deem it safe after another 10 years, it will be deemed safe for the general public if in fact it is.

Nanelle,
Welcome to the forums and thanks for sharing here. While I am inclined to agree with your sentiments relative to folks' "need" of melanotan-1 please do understand that the development of afamelanotide [melanotan-1] as a potential treatment option for sufferers of EPP is a relatively new thing. When Clinuvel (originally called EpiTan) was first working to bring it to market it was primarily as a defensive treatment for preventing sunburns. In fact almost since their inception the melanotan peptides have been touted as a potential treatment to develop a protective (and let's face it, attractive) tan. So folks who have been following the development of these drugs for some time are understandably feeling frustrated and yes perhaps feel as though they do "need" a drug that would allow them to develop a protective layer of pigmentation. This "need" is frequently expressed by individuals who cannot develop any pigmentation at all (Fitzpatrick type I) or very little (Fitzpatrick type II) without the usage of a drug like one of these peptides that stimulates their underperforming melanocytes.
 
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« Last Edit: 01/27/10 at 06:32:54 by Scott Stevenson »  

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Re: market ready
Reply #43 - 12/27/09 at 10:04:39
 
Quote from Nanelle on 12/27/09 at 04:15:21:
I am supposed to be a participant in the clinical trials set to start in the US this year.  I have EPP and I find it bothersome that so many people posting here seem to think they "need" this medication and will use whatever means necessary to get it.  How many here are actually sufferers of the diseases it is targeted to treat?  It may be helpful for people with fair skin, but so is sunscreen and avoiding the sun.  The drug is meant to improve the quality of life for people like me, not become the next designer drug.  That being said, be patient while they try it out on all the poor people who need it to survive in the sun, then when they deem it safe after another 10 years, it will be deemed safe for the general public if in fact it is.

 
 
Nanelle,
 
With respect I think you are unfairly 'protectionist' here. Many people who have suffered years of sunburn, pale skin, being the butt of jokes and at risk/fear of having skin cancer should have access to this drug and not just the people with a specific disease. As far as I am aware, the original inventors of the drug never intended to make it a medication for' this or that' disorder anyway. It was meant to be a generic discovery to help all those people who cannot tan naturally develop photoprotection. So in my opinion it is unfair to present with a 'holy than thou' mind set because you have a specific disorder that fits the current clinical trials. Having type 1 skin is a curse for many in itself and using incessant, greasy, sunblock and staying out of the sun all the time is very hard to maintain as well as causing deep feelings of inadequacy and exclusion.
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Re: market ready
Reply #44 - 12/28/09 at 18:35:02
 
With all respect Darkhorse did you ever loocked wat EPP is all about, i think pale skin, being the butt of jokes etc. dosen't compare well to not being able of having a normal and social live like normal people are able to do...look at this h//p://vimeo.com/8303627 before you make a reply or statement that hits people with this serious condition in to the face...i personaly feel happy about the fact this product will have a serious reason to excist, it can help these people first, and finaly will be the only reason this product wil become available for everybody in the future!
This product available for only cosmetic use was just a wett dream from (epitan) in the past, the future will be for clinical use, i hope it wil help people, that it will be reachable for everybody and will make me bloody rich by doing so....
 
best regards,
poissonke
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Nanelle
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Re: market ready
Reply #45 - 12/29/09 at 02:22:33
 
Thank you, poissonke.  Darkhorse, i am not sure where you have the right to say I have a holier than thou attitude.  If by me having a rare debilitating genetic disorder that severly limits my quality of life makes me holier than thou, then it is by your definition.  I simply see it as a priority to receive a medication.  My statement was just to say that it should only be given to the people who will benefit the most despite the possible risks involved first.  Erythropoietic Protoporphyria ia something I wouldn't wish on my worst enemy.  Please read up on it and the other condtions this medication will be most beneficial for.  The medication, as I said will probably become available after it is given substantial testing time (in years) on the people whose need outweighs their risk.  If you are indeed as fair skinned as I am, then you no doubt are at an increasd risk for skin cancer.  I, however am in more imminent danger from the sun.  The good thing is, because there is no treatment yet available for my condition, there are good people that are funding the research for the treatment that will help people like me, and eventually people that are afraid they may get skin cancer someday, or just want a tan will benefit as well.  I will be sure to return and report what my experiences are when I am contacted for the clinical trials!
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Re: market ready
Reply #46 - 12/29/09 at 12:42:15
 
Quote:
there are good people that are funding the research for the treatment that will help people like me..

