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Clinhope
Posted on: Yesterday, 08:51 AM


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CLINUVEL EXPANDS SINGAPORE LABORATORIES
The Singapore Economic Development Board awards R&D grant to CLINUVEL’s fully owned subsidiary VALLAURIX ________________________________________________________________________________
____________________________________________________

EXECUTIVE SUMMARY
• CLINUVEL investing in further expansion of VALLAURIX R&D facilities in Singapore
• The Singapore Economic Development Board (EDB) supports VALLAURIX with up to A$547,000
• New VALLAURIX laboratories to operate under ISO17025 and GLP and open 1 July 2020 ________________________________________________________________________________
___________________________________________________

Melbourne, Australia and Singapore, 24 February 2020
CLINUVEL PHARMACEUTICALS LTD today announced that it is investing in the further expansion of its facilities in Singapore with new state of the art and expanded laboratories to open 1 July 2020. The research and development capacity of its wholly owned subsidiary, VALLAURIX PTE LTD, will be expanded through both a new biological and analytical laboratory, which will work according to both ISO17025 and Good Laboratory Practice (GLP) specifications. CLINUVEL is adding new highly skilled local personnel to its existing team and specialised technical laboratory equipment to further enhance the progress of its product pipeline.

EDB SUPPORTS VALLAURIX EXPANSION PLAN
CLINUVEL is pleased that VALLAURIX has received support of its expansion plan from the EDB with an award under their Research Incentive Scheme for Companies (RISC). This is part of the Government of Singapore’s incentives to assist Singaporean businesses to develop their research capacity to advance high valued technologies. The award is up to S$500,000 (A$547,000) over 3 years.

COMMENTARY
“As part of establishing a diversified pharmaceutical company we are injecting substantial funding to accelerate our R&D output. The decision to expand VALLAURIX’s laboratories in Singapore had hinged on the FDA’s grant of marketing authorisation in October 2019 of SCENESSE® (afamelanotide 16mg)1, since this outcome provided our team the ultimate seal of approval for the family of melanocortins.” CLINUVEL’s CEO, Dr Philippe Wolgen said. “We are steadily establishing the infrastructure of CLINUVEL providing for both organic and inorganic growth with the ultimate objective to unveil multiple offerings.”
“The economic history and achievements of Singapore demonstrate how this outstanding nation wishes to further both its technological knowhow and scientific aptitude. The Government of Singapore looks for opportunities to increase the country’s GDP through enhanced economic and scientific output and in this context, the EDB’s financial support of our innovation in new chemical entities and novel medicines is most appreciated,” Dr Wolgen said.

END QUOTE.
Emphasis by me.
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Clinhope
Posted on: Yesterday, 07:54 AM


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You guys realize that even Scenesses acceptance in the broader community in Australia, US, europe for example wouldn’t stop people from using sunscreen right?

If anything they would use less, which is awesome for all the reasons pointed out below. And yet without something revolutionary (wink wink) to apply to the skin (COUGHOTCCOUGHTSUMOYLE?) itself people will still need to resort to using sunscreen.
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Clinhope
Posted on: Feb 23 2020, 12:47 PM


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Unfortunately the two best sunscreen ingredients, zinc and titanium oxide are the ones people (in general) dislike the most because they are what cause the whiteness when wearing sunscreen.

Shame there isn't something that can stimulate our bodies to produce a substance that is a result of hundreds of millions of years of evolution and is an extremely efficient skin protectant against both UVA and UVB rays....ohhhh wait a second!
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Clinhope
Posted on: Feb 19 2020, 11:00 AM


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Just a heads-up to anyone interested. Avita has a new presentation pdf out this morning. Compelling reading to say the least. I say no more or less.
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Clinhope
Posted on: Feb 18 2020, 09:06 AM


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Not a chance, this is a person that could do some seriously impressive research on a company essentially no one cares about and was happy to do so week in week out for YEARS with minimal interaction from other Clinuvel investors. A seemingly thankless endeavour.

As far as i can tell he never showed up here and after the way the last few months played out i don't think he ever will.
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Clinhope
Posted on: Feb 14 2020, 03:04 PM


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I guess it really depends on the necessity to have the paradigm changed in the next year or so.

The fact that Scenesse will be administered to EPP patients and not the general public will mean any change will likely be "organic" as people are exposed to this news that there's a drug that allows people who are allergic to the sun to live normal lives. PW would probably be wise to inform The Cancer Council on how damn awesome Scenesse is, but he'd be foolish to overtly suggest anything about the current "slip-slop-slap" message should change.

As I've said before, even if this is used "to its full potential" wink.gif in 5 to 10 years time, and even if Cancercouncil is on-board, the public paradigm will still be one of using both sunscreen and Scenese. The beauty would be that massive reduction in the amount of toxic, polluting substance being used. Unless of course Clinuvel has a sunscreen of their own.
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Clinhope
Posted on: Feb 14 2020, 01:23 PM


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CancerCouncil/Sunsmart. They do good work in terms of research and general positive things surrounding all types of cancer in Australia. But they are the ones who will butt heads against Clinuvel unless PW can get them on his side. Which they should undoubtably be, as Scenesse is the thing which they should champion and shout from the sand-dunes as the saviour of Australians skin. (This is quite some time in the future).

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Clinhope
Posted on: Feb 14 2020, 09:53 AM


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Funny thing is that i know more about off-label prescribing in the US than here in Aus.Though it's basically the same, Dr's here can prescribe a TGA approved drug for an indication as long as there is no alternative and they monitor the patient.

I think the two biggest factors in how things will play out in Aus is the archaic view of what actually causes skin cancer, and how tight of a grip Clinuvel has on its distribution. Even if a specialist here wants to prescribe Scenesse to someone with Vitiligo for example, or some other indication which they have justification for trying, will Clinuvel allow them to purchase Scenesse?

Once TGA gives the go ahead and EPP patients start being treated I'm sure it will cause quite the stir here because it flies directly in the face of what a powerful unmentionable organization has made its money from for decades.

The deep paradigm in Australia is slip-slop-slap. That's the only answer we've had to mitigating the devastating number of people who die from skin cancer here. As a result people typically either avoid the sun all together, or expose themselves to it whilst applying liberal amounts of toxic chemicals to their skin (this is how i will refer to sunscreen from now on).

So under this paradigm which we've had for over 40 years, how is it that the people who cannot tolerate the sun at all, who when exposed to it for just a few minutes breakout in extreme burns and blisters, how is it that they of all people can take Scenesse and have deep healthful benefits whilst enjoying the sun?

Mind you, regardless of how Scenesse is played out in Australia, i can near guarantee that it will be a decade before the slip-slop-slap paradigm changes at all. Maybe Clinuvels OTC products can help with that, a big 1-2 COMBO to toxic sunscreen.
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Clinhope
Posted on: Feb 6 2020, 10:52 AM


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I don't think it changes much because i think in the Scenesse v mt7117, there are both known and unknown factors that are much more important.

I managed to find the last reference i read about dosage some a patient in the trial:
Attached Image



So it is definitely six pills per day, not just one.
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Clinhope
Posted on: Feb 6 2020, 09:18 AM


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Sorry but where did you get one pill a day from? It’s six pills a day For the tanabe trial, ive seen comments from people in the trial including the lady recently referred to here.

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Clinhope
Posted on: Feb 5 2020, 10:24 AM


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Can anyone else see the second number for the CUV sp....i swear that looks like a 5!
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Clinhope
Posted on: Feb 4 2020, 10:05 AM


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Come on guys surely it’s a combination of both the market drop and shorters amping things up.
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Clinhope
Posted on: Feb 3 2020, 09:01 AM


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So 150 working days takes us to Wednesday 2nd September 2020.

Please no extensions this time i couldn't take it.
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Clinhope
Posted on: Jan 31 2020, 06:59 AM


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For what it's worth the last round of madness in these circles finally allowed me to get passed my SS addiction. I went from checking for updates dozens of times a day to once every few days and I've never been happier. It was seriously like the Yahoo asylum had infected SS and GG.

To have what i consider two very respectable members of the Clinuvel scene act in such ways that were near polar opposite of past behaviour is completely bizarre. LH, it's in your name, yet what happened is akin to "the boy who cried wolf", you cried "MITSUBISHI TANABE IS COMING" so many times that no body cares. Whether you had an agenda or not, you sure as hell made it seem that way. Not very level-headed.

And then we've had Uho, the godfather of all things regarding Clinuvel science, spit the dummy as a result of what's happened here and someone having posts removed on GG. How he could also try to defend what was more hysteria and fearmongering than level-headed analysis completely boggles my mind.

Once you're seen as an Ignoramus there is no coming back. All your posts no matter how fair and balanced will be read with skepticism.

Best of luck to everyone.

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Clinhope
Posted on: Jan 11 2020, 05:16 PM


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Nobody except me. I called that PW would maintain the same mentality post FDA. Like i said, i wish i was wrong.

Nov 19: “ For what its worth I don’t think PW will falter from his slow and steady approach. I’m expecting basically more of the same, or at least a very cautious approach aiming for consistent year on year growth. “
https://boards.sharecafe.com.au/index.php?s...c=27&st=810

I think it comes down to PW and the team believing/knowing that the best way to make inroads is to focus more on actually doing work than promoting the business.

Yes its hard. No I don’t think they are perfect. I know they’ve “promised“ so much and fell short of some of those. But we all know that what has been achieved so far is extremely rare and what is to come will make that look mediocre. Special achievements are never done by doing what every other idiot does.
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Clinhope
Posted on: Jan 10 2020, 12:21 PM


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Slow, steady, consistent growth, I’m sure PW has it tattooed somewhere.
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Clinhope
Posted on: Jan 10 2020, 07:10 AM


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As i said earlier it crossed my mind that Clinuvel had something to do with that report. If so, don't you think it completely supports Clinuvels future endeavours? Remember the OTC line and other "products" in development (a "sunscreen")... which as far as i can tell are suppose to be a new age of cosmetics and if based on Scenesse i have no doubt that could be true.

