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CUV, CLINUVEL PHARMACEUTICALS LIMITED
PunkassDerm
post Posted: Oct 30 2019, 08:11 PM
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In Reply To: LevelHeaded2000's post @ Oct 30 2019, 07:12 PM

You think with the worlds highest melanoma rate, Australia may eventually allow photoprotection at the right price point? Given stellar safety profile and sunscreen link to destroying coral life.
Time for a life-saving and DNA repairing alternative.

https://www.cnn.com/2018/05/08/health/austr...intl/index.html

Biggest risk in the world

Melanoma remains a significant problem in the Antipodes, in large part due to high levels of UV exposure caused by the region's proximity to the ozone hole over the Antarctic.
Australia and New Zealand have the highest rates of skin cancer in the world, according to the largest international melanoma foundation, the Texas-based AIM at Melanoma. Both countries have more than double the incidence rates found in North America.
Annual rates of melanoma in women in Australia are 10 times higher than those of women in Europe. For men, they are 20 times higher.



https://www.smh.com.au/lifestyle/beauty/wha...124-p50tbo.html


What is your sunscreen doing to the ocean?

Every summer we dutifully slip, slop, slap, and crucially so given Australia has one of the highest rate of skin cancer in the world.

Sunscreen is a non-negotiable. However new research suggests chemicals found in some sunscreens are linked to coral bleaching.

Scientists say chemicals found in sunscreen, in particular oxybenzone and octinoxate, can be just as dangerous to coral life and its depletion as warming ocean temperatures and extreme weather conditions.



https://onlinelibrary.wiley.com/doi/full/10.1002/cncr.31719

Recent progress in the treatment of advanced melanoma has led to unprecedented improvements in overall survival and, as these new melanoma treatments have been developed and deployed in the clinic, much has been learned about the natural history of the disease. Now is the time to apply that knowledge toward the design and clinical evaluation of new chemoprevention agents. Melanoma chemoprevention has the potential to reduce dramatically both the morbidity and the high costs associated with treating patients who have metastatic disease. In this work, scientific and clinical melanoma experts from the national Melanoma Prevention Working Group, composed of National Cancer Trials Network investigators, discuss research aimed at discovering and developing (or repurposing) drugs and natural products for the prevention of melanoma and propose an updated pipeline for translating the most promising agents into the clinic. The mechanism of action, preclinical data, epidemiological evidence, and results from available clinical trials are discussed for each class of compounds. Selected keratinocyte carcinoma chemoprevention studies also are considered, and a rationale for their inclusion is presented. These data are summarized in a table that lists the type and level of evidence available for each class of agents. Also included in the discussion is an assessment of additional research necessary and the likelihood that a given compound may be a suitable candidate for a phase 3 clinical trial within the next 5 years.


Melanocortin 1 Receptor Agonists

α‐Melanocyte‐stimulating hormone (α‐MSH) is a melanocortin derived from the precursor polypeptide pro‐opiomelanocortin, which is produced in the pituitary gland and by UV‐irradiated keratinocytes in the skin. α‐MSH binds to and activates the melanocortin 1 receptors (MC1Rs) located on the plasma membrane of melanocytes.21 There are 3 forms of MSH, α‐MSH, β‐MSH, and γ‐MSH, which bind with different affinities to MC1Rs. α‐MSH is a full agonist of the human MC1R. MC1R is polymorphic in human populations and is a determinant of hair and skin color as well as the risk for melanoma. MC1R activation by α‐MSH produced in keratinocytes results in the stimulation of photoprotective eumelanin (brown‐black pigment) synthesis in melanocytes. Exogenous delivery of α‐MSH also can elicit tanning of the skin through the activation of MC1R. Therefore, α‐MSH and its analogs have the potential to prevent both KC and melanoma by increasing photoprotective pigmentation in the skin. The best characterized synthetic α‐MSH analog is the tridecapeptide (Nle,4D‐Phe7) α‐MSH (NDP‐MSH), which differs from natural α‐MSH by 2 amino acid substitutions.22 NDP‐MSH and other tripeptide and tetrapeptide analogs of α‐MSH are potent agonists of the MC1R in cultured human melanocytes that have wild‐type MC1R but are not active (ie, they do not increase melanin synthesis or DNA damage repair) in melanocytes that harbor MC1R variants associated with red hair.23 Given these in vitro data, it would seem reasonable to predict that non‐Hispanic white individuals with red hair, 80% of whom harbor loss‐of‐function mutations in MC1R, would not tan when an MC1R agonist is administered. However, there are reports that fair‐skinned patients and those who are carriers of red hair color alleles of MC1R have a greater response to subcutaneous injections of NDP‐MSH, as measured by changes in melanin density, than patients who have skin phototype III or greater and/or wild‐type MC1R.24 The reasons for the lack of concordance of in vitro and in vivo analyses of NDP‐MSH are not clear and could have to do with the complex genetic and environmental factors that affect human pigmentation.

