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CUV, CLINUVEL PHARMACEUTICALS LIMITED
seeva222
post Posted: Today, 09:45 AM
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Sun tan threatens the coral reef

https://www.instagram.com/tv/B8367tYB0ii/?i...id=zsar04mdx61o

 
Macquarie
post Posted: Yesterday, 04:39 PM
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In Reply To: macgyver's post @ Yesterday, 09:32 AM

=investing in new trials and new indications for afamelanotide and cuv's other molecules.



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Check out my wikifolio (social Trading platform):
https://www.wikifolio.com/de/de/w/wfaloevera

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macgyver
post Posted: Yesterday, 09:32 AM
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In Reply To: odi01's post @ Yesterday, 06:39 AM

Thanks for the post, I do have an issue with this line though...(a throwaway line by the author no doubt)

QUOTE
The company continues to reinvest its (now very high) profits in new drugs and the research into further fields of application for its current active ingredients.


Say what??

 
seeva222
post Posted: Yesterday, 07:06 AM
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In Reply To: odi01's post @ Yesterday, 06:39 AM

Thanks for the translation! Very helpful

 
odi01
post Posted: Yesterday, 06:39 AM
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for a better world
Clinuvel is a biopharmaceutical company developing drugs for the treatment of a number of serious skin diseases. My Australian colleagues, among others, drew my attention to this company.
Its lead drug, SCENESSE, is used to treat erythropoietic protoporphyria (EPP). EPP is a rare, lifelong genetic disease characterized by severe skin intolerance to light, leading to unbearable pain, swelling and scarring. People living with EPP must avoid sunlight and often stay indoors. According to the company, approximately 10,000 people worldwide are affected by EPP.
SCENESSE is also used in the treatment of vitiligo, a common skin disease in which the skin's pigment-producing cells are missing. The company estimates that Vitiligo affects between 0.1 and 2% of the world's population (7.6 to 152 million people).
Clinuvel currently has a virtual monopoly. SCENESSE is the only drug approved for the treatment of EPP. The drug is currently approved in the EU and since October last year also in the USA.
The company continues to reinvest its (now very high) profits in new drugs and the research into further fields of application for its current active ingredients. Clinuvel could thus be able to help even more people with other diseases, some of which are serious and currently difficult to cure

https://m.onvista.de/news/3-wenig-bekannte-...-welt-330570623


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bretto32
post Posted: Feb 21 2020, 04:50 AM
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In Reply To: mrdax's post @ Feb 21 2020, 01:37 AM

I believe they did the same last year, it is in the days leading up to rare disease day.


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macgyver
post Posted: Feb 21 2020, 03:57 AM
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In Reply To: Dr Wally's post @ Feb 20 2020, 07:06 PM

Obviously. First it was the FDA doing everything to stop it. Now they are doing everything to get the drug to patients. It’s a love/hate affair with them.... wub.gif grrr.gif

 
mrdax
post Posted: Feb 21 2020, 01:37 AM
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Lately, CUV is posting about some rare skin diseases...
Have those been seen before on the CUV and/or FB page?

Actinic Prurigo (AP)
https://www.clinuvel.com/photomedicine/scie...actinic-prurigo

Urticaria Pigmentosa (UP)
https://www.clinuvel.com/photomedicine/scie...a-pigmentosa-up

And lastly, Hydroa vacciniforme (HV), this post on FB:
QUOTE
"Hydroa vacciniforme (HV) is a rare, chronic photosensitivity disorder commonly occurring in children. The disease is characterised by the eruption of inflamed bumps and fluid-filled blisters (vesicles) on the skin following exposure to sunlight. Commonly presenting on the face, ears and hands, these vesicles heal over time as pox-like or “vacciniform” scars. Ultraviolet A (UVA) radiation (320-400nm) is the main wavelength of light which has been demonstrated to induce symptoms."

https://www.facebook.com/clinuvel/photos/a....57553541136311/
Which, unprofessional as they are, links to https://zcu.io/7OzC which basically is a dead link (at least for me).


Are those listings just for the sake of completeness to build awareness of rare skin diseases...?
Or is any of those a future target for the "photoprotective company"


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PortugueseMan
post Posted: Feb 20 2020, 10:49 PM
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FRANCE

The HAS is officially evaluating Scenesse : https://www.has-sante.fr/jcms/p_3114053/fr/...des-medicaments
French EPP patients can give their opinions until April 2.

HAS Twitter


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Dr Wally
post Posted: Feb 20 2020, 07:06 PM
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In Reply To: endymion96's post @ Feb 20 2020, 04:13 PM

“”At the start of the year and with the “EPP season” nearing in the Northern hemisphere, our teams find themselves in the midst of preparing for all mandatory European activities, while the US discussions with payors and intermediaries are progressing to facilitate access to SCENESSE® (afamelanotide 16mg).1

Simultaneously, the FDA is reviewing the obligatory post-marketing protocol to ensure CLINUVEL will remain in compliance with its requirement to monitor American EPP patients for the duration of a minimum of eight years (up to 2027).

As stated during the investor call on 9 October 2019, US distribution will be staged and depending on logistics, training & accreditation,*** final post-marketing
authorization protocol signed off by the FDA before we will see patients on treatment.”” ***


My basic understanding is that “payors” are obligated to cover drugs that have been FDA approved so “payors” shouldn’t be the cause of further brain numbing delays??

As for the FDAs “final post-marketing authorization protocol” designed specifically for Scenesse roll out?? because of the potential for photo protective tanning abuse, God only knows how draconian and convoluted and time consuming that could end up being.

I’m sure though the FDA (seeings in 2019 they approved Scenesse) wouldn’t want to be the only reason why US EPP community are stillunable to access safe Scenesse photo protection still in the coming months so I’m sure their extremely keen to be signing off on the pm protocol.

Obviously the FDA would be working around the clock to avoid killing another summer of Scenesse protection for US EPP community and Clinuvel sales.



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“” The discovery of the endogenous melanocortin agonists in the 1950s have resulted in sixty years of melanocortin ligand research.””

The never ending quest to have Afamelanotide (peptide) (SEMI) accepted for its potent ability to stimulate a natural photoprotective,cancer preventative, therapeutic “tan” was (SEMI) accomplished in 2019.

Regulator ignorance, bias, and stubborn resistance to Scenesse are the primary reasons behind this glacial journey. The evidence should be clear to all by now.

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