Aside from what the future holds for clinuvel products, the article is absolutely correct, i.e regardless of how effective Scenesse is at providing U.V protection, DNA repair, anti-inflammatory etc it probably should never be the sole aspect of sun protection. People who use Scenesse still need to consider the same questions regarding sun protection, how long can i spend in the sun? What is the UV index? ETC.

So hopefully Scenesse is just a very good safety net that will prevent massive amounts of DNA damage from too much sun exposure without all the toxic chemicals in todays sunscreens that poison both humans and the environment and Clinuvel has developed a range of products to bolster peoples protection from the sun.
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Clinhope
Posted on: Jan 9 2020, 10:44 AM


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Yeah Billy sadly it is mostly wishful thinking. Although if they don’t outlay 2020 in some way by the end of January I’ll be surprised and extremely disappointed. The amount of emphasis PW has placed on 2020 as being the year where rubber hits the road is long and deep, possibly since the 2017 AGM?

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Clinhope
Posted on: Jan 8 2020, 05:48 PM


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It did cross my mind. Ive also noticed a number of web pages mentioning Scenesse since January 1st 2020. Only obscure pages in foreign languages that arent worth putting here. But it seems like the pot has been stirred gently.

Lets hope something of positive significance comes from PW by the end of January.
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Clinhope
Posted on: Jan 7 2020, 06:10 PM


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I just browsed a study posted by Uho on GG and it nicely mentions afamelanotide as a possible alternative for sunscreens as a photoprotectant.

https://onlinelibrary.wiley.com/doi/full/10.1111/jdv.16030

QUOTE
Systemic photoprotection can also be achieved by drugs. Afamelanotide (Scenesse®) is a first‐in‐class synthetic analog of α‐melanocyte stimulating hormone, indicated for persons with inherited cutaneous porphyrias such as erythropoietic protoporphyria (EPP) and X‐linked protoporphyria (XLPP) characterized by acute photosensitivity, resulting in reduced quality of life. Afamelanotide mimics the naturally occurring hormone to increase skin pigmentation by increasing melanin production in melanocytes, resulting in increased sunlight tolerance in patients with EPP.56
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Clinhope
Posted on: Dec 30 2019, 10:09 AM


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Seems like a possible collaboration partner if not an acquisition for Clinuvel. This is pure speculation mind you.
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Clinhope
Posted on: Dec 13 2019, 04:10 PM


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I was looking at another persons FB posts who has EPP and was part of the MT 7117 study. He made a comment to the effect of "i heard the other one is a little better", referring to Scenesse being better.

If only we could get these people exposed to Scenesse, i don't think they'd even look twice at anything else.
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Clinhope
Posted on: Dec 13 2019, 02:45 PM


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Nothing new, just once again reaffirming that PW is a Contrarian in the best possible way. Much like most of us here are.
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Clinhope
Posted on: Dec 13 2019, 07:14 AM


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Stephen Hahn elected to head FDA. https://www.marketwatch.com/story/five-thin...-fda-2019-11-21
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Clinhope
Posted on: Dec 6 2019, 12:28 PM


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I mean to a point how much can we expect them to have ready to go. I think the general consensus here was that the FDA approval was both the event horizon and the river dam. There would only ever be a certain amount of pre-approval work that they could do. Majority of the time involved would be for getting approval and the rest would be planning the work to be done. And now post approval it is the time to actually implement that plan.

Give them a little bit more time yet before we throw the baby out with the bath water. 2020 is our year.
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Clinhope
Posted on: Dec 3 2019, 11:52 AM


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I just want Madman back to see what he's been up to!
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Clinhope
Posted on: Dec 2 2019, 06:52 PM


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So the question remains. If a drug can be established as different and be approved for the same indication, does it also need to be "better" than the other drug to gain approval?

It doesn't make sense to me that the FDA would approve a different drug for the same indication if the new drug is inferior in some way that negatively affects the patients?
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Clinhope
Posted on: Dec 2 2019, 09:19 AM


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In a good way, PW has just told me that after summiting the Mount Everest of approvals we face another one just as high although this time we are locked in to fall no lower than the previous mountain.

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Clinhope
Posted on: Dec 1 2019, 06:44 AM


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One of the best practices for strong investing is to always think of counter arguments ESPECIALLY when you have a “dream” investment.

LH posts of late have raised some great counterpoints to what my Clinuvel investment story had been and furthermore seemingly called other posters here to find some great info.

Everyone just take a week off and chill TF out!
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Clinhope
Posted on: Nov 28 2019, 03:44 PM


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Yep since early last year. It reminds me that Vallaurix has been supposedly developing complementary products to scenesse since 2014. I pray that in the first half of 2020 those 6 years of hard work and development are shown in some way to us.

Wolgen and Biljdorp are no fools. "Everything" is ready to be implemented come 2020.
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Clinhope
Posted on: Nov 26 2019, 06:02 PM


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As lucky as we are to be early investors for Clinuvel we would be 1000 times more UNLUCKY should MT-7117 turn out to be an approvable drug!!!
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Clinhope
Posted on: Nov 26 2019, 06:01 PM


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Double.
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Clinhope
Posted on: Nov 22 2019, 12:08 PM


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If anyone had seen my post a few days back they would've seen the obvious reason why CUV is being shorted.
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Clinhope
Posted on: Nov 19 2019, 06:27 PM


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Can't disagree with what you've said, behind you all the way. It's just a well worn track, and PW saying something along the lines of "business as usual" during the last Commsec interview makes me think this way.

Again, it would be a breath of fresh air for him to open up and explain things. FINGERS CROSSED for that tomorrow.
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Clinhope
Posted on: Nov 19 2019, 04:56 PM


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For what its worth I don’t think PW will falter from his slow and steady approach. I’m expecting basically more of the same, or at least a very cautious approach aiming for consistent year on year growth.
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Clinhope
Posted on: Nov 17 2019, 07:13 PM


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To summarise the video it shows the impact that algorithmic trading conducted by investment bank brokers can have on suppressing and significantly lowering a stock price.

Showing that through 2012-2015, ASX company “kingsgate” was negatively affected by algorithmic traders who orchestrated the lowering of the s.p via countless small trades (under $500 AUD) causing an out of proportion downtick in the stock price. Resulting in an average of 0.74% of selling trades being responsible for 59% of all price falls over 4 yrs of trading.
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Clinhope
Posted on: Nov 17 2019, 06:04 PM


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Well this is interesting when considering the last few years of CUV, shorters and the s.p.

Not suggesting it is the same thing as described in the video, but it is interesting.

https://youtu.be/GQjH49vIABU
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Clinhope
Posted on: Oct 30 2019, 03:32 PM


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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.
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Clinhope
Posted on: Oct 30 2019, 01:13 PM


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Holy moly.

https://www.asx.com.au/asxpdf/20191030/pdf/...1tbqxzwgl7s.pdf

Australian Therapeutic Goods Administration (TGA) enables priority registration pathway
• Target timeframe for priority review is 150 working days from submission of application
• CLINUVEL intends to submit scientific dossier in Q1 2020
• SCENESSE® to treat patients with erythropoietic protoporphyria (EPP) in Australia
• TGA granted SCENESSE® orphan drug designation in 2010
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Clinhope
Posted on: Oct 30 2019, 11:18 AM


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I mean just from a social perspective I’d vote against them. Four years of hard arduous work does not warrant an obscene amount of money. The world has enough of a problem with gluttonous wealth accumulation and greed.

I’m fully aware of the slight hypocrisy of this coming from someone who’s done very well off this investment. But the differences are worlds apart, from a mora standpoint I can’t vote for this despite how much me and my family would benefit.

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Clinhope
Posted on: Oct 30 2019, 11:03 AM


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https://www.asx.com.au/asxpdf/20191030/pdf/...1r7wj3jzyc3.pdf
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Clinhope
Posted on: Oct 23 2019, 09:32 AM


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Does anyone else think it possible that management is simply pacing the rollout in Europe to ensure a steady growth trajectory? When i think of Wolgens adversity to having the light shone on the company, his mostly unorthodox ( but refreshing ) approach to steering this ship and now knowing that they didn't pursue France makes me wonder if they were basically happy with the amount of profits projected and were willing to leave it till a later date.
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Clinhope
Posted on: Oct 18 2019, 02:57 PM


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So the gist of it is that while shorting and whatever tools they are using are legal, using them to manipulate a stock price isn't?

Makes sense.
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Clinhope
Posted on: Oct 18 2019, 02:02 PM


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@ Johnny H and the shorting complaint. Is there actually some legal ground to stand on? I was reading a random article only yesterday and the CEO of another Aussie company referred to his company being shorted as though it was an inevitable aspect of being a smaller stock with low volumes and speculative investors:

QUOTE
The capital raise in July was $1.70. At that point your share price was $2 dollars, now it’s $1.35, so all those people who gave you money then are under water.

I understand that aspect and I suppose from us, really, one of my jobs is how do I grow the business and also keep those investors happy, which is obviously – they’ve shown us the support towards our industry and what we’re growing as well. Unfortunately we’ve had a couple of situations where we’ve got hit by some shorters – and I’m not making any sort of excuses here – but we had the founder shareholder’s stock came out at that escrow in September and obviously there was a downturn around those expectations. Successfully been able to manage that with existing founders as far as that escrow stock, we’ve actually worked on an agreement not to just sell-down and damage the market further. But obviously that caused a bit of a downfall.

You got hit by some shorters, did you? Is that what happened?

Pretty much. I suppose, unfortunately in Australia, as soon as they know the stock’s coming out of escrow of the founders, that’s generally ripe position for that bit. Also, because we fall into what we call that 3D printing sector as well, which tends to be – there’s a lot of hype around 3D printing about overvaluation of companies, so they sort of play off that sort of reality check


So this and other similar situations with other companies gave me the impression that it was similar to what's been happening with CUV and that there's nothing to be done about it?
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Clinhope
Posted on: Oct 11 2019, 12:34 PM


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Has everyone seen this, i don't think anyone has posted it.

Prescribing information: https://www.accessdata.fda.gov/drugsatfda_d...0797s000lbl.pdf

Key points:

*SCENESSE should be administered by a healthcare professional who is proficient in the subcutaneous implantation procedure and has completed training prior to administration.

