Comments on: Afamelanotide (Clinuvel CUV1647) gets orphan drug status in the US http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html Where the rosacea community meets to support each other Tue, 17 Nov 2009 03:38:49 +0800 http://wordpress.org/?v=2.8.6 hourly 1 By: Barbara http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-30286 Barbara Sat, 26 Sep 2009 05:36:18 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-30286 Latest commercialization dates: Q1 2011 for Europe Much later for US. Why they are delaying in the US is beyond me but it's ridiculous and really makes me angry. They got the green light to start US trials in Juanary 2009 and here we are 8 mos later and no trials have started in the US. Pathetic! Latest commercialization dates:

Q1 2011 for Europe

Much later for US. Why they are delaying in the US is beyond me but it’s ridiculous and really makes me angry. They got the green light to start US trials in Juanary 2009 and here we are 8 mos later and no trials have started in the US.

Pathetic!

]]> By: kat http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-28402 kat Thu, 18 Jun 2009 15:42:34 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-28402 I have suffered from PMLE my whole life and can not wait for this to be accepted by FDA in the US! I have suffered from PMLE my whole life and can not wait for this to be accepted by FDA in the US!

]]> By: Dale http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-27734 Dale Mon, 04 May 2009 06:40:46 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-27734 What an exciting prospect. I have 3 children with EPP and this drug could change their lives literally. What an exciting prospect. I have 3 children with EPP and this drug could change their lives literally.

]]> By: Digital Davo http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-26323 Digital Davo Wed, 28 Jan 2009 01:17:17 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-26323 Just posted is an update on afamelanotide saying that it has shown promising preliminary Phase 3 results from 14 participants in Switzerland. See: <a href="http://rosacea-support.org/afamelanotide-positive-phase-iii-results-for-erythropoietic-protoporphyria.html" rel="nofollow">afamelanotide positive Phase III results for erythropoietic protoporphyria</a> Just posted is an update on afamelanotide saying that it has shown promising preliminary Phase 3 results from 14 participants in Switzerland.

See: afamelanotide positive Phase III results for erythropoietic protoporphyria

]]> By: ray http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-26322 ray Tue, 27 Jan 2009 22:28:15 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-26322 I found the link to this on a Porphyria support group site (bless you Mariel). I've lived all my 30 years having to accomodate the impact of erythropoietic protoporphyria. I'm not ashamed to say I welled up while reading, the potential this bears is massive. Can't wait to investigate and learn more. I found the link to this on a Porphyria support group site (bless you Mariel). I’ve lived all my 30 years having to accomodate the impact of erythropoietic protoporphyria. I’m not ashamed to say I welled up while reading, the potential this bears is massive. Can’t wait to investigate and learn more.

]]> By: Peter http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-26230 Peter Fri, 23 Jan 2009 11:43:15 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-26230 Got my vote D.D. Got my vote D.D.

]]> By: Digital Davo http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-26226 Digital Davo Fri, 23 Jan 2009 06:04:40 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-26226 I think it this will be a great treatment for sun sensitive indivduals. Lets hope for a smooth Phase III process. I think it this will be a great treatment for sun sensitive indivduals. Lets hope for a smooth Phase III process.

]]> By: Peter http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-26220 Peter Thu, 22 Jan 2009 21:41:56 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-26220 I have A.K., got my semi-annual treatment today. I mentioned CUV 1647 to my dermatologist as a treatment for me, she had no problem with doing the implant after she gets a little more educated in the drug once it gets blessed in the US I have A.K., got my semi-annual treatment today. I mentioned CUV 1647 to my dermatologist as a treatment for me, she had no problem with doing the implant after she gets a little more educated in the drug once it gets blessed in the US

]]> By: Mariel http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-26217 Mariel Thu, 22 Jan 2009 19:56:04 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-26217 This would be good for me. I have the sun sensitivity of porphyria, which means I must cover up. I have HCP, which is not AS sun sensitive as erythropoetic porph, but still is sensitive. I also have had 6l skin cancers and widespread actinic keratoses. I cover up so well that I only had one cancer removed this year and two keratoses. Mariel This would be good for me. I have the sun sensitivity of porphyria, which means I must cover up. I have HCP, which is not AS sun sensitive as erythropoetic porph, but still is sensitive. I also have had 6l skin cancers and widespread actinic keratoses. I cover up so well that I only had one cancer removed this year and two keratoses.

Mariel

]]> By: Peter http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html/comment-page-1#comment-26132 Peter Tue, 13 Jan 2009 23:14:05 +0000 http://rosacea-support.org/afamelanotide-clinuvel-cuv1647-gets-orphan-drug-status-in-the-us.html#comment-26132 Looks like 2010 @ best for the US, oh well. Looks like 2010 @ best for the US, oh well.

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