 
Definitely not, Nanelle!
It is naive to think that these people are good and want to help you. There are a lot of other diseases which are more serious and deadlier than EPP. There are diseases which have a higher prevalence than EPP but they are not funded. Why do u think there are no fundings for these diseases??The answer is that the potential of these drugs is limited. But not for afamelanotide [melanotan-1]. This drug will soon become a blockbuster , not for EPP, SU and PLE but for the cosmetic market.  If u go back to the market introduction of viagra. It was only for men who suffers from impotence. Now, the drugs is commonly used in the porn industry and it can be bought in the UK without prescription. Clinuvel only promotes its drug for these diseases to ensure its pole position for later, for the cosmetic industrie.
 
The only thing Clinuvel is focusing on is: PROFIT.  
Because all their clinical studies were very costly, clinuvel has to make benefits. And they cannot do it by only giving afamelanotide [melanotan-1] for people with EPP.
 
 
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Nanelle
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Re: market ready
Reply #47 - 12/29/09 at 21:05:34
 
Yes, Clinuvel is primarily for profit, and I believe you are saying the same thing as me when you say they are funding for specific diseases to secure their "pole position" for later, cosmetic use. I dont dispute either of these claims. And I assure you, And I assure you, I am not naive.  Please be careful how you address people here as it can be easily taken as rude.  If by these other diseases, you mean skin cancer, i assure you there has been plenty of funding towards skin cancer research.  Can you give me examples of which diseases are more prevalent and deadly but are not funded?  If you mean funding for this product specifically, you may be right.  However, there has been very little funding and virtually no advancement regarding treatment options for those of us with EPP until now.  Either way, I can assure you that while the majority of the funding is probably driven by desire for profit, there are organizations that are contributing to the research specifically to help people like me with rare conditions that currently have no treatment options.  One of which is the American Porphyria Foundation, which I am a contributing member of, and is why I am able to participate in the upcoming clinical trials.  I can assure you that they are there to help me personally and I will continue to support them.  The leading expert in The US for EPP called me the day I called her to offer help and support and the foundation is supporting research for all Porphyrias.  I will return here to offer information and education to those of you who are interested regarding the upcoming trials.  And really with all due respect, as I can see that some of you are intelligent reasonable people, I do not care to continue debating the merits of afamelanotide [melanotan-1] for this or that condition or who should eventually get it.  I simply would like to see it help anyone who is truly unable to live a normal life first.  As I said before, once they proper trials are run, and it is approved for general use by the FDA, then it will probably be available to any fair skinned person who is in the high risk category for skin cancer, which is virtually half the worlds population.  I live in California and even though we are in a high risk area with lots of light skinned people, I have yet to run in to one person who is even close to my level of sun sensitivity. I burn about 8 to 9 months of the year.  My sunburn is NOT a normal one.  It is intolerable and I am usually awake 3 nights in a row.  Then even the slighest touch hurts and any additional sun, even through windows keeps me in a burned condition longer.   Im fairly safe from November thru February.   For those of you that are that sensitive, I'm sorry and my advice is the same to you as it has been given to me.  Wear sunscreen, hats, etc.  Avoid the sun and if I can survive that way, Im sure you can too.  Thanks for reading my ridiculously long post!
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Re: market ready
Reply #48 - 12/29/09 at 21:07:04
 
LOL...I did not mean to say "I assure you" twice.  Grin
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Re: market ready
Reply #49 - 12/30/09 at 16:27:58
 
Quote from Nanelle on 12/29/09 at 02:22:33:
Thank you, poissonke.  Darkhorse, i am not sure where you have the right to say I have a holier than thou attitude.  If by me having a rare debilitating genetic disorder that severly limits my quality of life makes me holier than thou, then it is by your definition.  I simply see it as a priority to receive a medication.  My statement was just to say that it should only be given to the people who will benefit the most despite the possible risks involved first.  Erythropoietic Protoporphyria ia something I wouldn't wish on my worst enemy.  Please read up on it and the other condtions this medication will be most beneficial for.  The medication, as I said will probably become available after it is given substantial testing time (in years) on the people whose need outweighs their risk.  If you are indeed as fair skinned as I am, then you no doubt are at an increasd risk for skin cancer.  I, however am in more imminent danger from the sun.  The good thing is, because there is no treatment yet available for my condition, there are good people that are funding the research for the treatment that will help people like me, and eventually people that are afraid they may get skin cancer someday, or just want a tan will benefit as well.  I will be sure to return and report what my experiences are when I am contacted for the clinical trials!