*Administer SCENESSE subcutaneously every 2 months

*A regular full body skin examination (twice yearly) is recommended to monitor all nevi and other skin abnormalities.

*Maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to EPP. (I think this will be the case anytime Scenesse is used in the future, hopefully a reduction in sunscreen use replaced by Scenesse and protective clothing etc.).

NDA approval: https://www.accessdata.fda.gov/drugsatfda_d...rig1s000ltr.pdf

*CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, submit the
content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
the FDA automated drug registration and listing system (eLIST)

*Submit final printed carton and container labeling that are identical to the carton and container labeling submitted on October 3, 2019,

*ADVISORY COMMITTEE
Your application for Scenesse was not referred to an FDA advisory committee because the application did not raise significant safety or efficacy issues in the intended population

*Therefore, based on appropriate scientific data, FDA has determined that you are required to conduct the following studies:
3726-1 Conduct a thorough QT clinical study to adequately characterize the effect of afamelanotide on cardiac repolarization.

The timetable you submitted on September 30, 2019, states that you will conduct this study according to the following schedule:

Draft Protocol Submission: 10/2020
Final Protocol Submission: 01/2021
Study Completion: 11/2021
Final Report Submission: 02/2022

Conduct a prospective, longitudinal, registry based observational exposure cohort study to collect information on long-term safety of afamelanotide in patients with erythropoietic protoporphyria (EPP) in the United States. Patients will be followed for a minimum of eight years from initiation of treatment with afamelanotide.
The primary adverse events of interest are:
 skin cancer (melanomas and non-melanomas)
 administration/injection/implant site reactions

Secondary adverse events of interest are:
 changes in pigmentary expressions
 pregnancy outcomes (including major birth defects and other adverse
pregnancy outcomes such as spontaneous abortions, stillbirths,
preterm deliveries, and small for gestational age)
 exposure during lactation and adverse reactions in breastfed infants
 implantation device malfunction or failure.

The timetable you submitted on October 7, 2019, states that you will conduct this study according to the following schedule:
Draft Protocol Submission,: 10/2019
Final Protocol Submission: 02/2020
Study Completion: 06/2030
Interim Report Submissions: 06/2022, 06/2024, 06/2026, 06/2028
Final Report Submission: 03/2031





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Clinhope
Posted on: Oct 11 2019, 11:27 AM


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Just more coverage, nothing we didn't know.

http://www.pharmabiz.com/NewsDetails.aspx?...18684&sid=2
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Clinhope
Posted on: Oct 10 2019, 03:13 PM


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Never mind
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Clinhope
Posted on: Oct 9 2019, 04:01 PM


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Ehhhhh...he's just thanked two "families" so far. I think these families are closer to the Rockefeller's than us lot.
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Clinhope
Posted on: Oct 9 2019, 02:44 PM


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https://finance.yahoo.com/news/australian-d...-004516207.html

https://www.theage.com.au/business/markets/...xm.html?ref=rss
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Clinhope
Posted on: Oct 9 2019, 12:18 PM


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What time did you start? ahahaha
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Clinhope
Posted on: Oct 9 2019, 10:11 AM


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Clinuvel site is updated. https://www.clinuvel.com
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Clinhope
Posted on: Oct 9 2019, 09:49 AM


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So how long till we can see the effect this fantastic news has had on our Short friends on shortman.com?

P.S...do not go to shortmen.com by accident.
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Clinhope
Posted on: Oct 9 2019, 09:34 AM


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I mean i'm currently drooling at the action (not looking at you macgyver haha). But did anyone notice the reason why the second EPP trial was so much more telling to Scenesses effectiveness vs the 1st trial?

They shortened the relevant hrs of sunlight from 10am - 6pm in the 1st study to 10am - 3pm in the 2nd. It was also longer, and days where the patient spent time in the shade as well as sun were not counted. Very clever (no sarcasm). "The primary endpoint was the total number of hours over 270 days spent outdoors between 10 am and 3 pm on days with no pain for which “most of the day” was spent in direct sunlight. "

Also, I'm glad to see the FDA putting Clinuvel on their Press announcements page, they seem selective as to what gets put on there: https://www.fda.gov/news-events/fda-newsroo...s-announcements
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Clinhope
Posted on: Oct 9 2019, 04:39 AM


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Posts: 1,070

Woohoo!!!!!!!!!!!! As i wake up in the cold dark morning at 4:43am i spill my glass of orange crush cordial next to the bed, so angry, a minute later i scroll through SS to see “ FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder” it really says it all. I rush out to the living room to do a silent victory dance and i still feel like im dreaming.

So many years of checking updates on Clinuvel, so many hours of hard work to be able to buy the shares that would hopefully secure mine and my families future. And yet my story is nothing compared to the stories of people with EPP and all the other diseases Scenesse will effectively treat. Congratulations to them.

Lastly congratulations to the Clinuvel team.

Well done to everyone here, im sure the Sharescene forum will be just as critical to us all over the next ten yrs as it has been in the last.

Time for another victory dance!!!!!!!
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Clinhope
Posted on: Oct 8 2019, 11:04 PM


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You’re sure it’ll be announced after 4pm EST? I can go to bed now, have a sleepless night and “wake up” at 6:00am here in Aus?
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Clinhope
Posted on: Oct 8 2019, 04:14 PM


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The combination of saying bye bye to the shorters and the increase in exposure once word gets out there's a Aussie biotech that just gained FDA approval I'm guessing a hovering of $35-45 over the next month.

For some reason I'm now more interested in attending the AGM post approval.
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Clinhope
Posted on: Oct 7 2019, 08:12 PM


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Is anyone in Aus staying up tonight in case the news comes a day early?
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Clinhope
Posted on: Oct 7 2019, 09:06 AM


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Wolgens contract renewed till 1 July 2022.

Good news? I think so, it was dumb to have the person who orchestrated (hopefully) the company's direction and approval and then to have them leave just as the rubber hits the road. A handover to another CEO would not speed things up in the short to mid term.
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Clinhope
Posted on: Oct 2 2019, 06:06 AM


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Multi-billion dollar sunscreen industry?
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Clinhope
Posted on: Oct 1 2019, 10:38 PM


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I have no doubt that the FDA turning it ears to the voices of patients is primarily, if not solely (at least for now), referring to EPP sufferers and Scenesse.
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Clinhope
Posted on: Sep 27 2019, 08:55 AM


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My comment was in response to “endymion96” asking if somebody can explain the logic of the shorters and when you realise that the overwhelming methodology of global economies and financial systems are not based on logic, it starts to paint the picture of why someone (running an algo or not) would short CUV. Just look to fractional reserve lending, modern portfolio theory, derivatives, QE, QT, record stock buybacks etc. All these things come together equalling a highly speculative, highly manipulated system. These economies are by no means a “free markets”, CUV being shorted is just another spec of sand in that manipulated system.

So believe what you will and keep the lame insults coming.
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Clinhope
Posted on: Sep 26 2019, 10:07 AM


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Ahuh, because there isn't a $1.5 quadrillion global derivatives debt, the GFC wasn't caused by writing off sub-prime debts and the reserve banks don't create money out of thin air. laugh.gif

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Clinhope
Posted on: Sep 26 2019, 08:52 AM


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Their logic is one based in a world where governments and banks play with global economies like it’s a game of monopoly.

I really don’t think that’s being melodramatic in the slightest. And on a smaller scale like these idiot shorters, just look to the overwhelming investment philosophy of “modern portfolio theory” which allows this game of monopoly. No offense to any fellow small fry participating in the game to try and get ahead.

11 days at most before all our Christmases come at once. Anyone got some good celebration plans they wanna share?
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Clinhope
Posted on: Sep 24 2019, 03:26 PM


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Johnny is that $120 AUD or USD?
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Clinhope
Posted on: Sep 24 2019, 11:50 AM


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Haha yeah that’s fair enough... but as it is now I’ll be happy with just getting approval and being at only $30AUD.

This is like having the winning lottery ticket but not knowing whether the lottery board will GRANT you the money!

“He does have all six numbers and the powerball...”
“Nah we’ll just let him sweat for a couple weeks 😜”.
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Clinhope
Posted on: Sep 24 2019, 08:21 AM


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Surely with approval we’ll be back to $30-40 within a month. A huge upturn in awareness from approval and the release of pressure from the shorts will make the difference.

Despite my post saying we should all appreciate the position we’re in etc etc, I’ve gotta say I’m finding the wait pretty damn tough.
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Clinhope
Posted on: Sep 18 2019, 04:44 PM


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Ok, that's it. Can someone please explain to me how CUV and CLVLY are almost always in lock step. If some algorithm is playing fiddle with CUV shorting, how is it that it once again, as has been the case for years now, we have the CUV price close to within a few cents of the equivalent U.S CLVLY closing price?!

I can understand it would be within say 5% of each other would be "natural", but this is something else.
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Clinhope
Posted on: Sep 13 2019, 10:12 PM


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For what it's worth, approximately 24 days out from FDA handing down their decision, i just want to say to all the CUV long termers that we are so close to the thing we've been waiting so long for, but we still shouldn't lose sight of where we are and what it will be like post FDA decision.

America is a completely different beast compared to Europe and on top of that the company is poised to completely spread its wings. The work that remains ahead of the company is surely daunting enough even if it were just going into the US with EPP. But add on Vitiligo, paediatric, XP, OTC products, CUV9900, VLX001, Australia and Japan and you have a future that will be both turbulent and rewarding.

My point is, as frustrating as it is to see morons playing games with Clinuvel, try and appreciate the great investment you're involved in and be prepared that post October 6th, things may still be just as frustrating sitting at $50, than $23.
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Clinhope
Posted on: Sep 2 2019, 12:15 PM


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https://apple.news/AJv7CDXiLRYSyUNLeqED2Uw
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Clinhope
Posted on: Sep 1 2019, 10:09 AM


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The systemic benefits of Scenesse seem to be completely different with brem. I.e, Scenesse is still king regardless of being second to the starting line.


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Clinhope
Posted on: Aug 28 2019, 09:23 AM


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It's possible that they don't have the sh!te logo there because how would you present it without spending a lot more money. The illuminated "C" is much simpler and ties in nicely with the "light and life" conference.

