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post Posted: Today, 01:20 AM
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In Reply To: KRD's post @ Yesterday, 11:50 PM

I think the standard is to issue the response at COB, after markets close, the Friday before the date.

post Posted: Today, 12:00 AM
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Gee the shorter has been working hard to keep a lid on the share price.

In order to stop the price running away on them on Thursday morning (19th Sept) it appears they sold ~175k shares in the first hour. To me this is a very bullish sign.

Sure the shorter has been able to drive down the share price (with additional artificial selling) however at some stage they will have to repurchase nearly 3 million shares.
I can see 3 possible scenarios:
1) If CUV receives a CRL the shorter could potentially close their positions at a decent profit
2) Related party transactions allow the shorter to close their positions at a slight profit/break even (pretty sure this is illegal as it would imply share price manipulation wouldn’t it?)
3) CUV share price driven to all new highs via a short squeeze

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Said 'Thanks' for this post: CUV88  odi01  Justinian  BS45  
post Posted: Yesterday, 11:50 PM
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The federal government's fiscal year closes on September 30th. Many federal agencies have employee performance plans that have ties to completing active projects prior to that date. The FDA extension to October 6th has never made a lot of sense since that falls on a Sunday. Would not be at all surprised if the FDA decision comes out next week.

post Posted: Yesterday, 08:14 PM
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In Reply To: bretto32's post @ Yesterday, 06:07 PM

Come back September 2028.

Said 'Thanks' for this post: garthyd  
post Posted: Yesterday, 06:07 PM
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Just double checking, is today the first day we might head of approval? 20th September...

post Posted: Yesterday, 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


post Posted: Yesterday, 12:02 PM
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In Reply To: Justinian's post @ Yesterday, 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

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  
post Posted: Yesterday, 11:29 AM
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In Reply To: PunkassDerm's post @ Yesterday, 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.

post Posted: Yesterday, 10:54 AM
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In Reply To: PunkassDerm's post @ Yesterday, 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  
post Posted: Yesterday, 09:43 AM
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New article, still have it F-ING wrong!

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


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):

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  Clinhope  

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