 
 
Nanelle,
 
Firstly, I genuinely apologise if my post offended you or other sufferers of your condition. In retrospect I can see your disgruntlement at my use of the expression 'holy than thou'. However, this statement was directed at your apparent attitude towards non-EPP melanotan users and certainly not meant as an insult at you because you have the condition. Also, I stand by my opinion that your post is 'protectionist' and (perhaps unintentionally?) critical towards people who have suffered a lifetime of pale skin and related physical/psychological problems. Just because some individuals have a specific, particularly debilitating skin condition doesn't mean that other people shouldn't be able to benefit from medication for less severe problems. The bottom line for me is that these peptides can potentially benefit ALL OF US, so why suggest divisions?  
 
Now..if there was only limited melanotan around in the world, or a need to choose between access for the GENERAL population v Disease sufferers, then of course people with specific diseases should be prioritised. But given that neither of these conditions are upon us, I cannot understand your comments at all. Melanotan usage in the general population will not effect the development of the drug for specific clinical groups and it's an individual's choice to use the drug and weigh up the potential risks. Therefore I can see no need to express a sense of 'us v them', 'I need it more than you' and so on... I could only see your argument applying to a small degree to type III or type IV users who taking the drug for largely cosmetic reasons. But for us pale-faced, sun-burned, skin-cancer anxious type I and II's, melanotan has been a really gift...so why should we not have the right to choose to use it or not just because there are other people in the world who diseases that are more dramatically treated with melanotan.
 
Also...you have wrongly and unfairly concluded that I have no awareness of the condition EPP...and I see that you did not respond to my statement that melanotan was not originally intended or developed for your specific disorder..but for a generic treatment to individuals with an inability to produce melanin..I believe Scott also made this point....
 
In any case..please understand that I do not mean any personal offence to you or to sufferers of EPP, but see my comments in relation to your 'argument' only.  
 
Best wishes  
 
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« Last Edit: 12/30/09 at 16:59:46 by darkhorse »  
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Nanelle
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Re: market ready
Reply #50 - 12/30/09 at 19:46:39
 
I meant no offense in my post either.  I am a fair skinned type I also.  I just have additional criteria for benefitting from the drug.  I think it should be available to whoever will have health benefits from it once it has been approved by the FDA.  I know it is frustrating to wait for something, but there has to be clinical trials done on small specific groups before they are done on the general public, and it all takes time.  We are just about to start trials here in the US, so it will be a long time before the general public will be able to get it.  For me to participate in the trials, I will have to accept whatever risks there are, and am quite sure I will have to release all liability of the company.
I am  not suggesting divisions, the drug companies have to be very careful about product safety and risk.  Those same people out there that are posting, "I want it now!" AND "Why can't I have it?"  are the ones who, in ten years if they have some problem unforeseen, will be bringing up a class action lawsuit against the drug companies.  They will conveniently forget that they didn't care what the long term effects could be when they begged for the product years before.  
 
When a drug is developed, it is beneficial to the developer to market it as a broad, far-reaching product, ie. for everyone who is fair-skinned.  But to get it to that audience, must prove its effectiveness and safety.  This is much more easily done within a sub-group with higher sensitivity to light.  The results will be more dramatic and measurable and accepted as most beneficial to the recipient. This will help to get approval for less severe reasons.  As I see it, if it weren't for the rare conditions it can treat, the medication might not ever reach the general public!  I think the two depend on each other.  One (rare diseases) to get it moving in the right direction and two (general public sun protection)to keep it there, since the money will be made from the larger audience.  So, thank you all you non-rare disease fair skinned people.  And you can thank me later for helping to get it to you.  Wink And if it doesn't make it there for safety reasons, I will be sure to let you know if I experienced any of it, and whether it was worth the risk after all. undecided  If I trade places with any one of you, I'd be glad to give up my spot to just have the fair skin and cancer risk, and wait.
 