SADLY...the goddess and Frilly duo may still be lurking around in the background.
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Clinhope
Posted on: Aug 26 2019, 11:38 PM


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I get your frustration, but i was relieved when i read this:

About 1% of patients treated with Vyleesi in the clinical trials reported darkening of the gums and parts of the skin, including the face and breasts, which did not go away in about half the patients after stopping treatment. Patients with dark skin were more likely to develop this side effect.

Not quite the same as Scenesse right?
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Clinhope
Posted on: Aug 23 2019, 10:33 AM


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I was looking for companies that I managed to find some other interesting cases that received an extension but are a little bit different.

Eliquis by Bristol-Myers Squibb Company and Pfizer.

In March 2012 they received the three month extension.

By late June 2012 they received a CRL!

Late September 2012 FDA accepts resubmission.

December 28th 2012 FDA approves Eliquis.

Bivigam by Adma Biologics did the same with an extension, CRL due to "FDA running out of time to review their extensive submission package."

So there are two companies that seemed to be in a very bad situation and received extensions and CRLs and went on to be approved.


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Clinhope
Posted on: Aug 21 2019, 08:31 AM


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I get your point but I’m just trying to get the attention of people that maybe aren’t as interested in this than the usual crowd.

Echo chambers are the death of truth.
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Clinhope
Posted on: Aug 20 2019, 09:30 PM


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Hopefully my post about the cash ban and the few scraps that have appeared in the MSM have got some peoples attention on this forum.

If any of you who think the "powers that be" have gone and are going too far with their monetary policies please sign this petition. It would be great if more people would contact their local members but i understand not everyone sees this the same as i do.

CASH BAN CHANGE.ORG PETITION

This is a battle against international conglomerate banks like HSBC who are petitioning the government to lower the amount to well below $10,000. They have vested interests in seeing this through.

These banks, governments and financial institutions play monopoly with real peoples livelihoods and lives. NO MORE. The next GFC will come because of these scumbags and everyday people will suffer. They are vying to set up the monetary policies around the world so that they can keep playing these games!

CASH BAN CHANGE.ORG PETITION
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Clinhope
Posted on: Aug 18 2019, 09:29 PM


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Because it is an event horizon. Our future relies so heavily on the outcome of the FDA decision that thinking beyond that point is as much speculation as trying to answer what will the world be like once General Artificial Intelligence is created? We can guess and we can prepare for likely scenarios. But ultimately, the answer to what action we take or the outcome of our future will only be unveiled when we reach the event horizon.
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Clinhope
Posted on: Aug 17 2019, 10:17 AM


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QUOTE
Final concordant and discordant regulatory outcomes

Further to the above resubmissions and reexaminations of applications, we compared final regulatory outcomes. If an application was not resubmitted/reexamined by an agency, the initial outcome was also considered to be the final outcome. By this accounting, the proportions of applications finally approved by the EMA and the FDA were similar (93% and 92%, respectively). Resubmission/reexamination of initially nonapproved applications increased the concordance between the agencies to 98% (105/107) of applications


Very nice. Interesting that the FDA has a slightly higher non-approval vs the EMA. I'd like to see if there is a difference (probably not statistically significant) of approval ratio for those who get EMA approval 1st and vice versa.
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Clinhope
Posted on: Aug 8 2019, 03:37 PM


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While we are all quietly suffering i want to raise a critical issue which i think affects all of us, even those who aren't in Australia. Despite my last rant only receiving the applause of crickets, here we go.

As of Monday the 12th August 2019 the Australian Government will introduce a bill said to help address illegal money laundering and tax fraud. A limit on cash transactions of $10,000 and above will be introduced January 1st 2020.

The truth is that this is the first step toward the government/RBA introducing deeply negative interest rates of -3% or more to appease the desires of the IMF who believes having a transition to mostly cashless economies with "deeply negative interest rates" on a global scale is the only way to stave off the impending global crisis. Which btw is a result of the astronomical debt bubble initiated post 2008 GFC, by major banks and governments around the world which continues to this day.

IMF:
QUOTE
The experience of the Great Recession and its aftermath revealed that a lower bound on interest rates can be a serious obstacle for fighting recessions. However, the zero lower bound is not a law of nature; it is a policy choice. The central message of this paper is that with readily available tools a central bank can enable deep negative rates whenever needed—thus maintaining the power of monetary policy in the future to end recessions within a short time. This paper demonstrates that a subset of these tools can have a big effect in enabling deep negative rates with administratively small actions on the part of the central bank. To that end, we (i) survey approaches to enable deep negative rates discussed in the literature and present new approaches; (ii) establish how a subset of these approaches allows enabling negative rates while remaining at a minimum distance from the current paper currency policy and minimizing the political costs; (iii) discuss why standard transmission mechanisms from interest rates to aggregate demand are likely to remain unchanged in deep negative rate territory; and (iv) present communication tools that central banks can use both now and in the event to facilitate broader political acceptance of negative interest rate policy at the onset of the next serious recession.
IMF FRAUD

This is exactly the same type of sneaky tactics the US, New Zealand, EU and Australian governments used to introduce the "Bail-IN" back in 2014. Both that and the "war-on-cash" that we are seeing now will be changed slowly, bit by bit, so as few people as possible are aware of the real reasons behind them.

The IMF has point blank stated that the only way to counter the next GFC is to drop interest rates into the negative territory, thereby causing banks and other institutions to drop their rates and thereby making common folk PAY TO KEEP MONEY IN THE BANK. No one in their right mind would do such a thing, so they are expecting people will increase the consumption and investments which will then stimulate the economy. Great! Except you still have banks conducting trillions of dollars of derivative gambling and governments conducting trillions of dollars of Quantitative Easing increasing the global debt further. Like putting a bandaid on an atomic bomb.

They are pretending this is an innocuous change aimed at finding the bad guys, the truth is they are setting it up so that when the system collapses, it is the common people that suffer and not the banks.

A great resource for information about this is John Adams website: John Adams submission letter

Summary videos: ScoMo Declares War On The Australian People
Cash Ban Lies

For any aussies out there, we can no longer afford to brush this kind of thing off without standing up for ourselves.
PLEASE, look into it yourself and write to your local MP and the treasury (Blackeconomy@treasury.gov.au) stating your concerns.


Please take a little bit of time to look into it and don't label this as being just another baseless conspiracy theory.
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Clinhope
Posted on: Aug 6 2019, 02:49 PM


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I hope my prediction of the whole global economy going to hell in a hand-basket just before approval wasn't right.
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Clinhope
Posted on: Aug 5 2019, 10:41 AM


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Looks like they want to and will crack the $30 mark. Wankers.
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Clinhope
Posted on: Aug 4 2019, 11:06 PM


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And these kinds of positive effect we see from a-MSH come about during systemic dosing, aka what occurs with the implant, or is it applied locally somehow?
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Clinhope
Posted on: Aug 4 2019, 10:20 AM


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Posts: 1,070

Punk, a-MSH aren't Melanin injections, right? Unless that's what they're referred to as, i thought melanin injections were something else. Is it possible that even as a dermatologist she has absolutely no idea what she is talking about?
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Clinhope
Posted on: Aug 1 2019, 05:04 PM


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Posts: 1,070

Clinuvel played ignorant because they never thought a plucky SC member would invoke the FOIA and uncover such critical information?
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Clinhope
Posted on: Jul 30 2019, 10:04 PM


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Posts: 1,070

Anyone have an idea why the PDUFA is set for SUNDAY? Seems pretty dumb to set it for a weekend and not a work day.

Am i missing something or it just doesn’t matter?
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Clinhope
Posted on: Jun 13 2019, 08:47 AM


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Posts: 1,070

He thinks UBER is cheap! What an idiot, it’s a massive speculative buy if UBER ever turns a profit after they get their autonomous fleet. Theyve even resorted to Elon Musk like baseless spruking with their “autonomous flying taxi service” down in melbourne. And no competition? He is demented, just every single car manufacturer that can build a fleet off the first company to achieve level 4 autonomy and sell a autonomous taxi service.

So at the very point when Uber starts clearing their massive debt with full autonomy they lose all competitive advantage because everyone will crack the code soon after.
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Clinhope
Posted on: Jun 9 2019, 01:57 PM


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I'd be in. If we get approval it will be worn with pride.
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Clinhope
Posted on: Jun 8 2019, 11:32 AM


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I’m not saying you are wrong, all i know is that the legislation leaves it open for banks to take customers money. The government guarantees to pay back the money, but this is still a highly immoral situation. It does nothing to address the real problem of banks being gambling houses and playing poker with their customers money. My understanding is that theyve done this so theres no bailouts like in 2008. Bailouts that happened because of sub-prime debt repackaging. Something which is magnitudes WORSE since 2008. Australias banks alone have ~$60 TRILLION in derivatives debt and JP Morgan alone has nearly that much!

This legislation is palmed off by most people, that will never happen they say. The truth is theyve been playing us like puppets for years.

And im not saying this because im exposed, i dont think i am. My cash deposits are minimal so unless they can sell my CUV shares and take that then i should be ok (fingers crossed).
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Clinhope
Posted on: Jun 7 2019, 10:57 PM


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Just a quick post about the totally underhanded plot to destroy any notion of a free market. Reserve banks, governments and commercial banks rape and pillage the worlds economies and leave their citizens with the charges.

The ability for banks to seize the publics deposits to stave off a collapse has been implemented more or less secretly around the world and behind our backs.

If you’re unaware of this issue, please do some reading and sign the petition.

https://cecaust.com.au/stop-bail-in-petition
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Clinhope
Posted on: Jun 7 2019, 12:08 PM


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I was just looking at the next ASX 200 rebalance, it should be on the 21st June right? Announcement being the 3rd friday of June...
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Clinhope
Posted on: Jun 4 2019, 05:50 PM


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If it ever drops below $15, maybe then.
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Clinhope
Posted on: Jun 3 2019, 05:33 PM


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Once bitten twice shy. When i read about the delay all of the feelings of old came back, paranoid conspiracies about big pharma putting the pressure on to delay a paradigm altering drug.

