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Dr Wally
Posted on: Yesterday, 01:41 PM


Group: Member
Posts: 344

Cheers for that information much appreciated. I still have much to learn here. 🤓

I was MIA when all that came to light: I must have taken a break from it all for a few months and completely missed it all. The glacial progress of Clinuvel has gotten to me a few time since getting involved in 2010 If truth be told. 🤬
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Dr Wally
Posted on: May 20 2019, 10:52 AM


Group: Member
Posts: 344

What sense would it make to apply a peptide hormone (afamelanotide) to the skin unless it’s ultimate purpose was to make its way through the skin, entering the bloodstream and having a systemic effect providing complete photo protection just as powerful as the implant IF dosage compliant. Multiple applications (dosages) per day the same way they first used the drug sub cutaneously.
EPP patients could attain the exact same protection via this route BUT it wouldn’t be worth the risk of getting the dosage wrong. Implant is the 100% safe option to take for these guys and the topically applied (systemic in action) cream will allow Afamelanotide to be taken up by the masses with minimal effort and much lower cost.

Suncreams are primitive (topical) and incredibly ineffective. Cover an area of skin with a chemical compound for sketchy protection: what about the rest of the body??

The days of hit and miss ineffective (alleged) sun protection are just about over. Safe systemic photo protection is the only logical option and will be a massive hit and see skin cancer rates fall like never before.

When Clinuvel mention topical in reference to Afamelanotide surely their intention is in the way the drug is applied no??

Topical vs systemic
By this definition, topical administration also includes transdermal application, where the substance is administered onto the skin but is absorbed into the body to attain systemic distribution. Such medications are generally hydrophobic chemicals, such as steroid hormones.


https://www.google.com.au/search?client=saf...160.9bBkO84kLIk
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Dr Wally
Posted on: May 19 2019, 11:56 PM


Group: Member
Posts: 344

True Royco but as you well and truely know, Clinuvels potential is absolutely phenomenal.
Who knows how big the little Australian company with the safe and beneficial photo protective drug will end up being. Simply going off of what we know right now, which is nowhere near the full picture, is exciting enough and it’s obvious that there’s going to be a few more big surprises unveiled after approval to create even more excitement and value.
One more nod to see it all come to fruition.
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Dr Wally
Posted on: May 16 2019, 02:22 PM


Group: Member
Posts: 344


Ascending triangle ay. Well you know what that means Xray?

Takeover is imminent!! 🤓
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Dr Wally
Posted on: May 16 2019, 12:35 PM


Group: Member
Posts: 344

Soon as we reached (literally) 29.999 last time it triggered a large fall in the SP if I remember correctly.

FDA approval is the only thing that will end the uncertainty that surrounds this great company and bring an end to this stupidity yes?
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Dr Wally
Posted on: May 14 2019, 02:28 PM


Group: Member
Posts: 344



“Fair value”

It’s a reasonable evaluation on EPP alone and obviously that’s all most people are factoring in atm- but if you possess even the slightest amount of knowledge you’ll understand that if only half of the potential here is realised, $30 for a stake in this wholesome well managed company, will be seen (in the not too distant future) more accurately as an incredibly underpriced (because of a huge amount of uncertainty that continues to exist surrounding regulators) bargain..
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Dr Wally
Posted on: May 9 2019, 03:29 PM


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Posts: 344


I see millions of dead people! 💀💀💀💀

That’ll be future if the FDA reject Scenesse. This “Skin cancer epidemic” will become a skin cancer tsunami without effective photo protection in times of global warming. 🥵
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Dr Wally
Posted on: May 9 2019, 12:40 PM


Group: Member
Posts: 344

“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.”


2-3 years after EPP approval would be a fair, acceptable, realistic timeframe to allow the masses to benefit from the ultimate photo protection.

From my personal experience (since 2005) I can guarantee one thing: many minds will be blown when they eventually get to experience the extraordinary UVR blocking power that these special peptides bring about in the skin.

To continue to deny the use of this safe natural cancer preventative for another decade would be stupidity absolutely defined.
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Dr Wally
Posted on: May 7 2019, 11:06 PM


Group: Member
Posts: 344



I honestly can’t think of 1 excuse for keeping it out of reach of the masses. Anyone?