Sirler, can you please clarify which diseases this will treat that are not funded, and more deadly than EPP?  Huh You didn't answer that and I don't think you're speaking of skin cancer because there is definitely funding there.  As far as there being no limit to melanotan, if you want the proven safe version from the drug companies, then YES it is limited, for the very reasons I stated.  I believe many of you know where to get the injected "of-market?" kind.  That is where you can make your own choice.  If you want the product backed by the FDA, in implant form, you'll have to wait like everyone.  Or are you saying you can't get melanotan?  It sure seems like a lot of people here have found it.  And if it is so safe, then why is everyone talking so much about waiting for it?  Can any of you clarify as to he availability of it? This I don't know much about.  Thanks!
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Re: market ready
Reply #51 - 12/31/09 at 01:12:38
 
I agree with what Scott and Darkhorse said 100%.  
 
Poissonke, no one is saying EPP is not a serious disease.    
 
Nanelle- I hope you will continue to post here and you are invaluable to this forum since you have EPP, but I also found your original post offensive.  And note that this was my visceral reaction before I even read the others’ follow up posts to your post.
 
First off, for those of us at high risk for skin cancer (my family has skin cancer and some friends have had it) we also need a photoprotective drug like this – just as Scott said.
 
The idea that just slopping on sunscreen will do the trick and this drug is just for EPP patients is ridiculous and ignorant.   Guess what - a family member put on sunscreen daily and she got skin cancer.  
 
Do you know that in studies sunscreen has been found to be largely ineffective?  
 
And you say - "just be patient and wait 10 more years" -  
 
Excuse me?   My family has waited 20+ years for this drug.   Just another 10 years to wait, right?  What's another 10 years after all…. there are some people on this forum who will be senior citizens in 10 years.    
 
Do you know how many people die of skin cancer each year?  Over 10,000 in the USA.  That's much more than EPP patient populations here.  
 
But we have to save EPP patients long before (10 years) we allow the drug to be available for those of us who also have extreme trouble with solar damage.   The majority are screwed I guess?  
 
 
So, this “get in the back of the line stuff” is for Ken and Barbie dolls looking to look good for the prom.   Not for those of us who cannot go out in the sun without coming home with some good old precancerous goodies.
 
The regulators need to get their heads out of their rear ends if this is not going be available to fair skinned people for another 10 years.
 
Sure, we'll save the world for the 5,000 that have EPP.  The rest of us can get skin cancer and buy a coffin.  That makes as much sense as a rubber crutch.
 
But then again, we don't really need it and can wait another decade for melanoma, right?  
 
Maybe the Chinese will make their own implant for those of us who are sick and tired of waiting on this stupid drug.
 
Hopefully you will be able to afford Clinuvel’s drug (I wish they didn’t have possession of it) and it benefits you.  
 
Have they bothered to tell you how much you'll have to pay for it?  Will your insurance company pay for it?   I hope so.  Otherwise, it's the implant or a used car.
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« Last Edit: 12/31/09 at 01:49:04 by StarryNight »  
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Re: market ready
Reply #52 - 12/31/09 at 01:36:05
 
Darkhorse --
 
I just read your latest reponse here and all I can say is kudos for expressing it so well.   I just wanted to pound my fist in the air and say, "YESSSS!!!! SOMEBODY GETS IT!"    
 
This drug is now just for rare disease patients (for the next umpteen years) but that was never the original intent.  
 
This has gone from a drug for millions of Type I folks to a drug for a few thousand.  And while it's great for EPP folks, and NO one is denying the seriousness of EPP, well....like I said you summed it up perfectly.  
 
The regulators screwed us all with this and don't get it.  The drug has been proven safe time and time again.  Those at the FDA need to buy a clue when clues are on sale.  We have to wait 50 fricken years for longitudinal studies to prove whiteys are more at risk for melanoma.  Well, all I can say is, no crap!  Third graders know that by now!
 
Now, when is Clinuvel going to stop with all the skin cancer death rate stuff when in fact they won't even have this drug available to the majority who could benefit?  
 
How about if they just call it like it is on their website.  THey have a drug for a few thousand EPP patients.    
 
And by the way, to the uneducated -- many, many Type I people cannot live "normal" lives if by normal it is meant spend lengthy time in the sun like "normal" people do.  You don't have to have a rare disease to have live with such limitations.  
 
OK, I feel better now after getting that off my chest.
 