I understand the idea that this delay seems to bolster the chance of approval but it's still gut wrenching .

So if we get approval this will be a fast track decision of just shy of 9 months.
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Clinhope
Posted on: Jun 1 2019, 07:23 AM


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He's still around. He's got a captive audience on a remote island somewhere.
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Clinhope
Posted on: May 31 2019, 01:17 PM


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@Alaaf, thanks for sharing your story. I think you can see the appreciation for your earnest words by all the thanks from fellow Clinuvelians. It really demonstrates how lucky we all are, but especially so in your case. Not only having found a potential treatment but also having friends that respect you enough to listen to your advice and invest in Clinuvel.

Well done. All the best.
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Clinhope
Posted on: May 29 2019, 04:33 PM


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Posts: 1,070

Thanks to anyone who replied to my post so far. I find it reassuring that people with such great outlooks on their fortunate positions are making similar life choices to mine.

If i start my own Investment fund in a few years i'll know where to look for backers. wink.gif
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Clinhope
Posted on: May 29 2019, 02:16 PM


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LJS, absolutely. As i've mentioned here before i didn't take the opportunity to share the money i had, to do the things with my family that i wanted to do. Now i will have that regret for the rest of my life. I don't want to repeat that again. I've planned and forecast countless times in excel the varying scenarios for share price, number of CUV shares, expenses and income (or no income) and should i play my cards right there is no NEED to work out of necessity to "survive". Having said that i realise the need to work comes from both a sense of personal achievement and giving back to society (more than just taxes).

@THEG1000, that's great to hear. It's entirely possible i'll have to go back to work in a few years if things don't turn out well. But i've got the sack of cash and I'm running with it as fast as i can. I've been studying for the last 6 years in varying ways, taken the last year off from Uni and i'm currently studying investing to try and make a small income seperate to that of CUV. Hopefully within a few years i'll be able to stop selling CUV as an income source.

@seeva22: yep i am hungry my friend. Hungry to enjoy life and hungry to not let it all go to waste. i'm using the next few years as a way to transition (why do i hate that word now i wonder....) into finding out what the rest of my life will be about. It's 50k. Small amount left on a car loan, renting an apartment. Sell a decent parcel every month to live off of and help family when i can.
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Clinhope
Posted on: May 29 2019, 11:44 AM


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Just because i have no one else to talk to about this and you guys are the only ones who can relate to my situation, I'm wondering if anyone hear is considering early retirement?

I was walking through my "retirement village" AKA sleepy Sydney suburb and got a few questions as to why i wasn't working. My studies are on hold for this year but that is the only answer i could give. Being in my mid 30's i don't know if I'm shooting my future self in the face.

Most people here would have near the amount of shares i have. The smallest i've seen mentioned was 20,000 shares. Still a fortune even at todays s.p.

As we talk about taking profits, has anyone else given up their day job to live off the CUV fruit?
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Clinhope
Posted on: May 28 2019, 05:59 PM


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It is a positive "event horizon" for me. All i know is that the outcome will more than likely be positive. What that positive will look like exactly is completely unknown for so many factors like "Newtocli" just mentioned.

In general we all know the broad investor market buy and sell on rumours which could work for or against us. The s.p might shoot up to $70 for arguments sake and then drop down to $45 on rumours of slow implementation (as a made up example). Or it could be pushed up to $150 on news of specialist clinics ready to go, vitiligo, Australia, Japan not far behind and paediatric and topicals coming online in the next year or so.

WHO KNOWS. It's all a dream.
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Clinhope
Posted on: May 24 2019, 10:57 AM


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Yeah baby $33.04!!!
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Clinhope
Posted on: May 20 2019, 11:24 AM


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VLRX001 (a topical) is touted as being a treatment initially used in combination with Scenesse for the treatment of vitiligo. Suggesting to me that the topical is mostly localised in effect.

Clinuvel also alludes to the 2nd generation melanocortins as systemic and topical. If topicals turned out to be systemic in any major way then it's a strange distinction in the way i see it.

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Clinhope
Posted on: May 20 2019, 10:03 AM


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Strong start out of the gates.

Attached Image

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Clinhope
Posted on: May 20 2019, 09:06 AM


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In regards to the implant, a majority is absorbed by 48 hrs, 90% in 5 days, plasma levels undetectable by day 10.

Should be an interesting day of trade!!!

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Clinhope
Posted on: May 17 2019, 09:58 PM


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A small bit of coverage on yahoo finance.

https://au.finance.yahoo.com/news/insiders-...-040459461.html
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Clinhope
Posted on: May 17 2019, 09:20 PM


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Posts: 1,070

The other one ive taken a small position in is Allegra Orthopaedics. Mentioned on this board a while ago, i looked into it and it looks very promising. Though the stock barely trades and news is none existent. But the results ive seen look quite promising.

Thanks Telix, I’ll have a look.
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Clinhope
Posted on: May 17 2019, 10:31 AM


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$31.405

And yes i will be posting the highs when i catch them.
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Clinhope
Posted on: May 17 2019, 10:15 AM


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Just hit $31.3 biggrin.gif
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Clinhope
Posted on: May 14 2019, 08:01 PM


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Some of the people Clinuvel follows are a bit disconcerting:

https://twitter.com/Licuwangxiaoyua
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Clinhope
Posted on: May 8 2019, 08:56 AM


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QUOTE
The EUMelanin stimulated by Scenesse is literally the most effective and efficient “sunscreen” that we know of. Chemical creams for photo protection are ancient technology and the health risks (many are only just coming to light) that are associated with using them are outrageous in comparison to our safe and effective implant.


Absolutely. What I'm saying is that while that is true, from a public health organisation perspective such as the FDA or the Cancer Coucil in Australia is will be a decade or more before they ever ease off on the sunscreen and clothing message to prevent UV damage. It is also likely that Clinuvel will therefore support such a message, hopefully with their own OTC products with sunscreen incorporated.

QUOTE
It might seem crazy in 2019 that chemical suncreams will be rejected for Afamelanotide patches creams implants pills even, but why would you lather yourself in these ineffective chemical soups that have the potential to cause all sorts of issues within the body if you had a super safe and effective alternative? ]


I think Scenesse shouldn't be relied upon as the stand-alone sun protectant. Yes it is light years ahead of anything we currently have, but sunscreens will still have a time and place to be used in conjunction with Clinuvels other products. In that article it said that sunscreens were initially popular for use on holidays and for certain peak times of sun, whereas now it is encouraged everyday all day. Maybe those patients using Scenesse will go back to using sunscreens at the peak UV index and sun exposure periods.

It's all very speculative to forecast peoples behaviour but that's how i see it playing out at the moment.
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Clinhope
Posted on: May 7 2019, 07:10 PM


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I agree with what you’ve said, possible conspiracies and all. But in addition to what’s been said today about sunscreens i want to say that Scenesse will not be the end of sunscreens whatsoever.

Any person of any skin type that is on Scenesse will still need to apply sunscreen, from both health organization and personal perspectives. I can see Scenesse as being another layer of protection from sun damage and i believe that Clinuvels OTC products will have sunscreen qualities in them.

62 DAYS AND COUNTING!!!!
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Clinhope
Posted on: May 6 2019, 09:29 AM


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Approval after a second rejection seems unlikely even if it is only based on production facility processes and not clinical data. The fact they got a second rejection takes the risk into a whole new level.

https://www.raps.org/regulatory-focus™/ne...-approval-times
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Clinhope
Posted on: Apr 28 2019, 09:36 AM


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Hey guys,

I was going to write a reply last night but thought better of telling others what to do. This morning i can't hold back.

I think everyone here is in a relatively great financial position as the s.p currently stands. I realise wealth can be a fleeting, fickle thing, one stupid move and it will be gone in a flash. But i just want to illuminate the other side of the "every dollar i spend now is so much i won't have down the road".

The last 5 years has been the toughest i've ever faced, life just throwing one thing after another. It's taken people from me that i can never get back and will never have the chance do the things i dreamed of doing with them. I had the money, i thought i had time on my side too. But it turns out i didn't.

Don't make the same mistake. Hold two ideas in your mind, 1. don't waste money 2. don't waste time holding off on things that really mean something to you.

Cheers.

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Clinhope
Posted on: Apr 26 2019, 07:16 PM


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Posts: 1,070

Thanks for asking that. This is first hand evidence of how i thought the non-believers see Clinuvel. A high risk company, over-valued and little potential of an upside with so few people to treat. LMFAO.
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Clinhope
Posted on: Apr 19 2019, 04:09 PM


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This coming Monday and Thursday the ASX is closed.
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Clinhope
Posted on: Apr 17 2019, 12:06 PM


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@johnny, at the moment I’d have to sell some CLINUVEL shares to pay for it which really seems counterproductive.

@hamster, well said. Here and Uho on GG has all the bases covered.
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Clinhope
Posted on: Apr 17 2019, 09:45 AM


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I guess you applied for access and are waiting for a reply?
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Clinhope
Posted on: Apr 16 2019, 02:14 PM


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Yes we have yolo. It’s mostly an unknown and unlikely to be a threat to Clinuvel anytime soon.
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Clinhope
Posted on: Apr 14 2019, 10:28 AM


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I think some of the more knowledgable investors here have spoken about this before, but judging by the current price, where we are at the moment relative to some of the highest share prices in Aus then there will need to be a share split soon otherwise the s.p when fully fledged will dwarf even the largest companies.

Is that basically right?
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Clinhope
Posted on: Apr 11 2019, 12:21 PM


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So we should all write to him when the sp reaches double again shortly after July 8th.
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Clinhope
Posted on: Apr 11 2019, 08:35 AM


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Could be! That would be one cheeky "Easter Egg".
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Clinhope
Posted on: Apr 4 2019, 02:52 PM


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If i remember correctly it did quite well for AK and organ transplant recipients?
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Clinhope
Posted on: Mar 28 2019, 07:22 AM


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https://twitter.com/ClinuvelNews

"Each silicon atom is connected by 4 strong bonds, keeping electrons in place so current can't flow. A silicon #SolarCell uses 2 types of silicon that are either of negative (-) or positive (+) charge, the latter are also known as holes."

