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CUV, CLINUVEL PHARMACEUTICALS LIMITED
xray
post Posted: Today, 08:14 PM
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In Reply To: bretto32's post @ Today, 06:07 PM

Come back September 2028.

 
bretto32
post Posted: Today, 06:07 PM
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Just double checking, is today the first day we might head of approval? 20th September...

 
polyphemus
post Posted: Today, 01:21 PM
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As a reminder of current EPP patient experiences which have probably been linked to before but they are real people real experiences that should get a result on the 6th October:

Coming out of the shadows: A new treatment may help people who are allergic to the sun

Patient empowerment and access to medicines

A journey to successful protection with Scenesse


 
PunkassDerm
post Posted: Today, 12:02 PM
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In Reply To: Justinian's post @ Today, 11:29 AM

But also did not increase, even with increased sun exposure. I'd say positive.

Afamelanotide for Erythropoietic Protoporphyria
N Engl J Med. 2015 Jul 2; 373(1): 48–59.


Liver disease ranging from pigmented gallstones to cholestasis, cirrhosis, and liver failure develops in a small percentage of patients with erythropoietic protoporphyria. These complications are unlikely to be influenced by afamelanotide, since the liver disease is related to high protoporphyrin levels that do not change with afamelanotide treatment (Table S2 in the Supplementary Appendix).


Below found in supplemental material

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4780255/#SD1

B. Effect of afamelanotide and placebo on erythrocyte free protoporphyrin IX levels
In the EU trial protocol, erythrocyte free protoporphyrin IX levels were measured at each visit, to
determine whether afamelanotide might cause changes in protoporphyrin IX concentrations. As this
was not the case, and as similar lack of change had been observed in the phase II study performed in
the US, measurements of free protoporphyrin IX levels were not included in the protocol of the present
US study.


Said 'Thanks' for this post: Justinian  polyphemus  
 
Justinian
post Posted: Today, 11:29 AM
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In Reply To: PunkassDerm's post @ Today, 09:43 AM

Didn’t someone post a study a little bit ago about how Scenesse lowered protoporphyrin? I can’t find it through Google.

 
hibchibbler
post Posted: Today, 10:54 AM
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In Reply To: PunkassDerm's post @ Today, 09:43 AM

Ahh, I see what you did there.
People are cherry-picking source information. Creating a false impression.


Said 'Thanks' for this post: PunkassDerm  Billy Boots  
 


PunkassDerm
post Posted: Today, 09:43 AM
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New article, still have it F-ING wrong!
WRONG WRONG WRONG

No anti-oxidant properties, no anti-inflammatory properties. Just the tan, more ignorant idiots,

ATTENTION PW, PLEASE CORRECT THESE AUTHORS. HOW ABOUT EARN THOSE PERFORMANCE RIGHTS THAT YOU DELAYED APPROVAL TO DRAFT?


https://advances.sciencemag.org/content/5/9/eaaw6127.full


The essential role of the transporter ABCG2 in the pathophysiology of erythropoietic protoporphyria
Pengcheng Wang1,*, Madhav Sachar1,*, Jie Lu1, Amina I. Shehu1, Junjie Zhu1, Jing Chen1, Ke Liu1, Karl E. Anderson2, Wen Xie1, Frank J. Gonzalez3, Curtis D. Klaassen4 and Xiaochao Ma1,†
Science Advances 18 Sep 2019:
Vol. 5, no. 9, eaaw6127
DOI: 10.1126/sciadv.aaw6127

Current therapies for phototoxicity in patients with EPP focus on decreasing the permeation of light into the skin and/or managing skin lesions resulting from light-excited PPIX (5, 14, 15). Beta-carotene has been used in patients with EPP because of its antioxidant effects, as well as its ability to increase skin pigmentation and reduce the penetration of light into the skin, but is marginally effective (5, 16). Afamelanotide reduces the skin symptoms in patients with EPP by increasing melanin synthesis and decreasing the penetration of light into the skin (17). Despite these treatment options, no therapy currently addresses the underlying cause of phototoxicity in EPP, which is the accumulation of PPIX in the skin.


...Then from citation 17 (conveniently omitted):


https://www.nejm.org/doi/full/10.1056/NEJMoa1411481


Afamelanotide for Erythropoietic Protoporphyria
Janneke G. Langendonk, M.D., Ph.D., Manisha Balwani, M.D., Karl E. Anderson, M.D., Herbert L. Bonkovsky, M.D., Alexander V. Anstey, M.D., D. Montgomery Bissell, M.D., Joseph Bloomer, M.D., Chris Edwards, Ph.D., Norbert J. Neumann, M.D., Charles Parker, M.D., John D. Phillips, Ph.D., Henry W. Lim, M.D., et al.

July 2, 2015
N Engl J Med 2015; 373:48-59
DOI: 10.1056/NEJMoa1411481

Afamelanotide (Scenesse, Clinuvel Pharmaceuticals) is a potent analogue of human α-melanocyte–stimulating hormone (α-MSH).19-21 It is a tridecapeptide that binds to the melanocortin 1 receptor (MC1R) in dermal cells, including melanocytes, and increases the production of eumelanin in the epidermis without the ultraviolet light–induced cellular damage that occurs when melanin production is stimulated by ultraviolet radiation.21,22 Melanin, in the form of eumelanin, is photoprotective.23 It absorbs, scatters, and quenches ultraviolet light, scavenges free radicals, and acts as a neutral density filter that reduces all wavelengths of light equally.23,24 Moreover, melanogenesis may provide a major antioxidant defense in melanocytes, neutralizing the deleterious effects of free radicals and reactive oxygen species.24,25


Said 'Thanks' for this post: xray  
 
Johnny H
post Posted: Today, 08:32 AM
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It appears that the recently released prescription drug price control legislation introduced by House Democrats, in its current form, will not affect the pricing of Scenesse:
https://www.healthaffairs.org/do/10.1377/hb...19.459441/full/



QUOTE
The core of the House’s package is the authority it provides to the HHS Secretary to negotiate directly the prices of prescription drugs (Section 101). This authority is not unlimited. The Secretary is only empowered to negotiate prices on the 250 branded drugs “with the greatest cost to Medicare and the whole U.S. health system” that lack “a generic or biosimilar competitor.”




--------------------
Clinuvel until my bowels release for the last time.

Said 'Thanks' for this post: oystercatcher  
 
IntiRaymi
post Posted: Yesterday, 10:32 PM
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In Reply To: macgyver's post @ Yesterday, 05:47 PM

Can you explain how that works, macgyver? My basic understanding of the markets only allows me to imagine that when a large amount of shortsellers have to simultaneously buy back the shares they borrowed and sold and now owe, surely this must create a supply issue therefore increase in price?

 
macgyver
post Posted: Yesterday, 05:47 PM
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In Reply To: LevelHeaded2000's post @ Yesterday, 05:29 PM

You can thank the shorts for the volume and no one else. Don’t be surprised to see significant volume with little movement in the sp. it would be nice to see other punters jumping in and buying up to put the squeeze on but I think these guys are all over it.

 
 


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