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pipe dreams???
Reply #53 - 12/31/09 at 11:03:24
 
StarryNight i think my reply isn't that difficult to read right, i try to clarify a bit more...
Epitans intention to bring this to market as a recreative cosmetic drug is, was just a pipe dream, the fda, emea and other regulation institutions would never ever granted this product to go to market!!!! When Epitan changed to be Clinuvel they realised they had to look for other means, different ways to get to market, now we have a first in class medical product, this gives them some benefits, better market protections, less lenghty and costly clinical trails, faster road to market (by the fda)....are they screwing you, yeaaah big time but the only way to have a commarcial well tested product on the market is this way, it has gone from a recreative cosmetic (never taken serieus) drug to real science and a respected compagny and drug....in this way we are helping people with serieus indications (EPP, PLE/PMLE, PDT, SCC, SU etc...)!
I'm not naief you know i invested in this compagny as many other people, most people think and still c this compagny to be a potential blockbuster, we will c in the future...
Greed makes the world turn arround, people provide invest in a compagny 4 profit, they risk there money because they see a market are strongly beleave in it, they want a high reward for that later, thus providing money for research, thus helping people with diseases.....BUT everybody knows the high rewards wil be in cosmetic use and high sales....do we really care yess a little bit..AND KNOW WHE WANT TO MAKE MONEY...
The same go's for clinuvel it self, you think they buried there dream of becoming very big, no they have to get to market first, the way they are profiling themself now will give them a better chance....it is the only smartest way....look at bottox, it's being approved to market for much different things it is bin used now, so it will be for amelanotide...
 
The 3th stage trails in europe are finished, preliminary results are very promissing (allmost all trail patients want to stay on the product...) they got fast track for trails in the USA...they will ask for market approvel for Europe and Australia in 2010...they start 2 trails (conformation trails in US and europe)...ask for market approvel in USA 3QT off 2010....
 
I personally think where at the end of the tunnel....i hope the outcome will be rich and available for everyone....
 
Greatings,
 
Poissonke
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Re: market ready
Reply #54 - 01/01/10 at 17:23:53
 
I don't understand why some people here feel that melanotan will be "restricted" to those with certain conditions. Once the stuff is on the market, dermatologists will be able to prescribe it off-label to anyone who walks in the door.
 
Happy New Year everybody!
 
Drew
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« Last Edit: 01/01/10 at 17:47:30 by drew »  
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Re: market ready
Reply #55 - 01/01/10 at 20:50:44
 
Quote from drew on 01/01/10 at 17:23:53:
Once the stuff is on the market, dermatologists will be able to prescribe it off-label to anyone who walks in the door.

 
and once you got the implant at the pharmacy shop you will install it yourself deeply into your hip. well, dream on.  
 
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Re: market ready
Reply #56 - 01/01/10 at 20:56:54
 
Quote from ThePaler on 01/01/10 at 20:50:44:


and once you got the implant at the pharmacy shop you will install it yourself deeply into your hip. well, dream on.


 
What are you talking about? The implant will be performed by the dermatologist, in the derm's office.
 
Drew
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Re: market ready
Reply #57 - 01/01/10 at 21:04:22
 
sure a dermatologist would risk his approbation for you having a tan for the next 6 months.
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Re: market ready
Reply #58 - 01/01/10 at 21:52:06
 
Quote from ThePaler on 01/01/10 at 21:04:22:
sure a dermatologist would risk his approbation for you having a tan for the next 6 months.

 
"Risk his approbation"?? "Approbation" means "praise".  Before you use words it might help to look them up.
 
Despite your mangling of the English language, I think I know what you're trying to say, and that is that dermatologists will not want to prescribe/administer melanotan to patients off-label. There are many reasons why this argument doesn't hold water. First, if melanotan protects people from sunburn (and by implication, skin cancer), there is a good medical argument for prescribing it, especially for fair-skinned people. Second, dermatologists are in business to help patients, but they are still "in business"; more patients means more revenue for the practice. And finally, off-label prescribing is LEGAL and commonplace; physicians do it all the time.
 
Drew
 
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Posts: 115
Re: market ready
Reply #59 - 01/05/10 at 01:54:17
 
drew -  
 
Obviously you have no idea how much the implant will cost.  It will be in the 4 figures.  The company would not be able to survive by putting out a $300 implant to < 10,000 patients.
 
The implant was originally going to cost around $300, but Wolgen the mad scientist is screwing all those who don't have EPP.
 
So, now how many people will go to their dermatologist and pay well over $1,000 for a 60 day tan.  Maybe J-Lo, Brad Pitt, and the other jet setters.   Not many from Peoria, however.
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