For all we know they could be updating the website to branch out into solar panels.
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Clinhope
Posted on: Mar 24 2019, 02:35 PM


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Yep i agree. I guess I’m just really concerned about the ramifications of the worldwide QE for the last 9 years and how inflated the derivatives, real estate and stock market is. Chances are I’m being overly paranoid when it comes to thinking the financial system will be turned upside down when the tsunami of debt comes crashing. Putting my paranoia aside things will be go south for a bit and then the fed will just alleviate the worlds debt addiction with QE to levels unprecedented even by todays standards.

Anyway! By 2020 we should still be right to get the Porsches and Mansions, and if you live in Australia maybe a tidy 3 bedroom house 30 minutes outside of the cbd.
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Clinhope
Posted on: Mar 23 2019, 01:37 PM


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Seemingly spanked just ahead of the rest of the US market. This is what worries me the most. That we get approval and then the next crisis comes steaming through.

Not to be an alarmist, Clinuvel looks to be a safeguard against whatever is coming. But we will need to be prepared for some hard hits. CUV, GOLD, CASH. .
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Clinhope
Posted on: Mar 21 2019, 04:57 PM


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Sometimes. If the mass of monkeys (mostly professional traders) out there inflate the PRICE well beyond the VALUE, or undervalue a stock from fear that's when I've made good returns, think VW diesel gate and possibly now with Boeing.

So the only reason i can imagine Clinuvel currently not being overvalued as a single drug biopharma ahead of FDA approval is that it, for whatever reason, hasn't caught the attention of the monkeys, they don't see the scope of potential. All they are seeing is "EPP-SMALL POPULATION-EXPENSIVE-POSSIBLY VITILIGO-NOT MUCH ROOM TO GROW" and i put that down to the understated tone CUV has put forward for the last 10 years or so.

It feels like we are the lucky few to see the truth, i hope that turns out to be true come July 8th.
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Clinhope
Posted on: Mar 21 2019, 04:17 PM


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That is the logic which underpins over 90% of the international stock markets. "Modern portfolio theory" is responsible for us having gone under the radar for the last 5 years or so and allows people like us to pick up once-in-a-lifetime stocks for what will hopefully turn out to be dirt cheap.
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Clinhope
Posted on: Mar 21 2019, 12:50 PM


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Don't worry i wasn't far off $29, buying in last week. And probably a few more to add to the pile next week.
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Clinhope
Posted on: Mar 20 2019, 11:33 AM


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It would be a lengthy process to reverse surely? I would've thought it would be a case of "tough titties" i.e bad luck!
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Clinhope
Posted on: Mar 2 2019, 07:56 AM


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I almost thought it said #psychedelics for a second. Which would've explained the post thoroughly.
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Clinhope
Posted on: Feb 16 2019, 01:41 PM


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"and meeting orphan disease needs I would say that it is riskier to not hold Clinuvel than it is to hold it. "

I agree, which is why it is the only stock i'm holding on to, despite my dire fears for what may come for international economies.

@seeva222, i had a look back at some biopharma stocks during the 2008 GFC , Allergan for example, but none seem to be an adequate comparison for CUV. Any ideas?
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Clinhope
Posted on: Feb 15 2019, 09:09 AM


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Hey guys,

I thought I’d raise a subject which I haven’t seen on this board before, one that I think will be one of the only obvious things to have any negative effect on the mid-term trajectory of the CUV sp and possibly (but hopefully not) the roll-out of the drug.

I raise this issue here out of respect and curiosity for the opinion and experience of the fellow CUV longs.

Strong speculation ahead!

Surely everyone here has heard of the possible looming economic crisis. The markets shook from October to December last year only to turn 180* over the last couple of months and recover much of what was lost. Clearly CUV/CLVLY are detached for various reasons from the wider market speculations and fluctuations. Yet there may be a storm on the horizon with the potential to land a few blows to our ship.

I’m no economic expert, yet to me, the current global economic systems that have risen since the GFC are the equivalent of real world Monopoly. With the Reserve Banks acting as the banker and everyone else as the pieces on the board. The vast majority of European countries have levels of debt they will never be able to pay off, the same goes for China, the US and Japan. The core functions are broken and the Fed continues to play puppet master attempting to continually stoke the markets flame by adjusting rates and taking on banks bonds-assets-debts.

As the U.S bond yield curve flattens and surely inverts, Italy implodes dragging the rest of Europe with it, and countries around the world continue with “Quantitative Easing” I will be shocked if the next global economic crisis doesn’t appear within the next two years.

It’s an unfortunate scenario, one I’m sure many think won’t happen. And some who think it’s people like me that bring it about. But my question to those here is, if or when it does happen, how do you think it might affect Clinuvel?

Personally I think we will see this the collapse happen in the second half of 2019. The markets and Feds may be able to bluff their way into a continuing Bull market for now, but not for long. The possible crisis would only blunt the Clinuvel s.p and possibly delay the current potential by a year or two. Approval will go ahead, but I could see trouble with insurers willing to fork out the money if the crisis is as bad as I think it will be.

I look forward to hearing others thoughts on this.
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Clinhope
Posted on: Feb 13 2019, 03:12 PM


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Nicely done Punk. My first guilty pleasure was a bit more subdued than yours for the time being (some high end audio gear) but the first big guilty pleasure will be POST APPROVAL haha. Can't take the leap just yet.
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Clinhope
Posted on: Feb 7 2019, 04:59 PM


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@waz, yep that should be an interesting week assuming we make the new listing.

No one is surprised by the closing price?! $23.45
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Clinhope
Posted on: Feb 7 2019, 03:11 PM


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So the ASX top listings are calculated on the third Friday of a given month after closing, the next specified month being March. Does that mean we can expect the new listing to be posted first thing monday morning on the 18th March?
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Clinhope
Posted on: Feb 2 2019, 01:35 PM


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Is there some way we can see your comment? I had a look but couldn't see where it is. I'm sure you'll keep us posted regardless.
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Clinhope
Posted on: Feb 2 2019, 11:40 AM


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I was just watching a Joe Rogan podcast with David Sinclair where they talked about various molecules and drugs being developed. At one point David talks about some molecule that treats psoriasis through anti-inflammatory actions. Joe asks if all immune disorders are inflammatory based to which David says he believes so. To which Joe says ohh, because i have vitiligo. He then proceeds to write down the name of this pre-clinical drug which has no actual evidence related to treating vitiligo in the hope it might do something.

Two things, how in the hell can a guy as worldly and information hungry as Joe not have heard of an effective vitiligo treatment on the cusp of approval?
And, how can we best get the message to him? Anyone here know how to actually use twitter?
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Clinhope
Posted on: Feb 1 2019, 10:43 AM


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With 7.4 millions views and counting the moderators of Sharecafe CUV forum have a strong interest in keeping the peace. No one needed to say anything.

Does anyone think this could effect us? https://www.statnews.com/2019/01/31/in-bold...n-drug-rebates/
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Clinhope
Posted on: Jan 30 2019, 03:32 PM


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Has anyone considered the micro needle patch as a delivery method? Would this be a tidy work-around for large molecule penetration?
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Clinhope
Posted on: Jan 25 2019, 02:22 PM


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Just for my reputation sake i did not mean to thank iggy for that post. It was meant for Johnnytechs post instead.
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Clinhope
Posted on: Jan 25 2019, 08:53 AM


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Two or three indications, 3+ years of top notch safety, tens of thousands getting treatment in the U.S and then it will be time to LOOK at allowing off-label for specific cases to expand the scope of treatment. Unless PW is looking to only ever allow treatment for approved indications even after he's gone, which would be unfathomable in the history of pharmaceuticals at this level.

What really annoys me about this discussion, and it's fine and expected for PW to establish a tight control over distribution and prescribing, but for us here on a FORUM to be that shit-scared that we can't discuss the expansion of treatment for things that aren't cosmetic is ridiculous. We have all seen the potential of this treatment for everything from AK, potent antioxidant, to acne. https://rosacea-support.org/scenesse-shows-...e-for-acne.html

A nice little write-up on Scenesse. https://www.dermnetnz.org/topics/afamelanotide/

Fellow Aussies have a good long wknd.
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Clinhope
Posted on: Jan 16 2019, 05:24 PM


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PW responds to our conversation on Twitter?

CEO, Dr Philippe Wolgen: ‘Controlled-use of novel technology is central in our thinking’.

Awesome, the wonders of technology.
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Clinhope
Posted on: Jan 16 2019, 09:32 AM


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Seems like a bit of an over-reaction to say that Scenesse shouldnt be used for a population that it may help without adverse affects after it has been approved. We know that when being used for any various indication it will likely be effective and definitely safe.
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Clinhope
Posted on: Jan 15 2019, 07:33 PM


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Can anyone speak confidently about the limitations of prescribing if we get approval. I’ve heard it mentioned before that FDA can limit/ban off label use but haven’t heard in what circumstances they make such a choice.

Surely limiting the off label usage when the potential benefit to help so many other patient indications with an extremely safe drug is unfounded in this case.
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Clinhope
Posted on: Jan 15 2019, 10:27 AM


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Sorry can you repeat that. I don’t understand what you mean. biggrin.gif
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Clinhope
Posted on: Jan 15 2019, 10:27 AM


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Sorry can you repeat that. I don’t understand what you mean. biggrin.gif
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Clinhope
Posted on: Jan 12 2019, 07:13 PM


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Hey Iggy, i hope you had a good Christmas and New year! I'm pretty sure majority of the people here have not only taken tax into account for when they do sell some shares, but most will likely make enough money post tax that there will be a divorce fighting over the money and how to best spend it instead of the tax bill.

Funnily enough i'm doing my tax now for 17-18 and found out that more than half of my Clinuvel shares were bought at 18cents. That sure is bitter sweet.
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Clinhope
Posted on: Jan 12 2019, 06:42 PM


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Up till last week i would've said Celgene was a strong buy certain of making a decent return. Yet a takeover deal has sprung up, yes also causing CELG to shoot up 30% in a week but has also as far as i can tell put a leash on CELG's future prospects as a respectable Biopharma.

