"Do you have any idea how many more years it will be before regular Joe and Janes can get Clinuvel's drug at an affordable price?"

Neither have you, but it dosen't stop you from making statements like that, same about pricing, nobody knows, unless you're a board member of the company.....clinuvel will place the drug on the market for EPP first, where it moves from there one....future will tell....not you and me!
 
Best regards,
 
Poissonke

There has been a lot spoken about the cost of the implant once it receives market approval and l appreciate we can only speculate BUT what are your thoughts on the cost????
$200, $2000, $20000 an implant????  
 
Plus, do you not think the FDA would intervene if Clinuvel pursue the EPP indication route only as there are millions who would benefit from this drug.
 
It would be unethical  to restrict this from the indications it was originally intended for.
Over one million new cases of skin cancer are diagnosed in the US yearly!!!

Hey guys –  
 
Responding to some of your latest comments…
 
Cruserx – You’ve got it nailed down.  EPP will not be enough.  That’s one of the reasons the share price is so low.  Clinuvel’s PLE trial was not statistically significant.  They have to do it over again now.   As others mentioned, we all knew the drug was safe.  So, that was not going to move the share price up much just reporting the drug was found to be safe in the PLE trial.    
 
PLE is our hope for broad indication.  Without it, we just have EPP and maybe SU.  That’s not cool with shareholders.  So that was actually bad news.  No one wants to see them have to do a trial over again and hope they get it right this time.
 
Even the EPP trial was statistically significant for only 35 of the 100 patients.  That may or may not be enough for the regulators.   But Clinuvel has to do supplemental a EPP trial.    More delays!
 
ARJ – I could not agree with the last paragraph in your latest post more.  Right on!  The FDA is run by *#(@#% who don’t have a clue.
 
Newnameolduser – I’m not sure how the new healthcare bill would impact Clinuvel.  The whole healthcare debate turns me off and I tune it out.  
 
Clinuvel’s CEO Dr. Strangelove has already said he will price the drug high.   A close source told me the price will shock people with how high it will be.  
 
I was reading on a stock forum where someone said Clinuvel no longer says on their website they are opening a office in New Jersey – so I checked their website and sure enough, they no longer say New Jersey.   I wonder what that is all about.  Maybe they won’t be doing a US trial soon after all.    
 
For the woman who has EPP who posted here last month they were about to get started with a trial and she was going to be in it, unless she or someone else says the trial is still on and they are told when it will start, then I have to wonder if these guys have scrapped the US trial for 2010.    
 
The wait on this drug just goes on forever.  I wish we had another company that was working on a product such as this.   Wonder whatever happened to Bryan Fuller's MelanX?    
 
Happy New Year Gents (and Ladies)

If dodgy sunscreens looked healthy and attractive when they were applied to our skin would people freak out and carry on as though it was the end of the world like they do with the Melanotan Peptides?  
They are so much better in so many ways than any man made sunscreen and will mmost likely be proven to be much safer as well.
Is it even possible to have the cosmetic (tan) and not have the UVR protection? If not, why is there even an issue concerning Afamelanotides cosmetic side effect.

Hey, all!  It's "the woman who has EPP" and is hoping to participate in the clinical trial.  I am a member of the APF, American Porphyria Foundation and they are posting updates from Clinuvel.  I'm in a hurry and too lazy to quote it, lol, but they just posted an update Jan 25th that they are proceding with the US trials.  I have requested more info, but likely will not hear from them until they are ready to start.  I sure hope I don't get the placebo...that would just plain "suck".  I have been having increased sensitivity this last year and I don't know how I will survive another summer.  Last summer, on a quite cloudy day on the coast, i was outside less than an hour and avoiding the sun the best I could.  I burned so bad, the swelling prevented me from making a fist and the pain and burning kept me awake 3 nights with constant doses of diphenhydramine (benadryl) and ibuprofen.  And when I say awake, I mean with not a wink of sleep!  It was not pretty and we were on a family vacation.

Thanks!  I'm trying so hard to be patient until I get more info!

I definitely don't want to jeopardize my chances for participation!  I will be patient and do a lot of praying that if I do get to be included(pretty sure I will) that I don't get the placebo!  . In the previous trials, the participants with EPP were allowed to continue the medication after the trial period ended.  The BIG question is did the poor souls who received the placebo get that option??  Sure hope so!!

Oh, thanks, Scott!  I do seem to remember something about staggered doses, just wasn't sure that meant everyone tried it.  That's a relief!  

Well, here's the notice on the APF website.
Notice of IND Status:
 
www.clinuvel.com/resources/pdf/asx_announcements/2009/20090129IND.pdf
 
this is a link to the Phase III Eurpoean trials for those interested:
 
http://clinicaltrial.gov/ct2/show/NCT00979745
 
 

Any updates?