Super safe drug with the potential to flip the skin cancer epidemic on its head. There’s a couple billion dollar companies out there that might take issue with it I guess. 🖕🏾

GAMECHANGER! 🤓
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Dr Wally
Posted on: May 7 2019, 10:12 PM


Group: Member
Posts: 344


4 sure😎👍🏽🤑🤓🤘🏾
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Dr Wally
Posted on: May 7 2019, 09:56 PM


Group: Member
Posts: 344

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.

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?


This short piece is from a paper published in 2006 briefly hinting at the extraordinary photo protective properties of EUMelanin.

“Steady‐state fluorescence (emission and excitation)

It is not unusual to read or hear the phrase ‘eumelanin does not fluoresce’. This is untrue. Many studies have shown that synthetic and natural eumelanin do emit radiatively when appropriately stimulated by UV and visible radiation (Gallas and Eisner, 1987; Kozikowski et al., 1984; Mosca et al., 1999).

*****However, eumelanin possesses an extremely low radiative quantum yield, i.e. the ratio of emitted photons to exciting photons is extremely small.*****

Fluorescence yields of <7 × 10−4for UV excitation of synthetic eumelanin have been recently reported (Meredith and Riesz, 2004).

*****This means that more than 99.9% of all absorbed photons are subject to non‐radiative dissipation, a very useful property for a photoprotectant.*****Similar low yields for melanin fluorescence have also been reported by other researchers (Gallas and Eisner, 1987; Nofsinger et al., 2001).
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Dr Wally
Posted on: May 7 2019, 06:54 PM


Group: Member
Posts: 344

For what it’s worth I have 1000% belief approval is just around the corner: Scenesse (Afamelanotide) safety and therapeutic value simply cannot logically be denied for much longer.

I’m just pissed I guess because I put off buying a house in 2010 to buy into Clinuvel with it’s gamechanging drug thinking 3-5 years max and I’d be kicking back living the dream but NOPE I failed to realise how much resistance and ignorance to the truth within certain circles still existed. F@rk1ng ignorant k@ntsss🤬🤬🤬

Now I’m not going to go out on a tin foil encased branch to insinuate that the hundreds of millions of dollars “donated” by billion dollar suncream companies over the years to certain agencies for their “stamp of approval” had anything do with the glacial progress of this great drug but stranger thing have happened over the years havnt they!!😑👽👾😑 or have they??🎃

Anywayz, decent volume with SP on the rise after a “negative” possible further delays indicating?? communique is par for the course with Clinuvel. I’ll miss this insanity one day I’m sure. 🤓
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Dr Wally
Posted on: May 7 2019, 05:31 PM


Group: Member
Posts: 344

No I’ve never heard of it. Guantanamo bay on the other hand rings a bell. 👍🏽

Q1 for you: have you ever heard of hydration?

Q2 what about "solar-phobes"?

“Dr. Robert S. Stern, chair of the Department of Dermatology at Harvard-affiliated Beth Israel Deaconess Medical Center , calls them "solar-phobes": people so concerned about getting skin cancer that they stay inside or cover every bit of skin. "They cover up like they were going out into the Arabian Desert ," he says. The marketing of ultrablocking sunscreens and special sun-protective clothing plays into these fears.”


“The same DNA-damaging, sunburn-causing UVB wavelengths that sunscreens are designed to block also do some good: They kick off the chemical and metabolic chain reaction that produces vitamin D. Research shows that many people have low vitamin D levels. There is a well-documented relationship between low vitamin D levels and poor bone health. Now links have been made to everything from multiple sclerosis to prostate cancer. "Linking" low vitamin D with these diseases doesn't prove cause-and-effect, but it suggests that possibility. Getting some sun may also shake off the wintertime blues: Research suggests that light hitting your skin, not just your eyes, helps reverse seasonal affective disorder (SAD). Moreover, being outside gets us golfing, gardening, and engaging in other types of physical activity.”

Point - “solar phobes” with their unbalanced ignorance and unbreakable faith in and absolute support of sloppy chemical concoctions have kept the only drug that will ever be able to turn around this “epidemic” of skin cancer out of reach and out of sight. And for what have achieved by doing so?
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Dr Wally
Posted on: May 7 2019, 02:20 PM


Group: Member
Posts: 344

These partially effective but possibly toxic suncreams that make billions/year and have the unwavering backing of FDA and their cousins around the world have been suspected of being behind many “bad” things for many many years now. There’s a long long long list.