Apart from that i would hold off on the re-investing, the 2000 trillion $ global debt (yes that is 2 QUADRILLION DOLLARS) tells me a storm is brewing on the horizon. Clinuvel should be a safe harbour for some of your money.
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Clinhope
Posted on: Jan 12 2019, 02:17 PM


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I've tried to share the potential of this company with everyone from close family and friends to my accountant and even a podcast that covers Biotech every Wednesday. I've even written longgggg emails to friends to try and describe the past present and possible future to no avail. The light just doesn't turn on for them. For all of us i think the light turned on pretty quick.

They either couldn't see the potential or couldn't see that what had been achieved to that point was only the beginning of much bigger things to come.

Friend:"What did you buy in at?"

Me: "$3".

Friend:"Where is it now?"

Me:"$18"

Friend:"Ohh well that's good for you"

Me:"..... stun.gif "

Of course well done to everyone who's held on through the silence and missed targets. I just hope that when the rubber hits the road in the second half of 2019 that the road is already paved well ahead to get Scenesse to the people in need, ASAP.
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Clinhope
Posted on: Jan 9 2019, 09:03 AM


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Seems like a huge benefit to Clinuvels plight. Can we foreward that to NICE and the Norway agency?
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Clinhope
Posted on: Jan 8 2019, 07:08 AM


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Theyve clearly taken a leaf out of NICES book and used the same rhetoric to reduce costs to the national scheme.
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Clinhope
Posted on: Jan 3 2019, 06:51 AM


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A new scientific communique. I find it interesting that over 90% of the communique is about stuff other than Afamelanotide and that 90% sets up a vague summary of what potential Afamelanotide (not Scenesse for whatever reason) might have. Don't get me wrong, it is informative about the disease and current treatments which i appreciate. But who are these communiques written for....


The 10%
Afamelanotide: an analogue of α-MSH designed to assist in vitiligo repigmentation


Significant advances in the understanding of the factors which influence melanocytes and their stem cells have lead to improved clinical care for patients with vitiligo. The potential of α-MSH and its analogues to further stimulate these developing melanocytes following ultraviolet therapy, to aid in repigmentation of the vitiliginous skin, is an exciting prospect.

Patient responses to NB-UVB are hugely variable. It is impossible to predict whether vitiligo will improve as a result of the treatment, and if so, to what extent. Considerable time and resources are required to reach a clinical conclusion as to whether NB-UVB therapy is effective and there are potential long term risks associated with repeated exposure to UV radiation, a known carcinogen. Thus, there is a clear argument for the exploration of potential combination therapies with NB-UVB which could reduce the number of clinical visits required to achieve repigmentation.

Based on knowledge of the processes involved in repigmenting vitiliginous skin with NB-UVB, there are clear scientific grounds for the combined use of this light therapy with α-MSH analogues. Afamelanotide, the most clinically advanced α-MSH analogue, is thus a natural therapeutic candidate. It has a greater binding affinity with the MC1R on melanocytes than natural α-MSH and is therefore able to more readily activate melanin to repigment skin. It is hoped that treatment with afamelanotide, in conjunction with NB-UVB therapy, will produce faster, more consistent repigmentation of vitiliginous skin.
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Clinhope
Posted on: Dec 27 2018, 12:33 PM


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Pediatric formula.
Australia and Japan “TGA” applications.

Both seem important enough to be on your list biggrin.gif

Merry Christmas and Happy New year to you all. 2019 will be the start of a new era.
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Clinhope
Posted on: Dec 23 2018, 09:10 PM


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I don’t speak german/dutch, whichever that was. Was it more of the typical coverage or something unique?
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Clinhope
Posted on: Dec 19 2018, 10:50 AM


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Did you guys know the vitiligo results are out?!!’ 😆

Thank goodness for that. The results seem good all round. 21 people in the study, 3 withdrew for negative cultural associations with skin darkening, worked everywhere but the feet, pigmentation maintained for 3 months after treatment.

Would have appreciated a couple of photos though.
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Clinhope
Posted on: Dec 18 2018, 11:53 AM


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As it stands it looks like PW won’t be getting an early Christmas present. So assuming PDUFA is announced 1st qtr 2019, we’d still be looking at FDA decision before 2020, right?
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Clinhope
Posted on: Dec 10 2018, 03:08 PM


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Quite often you’ll see the price post approval shoot up due to hype and then drop once the first few qtrs results come in.

Although I don’t think that will be the case here. Unless there are unforseen snags in regards to regulations, insurances, clinics etc the hype and sales will push the price up and up post approval once the cat is out of the bag.
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Clinhope
Posted on: Dec 6 2018, 06:30 AM


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Quite an informative presentation on the inspection process.

https://www.fda.gov/downloads/drugs/develop...e/ucm466481.pdf
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Clinhope
Posted on: Nov 30 2018, 04:02 PM


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You don't watch the closing trades that often do you? biggrin.gif

Just in relation to the FDA inspection of the production facility/ies i don't think i view it with the same pessimism as other here.

I don't know the history of these inspections, but to me it is a sign that the FDA is in the final stages of assessing the application and this would be one of the last hurdles for them to undergo.

I think we are still on track for PDUFA early 2019 and approval mid 2019. I don't see why this inspection would delay things.
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Clinhope
Posted on: Nov 24 2018, 06:58 AM


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Speculated by us and logical but I’ve never seen it specified by Clinuvel as transdermal or self administered.

But you’re probably right, it would’ve been there since the new site went up i just never noticed.
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Clinhope
Posted on: Nov 23 2018, 06:41 PM


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FDA GMP inspection pg 12 of the AGM slideshow.

Also, i was just browsing the Clinuvel site and read something i haven't seen specified or maybe i just remember:

"VLRX001 is an addition to the family of melanocortin analogues which provoke increased and prolonged cellular activity. It contains a specific peptide sequence, designed to make it less susceptible to degradation than physiologic (natural) alpha-melanocyte stimulating hormone (α-MSH).

The VLRX001 development work was undertaken through CLINUVEL’s Singaporean subsidiary, VALLAURIX and has leveraged the knowledge gained from long term experience with the clinical use of SCENESSE®. Formulation work will focus on the development of VLRX001 for topical self-administration by patients. The transdermal product will initially be evaluated as adjuvant maintenance therapy in the depigmentation disorder vitiligo."

I can remember discussion here about the two new products potentially being topical a-MSH's, as the regular peptide molecule is too large (?) to be readily absorbed, they would need a smaller peptide but no one had come up with a solution.

So did you all know about this?!
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Clinhope
Posted on: Nov 21 2018, 02:15 PM


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None! No more crumbs. What a surprise grrr.gif
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Clinhope
Posted on: Nov 21 2018, 12:47 PM


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I'm just going through the presentation now and noticed something a little interesting. Did anyone notice the two small pictures of a spray and a cream on page 26 in relation to "world's first locoregional photoprotection"?

They could just be pictures for the sake of putting something there, or they could be showing that the 2 forthcoming products cuv9900 and vlrx001, one is a spray and one is a cream.

What other crumbs can we find.
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Clinhope
Posted on: Nov 21 2018, 06:27 AM


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Iggy, im a bit shocked at your post...

Anyway here’s an excerpt that seems timely after yesterday:

“DNA damage, in the form of thymine dimer formation, was also shown to be reduced by 59% (P < .0033) in the basal layer of the epidermis of this group of subjects. This study has shown for the first time the potential ability of a synthetic hormone that augments melanin production to provide photoprotection to people who normally burn in direct sunlight.”
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Clinhope
Posted on: Nov 20 2018, 06:10 PM


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Finally I’m all-in at a decent average. Sellers were teasing me, holding at $17.6 all of yesterday when my bid was 17.5 only to have it drop to $16.78 today.

I didn’t mean to summon the demon about the instagram comment.

Scenesse is safe, the tanning from Scenesse does not cause DNA damage and in fact it probably reverses or minimises it.

Again, i think it silly that Clinuvel has started a public record of them stating the flawed idea “there is no such thing as a safe tan” that will clearly be in direct conflict to the message they will be spruking post approval and can be quoted by anyone with an agenda against them.
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Clinhope
Posted on: Nov 20 2018, 06:44 AM


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Yeh i did know that. My point was it seems completely stupid for Clinuvel to say tanning=Skin damage, yet made no effort to say why the tan Scenesse brings on is different.
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Clinhope
Posted on: Nov 19 2018, 09:41 PM


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Right, thats a relief then. Didn’t expect royco to be quite so pessimistic.
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Clinhope
Posted on: Nov 19 2018, 06:48 PM


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So you attended the AGM royco? Haha if that’s what they didn’t talk about, them what in the hell DID they actually talk about?

Meanwhile, Clinuvel reminds everyone that “tanning is a response to skin damage from UV radiation”. UMMMM....sooooo When Scenesse tanns the skin it’s doing what exactly?

I feel sick.
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Clinhope
Posted on: Nov 17 2018, 07:20 AM


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He’s referring to FDA approval in early 2019, or his commemt could be taken to say at its worst that anytime before christmas 2019 which we all know is well within FDAs guidelines for approval.

As the interviewer says “fda approval in early FY19 is what we’re hearing”.

And then PW says: “well we hope we’ll have an early Christmas present of 2019”.
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Clinhope
Posted on: Nov 15 2018, 08:32 PM


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After blackm3’s possibly most liked post ever on SS, here is the link to the yourmoney video only posted today.

https://www.google.com.au/amp/s/www.yourmon...rading-day/amp/
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Clinhope
Posted on: Nov 13 2018, 09:18 AM


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This instagram post actually annoyed me a little:
https://www.instagram.com/p/BqFja1Fns63/?ut...d=1hcefkosn5yz5

How about instead of educating us about “how clinical trials work” you educate us on how YOUR clinical trials worked or otherwise!
I guess to be fair, i think it’s likely the reason they haven’t spoken about the Singapore vitiligo trial is because they are waiting for the FDA NDA decision. When they said trial results would be forthcoming they didn’t expect the delay we are currently in.
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Clinhope
Posted on: Oct 30 2018, 09:25 AM


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@macgyver: I have to say that’s the way I’ve seen this stock trade for the last 5 years or so. Clearly manipulated to a price someone deems necessary and the small number of real investors and traders play along none the wiser and mostly powerless.
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Clinhope
Posted on: Oct 21 2018, 03:44 PM


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Dont think ive was Ive seen this posted before:

http://www.porphyriafoundation.com/sites/d...d%20implant.pdf
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Clinhope
Posted on: Oct 17 2018, 08:39 AM


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Interesting.

https://www.instagram.com/p/Bo_x7vQDyXU/?ut...id=qlqw4smmkx5m
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Clinhope
Posted on: Oct 13 2018, 07:17 AM


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https://social.eyeforpharma.com/patients-an...changed-my-life

Just another person with EPP whose life has been positively transformed by Scenesse. Nothing to see, move along.