A randomized controlled trial of 28 white men who received 10 subcutaneous injections of either NDP‐MSH or saline over 12 days demonstrated that NDP‐MSH reliably tanned the skin, with the peak effect occurring 1 to 3 weeks after treatment.25 However, the side effects of NDP‐MSH (which are attributed to nonselective binding to other melanocortin receptors in tissues other than the skin) include nausea, flushing, and loss of appetite. A subsequent larger randomized controlled trial of 79 male and female patients who received subcutaneous injections of NDP‐MSH demonstrated that melanin levels were increased by 41%; and, after receipt of 3 minimal erythema doses (MEDs) of UVR, epidermal sunburn cell formation was decreased by 50% in patients who had Fitzpatrick skin phototypes I and II.26 Nausea was again noted as a common side effect, occurring in 85% of patients, as was flushing, which occurred in 74%. NDP‐MSH, also called afamelanotide, is now marketed under the brand name SCENESSE by Clinuvel Pharmaceuticals (Melbourne, Victoria, Australia). In Europe, it is approved for the treatment of erythropoietic protoporphyria.27 NDP‐MSH also has been tested in patients with vitiligo, and more repigmentation was observed in those who received NDP‐MSH monthly for 4 months after UVB radiation treatment compared with those who received UVB radiation alone.28


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PortugueseMan
post Posted: Oct 30 2019, 07:45 PM
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In Reply To: royco's post @ Oct 30 2019, 05:23 PM

I have been thinking a lot about this and I will also vote for all the points on the agenda. I don't really care if those extra shares will make PW even more rich than he is now, as long as it means faster expansion of the company and its products, and a sp 5x or 10x higher than the current sp.



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LevelHeaded2000
post Posted: Oct 30 2019, 07:12 PM
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I think Australia is likely worth $15 million a year in revenue. It is awesome news, though upcoming UK and France will be considerably larger (3x, easily). It is nice though to keep adding companies to expand the income and revenue. A lot of people forget that Clinuvel still has a LOT of profits to extract from Europe.


Total profits in 2019 were 18 million. My guess is that australia revenue will mostly be profits because it's mostly marginal costs and they already have an office there, etc. So, while Clinuvel's profit % is currently about 58% of revenue the marginal revenue from Australia will likely be 80% profit. After all, things like the cost of the CEO, cost of most staff, etc, don't change just because they are shipping implants to Australia.

So, given that, Australia could add 12 million to the bottom line. That alone, excluding UK / France / USA / etc, would put Clinuvel's profit at 30 million. Clinuvel is trading at 85 P/E ratio. All things being equal once the australia income is added the PE ratio will drop to 50. Remember, that is excluding UK / France / USA and more new countries ALL of which are larger than Australia. Add in those other countries and the PE ratio could drop to < 20 very easily.

It shows you quickly the stocks fundamentals can change. My point being that Clinuvel investors are basically not counting ANY other indications in their evaluation of the company. They are solely only considering EPP.

As investors begin to account for future indications and growth the stock price will surge, IMO.


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Frogster
post Posted: Oct 30 2019, 05:49 PM
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In Reply To: royco's post @ Oct 30 2019, 05:23 PM

I agree with several of your points, but I don't see there is any overall benefit in their misremembering/misrepresentation of observable history.



--------------------
Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.
 
royco
post Posted: Oct 30 2019, 05:23 PM
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I think they thought the fda approval would not take that long hence the optimistic tga timing.

PW and cuv are not know for putting accurate timelines but for achieving 2 main milestones and all the little ones in between.
How could they have done things faster when the regulators dictate all?
In hindsight I think this was probably the shortest and most likely only path to regulatory approval.
Along the way they secured enough funding avoided a hostile take over and achieved a viable commercial plan leading to profitability, a dividend and a strong financial situation.
Bravo!

I voted FOR for all points on the agenda because I agree to award him those shares if the market cap reaches those astronomic values in just 36 Months.
5 times current valuation.
Five times.
36 months (or less)
Those extra shares also mean his commitment to the company success increases to almost unhealthy levels.

And yes, I was there in 2004 and 2005 seeing my investment dwindle and hopes fade untill the turnaround.

PW and WB are all that stand between a bright future and a lowball take over.
I opt for the bright future allthough a take over might come regardless.
Glta




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Ἀρτεμίσιον

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wpw
post Posted: Oct 30 2019, 05:08 PM
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In Reply To: Frogster's post @ Oct 30 2019, 04:26 PM

Amen

 

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Frogster
post Posted: Oct 30 2019, 04:26 PM
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In Reply To: Clinhope's post @ Oct 30 2019, 03:32 PM

From today's TGA press release:


“The submission of the scientific data on SCENESSE® to the TGA was always planned to occur after obtaining European and US approval,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.


This is a great example of the kind of behaviour from CUV which really annoys me. They are trying to rewrite history in a way that favours themselves. That statement is inaccurate.

The 2017 AGM presentation, p40, showed an anticipated TGA filing late Q3/early Q4 2018. p42 shows, at that stage, the FDA PDUFA date was expected to be Q1 2019, so clearly at some stage it was anticipated TGA submission would run in parallel with ongoing FDA consideration and NOT wait until US approval was given.

Timings change, and strategies change. I get that and don't have major issues with many of the reasons which cause delays. I'm not holding them to those particular dates, but please don't take us for mugs and claim you always planned it this way. You didn't, and any claim otherwise can only be seen as self-serving. Lodging with the TGA next year will trigger a performance clause in the Rights package they are seeking approval for, as would subsequent approval. If they'd filed on previously disclosed time frames, no such triggers would've been made. So, to me, a little more honesty and accuracy is in order since a big pay packet is linked to these claims.

I think the management has achieved something really great with FDA approval, and there is a bright future ahead for the company. PW in particular has already been handsomely rewarded for his efforts. I have no doubt PW and Management deserve to be rewarded well for any further significant progress, but I guess my view of "well" differs a bit from that of the Board. Also, some of the terms in the Performance Conditions, on reflection, are so loose you could drive a bus through them.

PW extolls the virtues of situational awareness. I'd encourage the company to develop a little more self awareness too. That means being happy, and even proud, to have achieved what they have, but please do not try and claim perfect execution and strategic vision and please recognise when your execution has varied from what you have presented to us.



--------------------
Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.

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Clinhope
post Posted: Oct 30 2019, 03:32 PM
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In Reply To: rabbitrun's post @ Oct 30 2019, 12:04 PM

So you think PW might step down if he only gets say....$100 million in 3 years?

Make no mistake, i think PW is the man to lead the ship. I'm almost certain the PC's will be passed, i just think it's obscene.



--------------------
Member of the “ALL-IN” club 2018.

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macgyver
post Posted: Oct 30 2019, 02:23 PM
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PW is turning into an animal, he’s given up the Mary Jane and is now snorting coke.👀 Expect Japan application to follow in short order. No time to waste my good man!🎩


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LJS
post Posted: Oct 30 2019, 02:05 PM
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In Reply To: rabbitrun's post @ Oct 30 2019, 12:04 PM

Just saw a doco movie on the banking fallout during and leading up to 2008 crash. Corporate greed is not good IMO but it's pretty inherent across most listed companies. Generally great rewards but no hits for poor management (as in 2008). American taxpayers seemed to foot the bill for all the flamboyance and mis- management among high flying bankers and their academic and political mates. In the case of Clinuvel, there was a time (perhaps 2010-2013) when I thought there was an element of over payment for underachievement. Currently it's pretty hard to knock the incentives based on the last two years performance. My rough figuring would give PW about 500k shares on pretty near term achievable milestones with a share price around $56AUD. (PC1 50%,4,6 and 7). If he did a bit better with the share price and achieves PC2,3 and 5, he might get another 500K shares. PW currently has about 4 million or so I think so currently worth around 120 million. If he walked tomorrow, what would the share price do? No prizes for guessing a huge drop IMO. In the next 3 years he might be afforded between $30 million and $70 million depending but at the same time the company worth could be up to between $50 and $100 per share. It's often argued from retail investors, they like Management and Boards to have skin in the game. I don't recall PW ever selling a share although I would understand at some point he might have a tax issue to take care of. I like that he is vested in the company and for the next 3 years should drive the company to further success. In the whole scheme of things, diluting the share base by a million or 2 million shares (2-4%) for PW and management does not bother me if the share price keeps rising significantly over the next three years. It is also substituting for cash incentives they could earn. At this point I imagine PW could do other things and put his feet up but I'm one who wants him to continue at almost any price. He also has credentials to put him on the radar of other organizations wanting to headhunt. Generous, absolutely, but it's only money after all and for the next new recipient of Scenesse for EPP I'm betting they don't care too much about how much PW was earning next they get a welcome dose of sunlight. In the end all shareholders get to voice a vote as the Chair stated, but the funds generally rule the outcome. Each to their own, I'll be focusing on the next cab off the rank (nice to see TGA progress finally). GLTA


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