Rocco also appeared on tv recently talking about his story.
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Clinhope
Posted on: Oct 10 2018, 10:04 AM


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18th Annual Biotech in Europe Forum.

https://yourir.info/resources/fee77b1d1a878...urope_Forum.pdf

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Clinhope
Posted on: Oct 8 2018, 09:59 AM


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Fantastic idea investek, i gave my details a bit late but when i recieve it ill make a donation.
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Clinhope
Posted on: Oct 5 2018, 10:29 AM


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Hey Punk, have you seen anything about the followup of people with vitiligo? Say the treatment is a success where does their condition stand 12 months down the road?

Would be interesting to know something about how long the improvement lasts.
  Forum: By Share Code

Clinhope
Posted on: Oct 4 2018, 09:41 AM


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Punk can probably soeak ti this with authority, but the lighter parts of the skin should darken at a much faster rate than the normal parts of skin.
  Forum: By Share Code

Clinhope
Posted on: Oct 3 2018, 08:45 AM


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Don’t apologize for such great information integral to helping form a picture of the hidden world of Clinuvel.

A very interesting post.
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Clinhope
Posted on: Sep 30 2018, 02:06 PM


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Also being used for treating vitiligo. I stumbled across this while looking into recell. http://3af4pk1d7ktnf8ieb2pl91t1.wpengine.n...es-in-China.pdf
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Clinhope
Posted on: Sep 27 2018, 05:53 PM


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Posts: 1,070

Motley fool has some great podcasts, one in particular being "Industry Focus" that often talks about the latest Biotech stocks doing something cool. I would've contacted them already to suggest they look into Clinuvel if i wasn't selfish and didn't want to keep this all to myself up to FDA decision.

The fact that the broader market has taken this long to catch on and there are still people who look at Clinuvel and are hesitant about its future boggles my mind. Am i missing something or are they?

$70 for a takeover. This is a once in a lifetime opportunity. We could easily see $70+ before 2020 arrives.
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Clinhope
Posted on: Sep 27 2018, 03:36 PM


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A bit more coverage in a Motley fool article, though he says he wouldn’t buy now, but will keep an eye on it :

https://au.finance.yahoo.com/news/too-buy-m...-015430294.html
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Clinhope
Posted on: Sep 26 2018, 10:10 AM


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I’ve been a bit distracted by other things for the last few months amd in the tsunami of info about Clinuvel haven’t kept up to date as i have for the last decade.

Can someone clarify that Clinuvel only stated there would be two new indications without saying what they are? So they could be vitiligo and XP but we’re not sure?
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Clinhope
Posted on: Sep 25 2018, 04:41 PM


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I think there are two ways to look at our current sp.

One is to say yeh it’s a true indication of the core value of Clinvel we’ve all known about for years. Only now the hoard is aware as well.

The other way to look at it is that nothing definite has happened to take us from $12 to $21 in less than a month amd we are like Seligmans dogs cowerinng in a corner waiting to be shocked yet again.

Anyway it is a true win/win scenario whether it goes up or down from here.
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Clinhope
Posted on: Sep 25 2018, 03:37 PM


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Does anyone think we will retrace back down again to sub $18? This growth seems artificial after such a long wait.

And to state the obvious i wouldn’t mind it going back down to pick up a few more as ive said many times before.
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Clinhope
Posted on: Sep 21 2018, 10:27 AM


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Yeh I’ve been watching it go from 50 sigs a day to one and then none. I find it perplexing that the epp community isn’t able to gain more interest from the general puplic and friends. I’m not judging them harshly, I don’t have a clue what the reality is over in the uk. But if it were me i would take my ipad down to local school and businesses, family, friends and ask if they can sign a petition for an amazingly positive cause.

Heartbreaking.
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Clinhope
Posted on: Aug 29 2018, 05:44 PM


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I get the feeling i've lost my chance to buy a few more at a good price. Having said that if the manipulators stay their course i still might have a chance :D
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Clinhope
Posted on: Aug 17 2018, 09:57 PM


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They will easily reach 10000 by feb 2019.
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Clinhope
Posted on: Aug 17 2018, 08:31 AM


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There seems to be quite a few people here interested in Palatins Bremelanotide. As an investment opportunity surely you’d be looking at AMAG instead of PTN as AMAG will take exclusive rights of the drug and PTN only recieving royalties...
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Clinhope
Posted on: Aug 6 2018, 06:49 PM


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Because Iggy this is the only drug that fucken works well and doesnt have disastrous side effects. (Unnecessary swearing is a side effect of being from Australia.😆)
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Clinhope
Posted on: Aug 4 2018, 06:25 PM


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Did he say what his firm is waiting on before they buy in?
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Clinhope
Posted on: Aug 4 2018, 12:45 PM


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Mrdax, "In the whole document I don't find the non-approvd drugs; especially because I was also searching the total number of drug filings in 2017 earlier, to calculate the approval rate."

So you're saying that there might've been 200 novel drugs for eg that were up for approval but only 46 were granted. The pdf then goes on to detail the approval rates of those 46 and ignore the rejected novel drugs. In which case of course they'd all be approved and i see your point. But wording like this suggests to me that there were only 46 novel drugs and all of them were approved. Pg 14 "In 2017, CDER met its PDUFA goal dates for 100% of the novel drugs approved (46 of 46)."

Then the only really relevant part is to focus on 46 of the 35 novel drugs were approved (85%) in the first cycle. Leaving 11 novel drugs which had insufficient submissions, missing information etc but were able to still achieve approval on the second cycle as we know all 46 were approved. Right? wacko.gif

Whatever the details the stats are good for what title in the review process Scenesse has currently gained. Priority review will be the next title im sure.

I like the graph that shows the novel drugs with one or more expedited pathways had the highest chance of getting approval/equal with priority review @ 61% (yes i know 100% gained approval ):
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Clinhope
Posted on: Aug 3 2018, 09:51 AM


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Hahaha it does too. I'll be going there in a few months i'll keep an eye out for approved FDA towns.

Facebook thought it appropriate to place a safe tanning pill advert on my feed and i had to share it: https://dr-viton.com/product/dr-viton-bronzan/

The comments on FB (e.g "ohh wow i can't wait to take one pill and get tanned for summer!!!!!!!!!!" biggrin.gif biggrin.gif biggrin.gif )and the list of active ingredients makes me feel sick.
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Clinhope
Posted on: Aug 3 2018, 09:21 AM


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Posts: 1,070

Just to reiterate (because i hate when people post vague information here), the companies (from seeva22) in 2017 which had fast track were all approved, no rejections:

1. Aliqopa - Approved -
2. Bavencio - Approved -
3. Baxdela - Approved -
4. Bevyxxa - Approved -
5. Emflaza - Approved -
6. Idhifa - Approved -
7. Ingrezza - Approved -
8. Mavyret - Approved -
9. Mepsevii - Approved -
10. Ocrevus - Approved -
11. Prevymis - Approved -
12. Rydapt - Approved -
13. Solosec - Approved -
14. Vabomere - Approved -
15. Verzenio - Approved -
16. Vosevi- Approved -
17. Xermelo - Approved -
18. Zejula - Approved -

Pretty good record i'd say.
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Clinhope
Posted on: Aug 2 2018, 10:12 PM


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In 2017 all were approved that had fast track status.

See previous discussion: http://www.sharescene.com/index.php?showtopic=27&st=610

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Clinhope
Posted on: Aug 1 2018, 09:25 AM


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Just out of interest how far do you think $30 is from its 10 yr potential, say ~2028? See my guesstimate is that a year or two after approval we’ll be close to if not past 30. At which point I’d be better of selling small parcels as needed than sell prematurely with a takeover.
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Clinhope
Posted on: Jul 22 2018, 07:49 AM


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I was just watching a youtube channel called Veritasium and it uncovered for me, why it is that melanin and therefore Scenesse is so effective for various purposes. I always thought the melanin was simply a super effective UV shield, but apparently the melanin actually forms a protective cap around the nucleus of each cell. I guess the more melanin the more complete and robust the protective cap around more of the cells nucleus'.

Watch for about 30s to see the relevant part: https://youtu.be/V9K6gjR07Po?t=5m15s
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Clinhope
Posted on: Jul 19 2018, 08:42 PM


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Possibly an attempt to drop the price as much as possible before FDA priority review decision and limit the following run upward?
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Clinhope
Posted on: Jul 19 2018, 11:31 AM


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What gives you that idea?
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Clinhope
Posted on: Jul 2 2018, 05:15 PM


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Can anyone think of a reason why that large trade wouldn’t show up on my commsec sales?
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Clinhope
Posted on: Jun 22 2018, 06:06 AM


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Does anyone understand why someone would apparently go through the trouble of spending millions developing a drug for an indication already taken in Europe and likely to soon be taken in the US?

It seems too risky to me, the chance of the drug working is low in general, it takes at least a decade to develop (30 in clinuvels case), costs a lot, and in this case you have a proven and approved competitor.

Anyone have a decent reason?
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Clinhope
Posted on: Jun 14 2018, 04:42 PM


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Known to cause serious side effects?! What a blatant lie. Even the illegal MT1 isn't associated with serious side effects, nor is the MT2 which is much more potent and has considerably harsher sides (darkened moles, increased libido, hyper pigmentation for eg). What fool wrote that article?

And i struggle to imagine anyone would be silly enough to risk the tens of millions of dollars taking a new drug through clinical trials when Clinuvel is likely to beat them to the finish line by at least 5 years considering the current pace.
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