They’ve gotten a free ride for many many years because of the unbalanced outdated rhetoric feeding into the hysteria surrounding sunlight and skin.


A super safe and effective natural photo protective that doesn’t wash off or potentially create a number of disastrous health issues; one that 95% of people would actually want to use, would have to be seen as a game changing technology; one that might possibly destroy their old school chemical based product and basic outdated business model. I bet their hoping something brilliant like that never comes along.😎


“While science continues to answer questions about sunscreen, Califf and other experts call for the public to continue to protect their skin from the dangerous rays of the sun.”

Example of what I mean when I say “outdated” “unbalanced” rhetoric.

It’s just like stating that water is dangerous. 😐
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Dr Wally
Posted on: May 1 2019, 12:46 AM


Group: Member
Posts: 344

Thanks for the informative advice bud. 😑 Why would I hit submit more than once. Notice I hit the keys on the keyboard once when I type words. I get the concept. 😉
Faster connection? NBN fibre to the modem my friend 100/40Mbps connection.

Didn’t post twice this time. Woohoo! You might be onto something hey.😎

Just for fun I tried to hit “submit “ multiple times. Nooooope. 🤓
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Dr Wally
Posted on: May 1 2019, 12:28 AM


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Posts: 344


D'oh! Double post again! Why?🤬🤬
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Dr Wally
Posted on: May 1 2019, 12:28 AM


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Posts: 344

“Should you invest?

Whilst I think CLINUVEL is an exciting company and SCENESSE is a quality product, I wouldn’t be a buyer of its shares at the current level for valuation reasons.

As strong as its growth has been this year, I’m not convinced it justifies its market capitalisation of approximately $1.15 billion.

One ASX Stock For An Estimated $US22 Billion Marijuana Market

A little-known ASX company just unlocked what some experts think could be the key to profiting off the coming marijuana boom.

And make no mistake – it is coming. To the tune of an estimated $US22 billion.”


******** Uummmm hello! CLINUVEL has the KEY to profiting off of the coming photo protection boom. Clinical research has also shown the drug to be of benefit in a number of important areas of human health that could turn out to be just as remarkable and lucrative.

Make no mistake, this wholesome Australian company hasn’t even started it’s growth phase yet and these figures will be dwarfed within a few years of the all important FDA approval being attained. Underestimate the sleeping giant Clinuvel at your own peril. ********
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Dr Wally
Posted on: Apr 30 2019, 09:36 PM


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Posts: 344


Nice detective work Sherlock, I mean mcgyver. 🤓

The signs couldn’t be any more positive could they. If I had EPP and lived in the states I’d be pretty freakin excited. I new lease on life is surely just a few months away. 😎


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Dr Wally
Posted on: Apr 28 2019, 11:47 PM


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Posts: 344


ironically might make more sense 🤓
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Dr Wally
Posted on: Apr 28 2019, 11:47 PM


Group: Member
Posts: 344


ironically might make more sense 🤓
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Dr Wally
Posted on: Apr 28 2019, 07:52 PM


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Posts: 344

It p1sses me off when I think about the years that have been wasted frustratingly because of the very thing that lies at the heart of this cancer preventative drugs certain success: EUMelanin. Aka a photo protective “tan”.
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Dr Wally
Posted on: Apr 27 2019, 08:38 PM


Group: Member
Posts: 344


“with three chunks having been cut from my face already and more sure to come I’d be getting my hands on this quick as a flash if I only could.”

What’s stopping you? God only knows how many more years it’s going to take before the general public will be officially allowed to access these safe photo protective drugs.
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Dr Wally
Posted on: Apr 26 2019, 09:46 PM


Group: Member
Posts: 344


The vast majority of people only see a cosmetic side to photo protection, that obviously being a “tan” and mistakenly believe it to be superficial with no idea of the incredibly vital role EUMelanin plays. Most scoff and ignorantly believe that anyone wanting to have a darker, extremely protective skin tone as simply being vain. Funny thing is if tanned skin isn’t attractive to you then this alleged cosmetic side doesn’t even exist.

You either see the outrageous potential of a completely safe, 100% natural (EUMelanin) skin cancer preventing photo protectant with therapeutic qualities or you don’t I guess.

The melanocortin enlightenment is fast approaching. 😉
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Dr Wally
Posted on: Apr 18 2019, 02:55 PM


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Posts: 344

There have been many times when I’ve deluded myself for sure but not with this baby. Safety is always a legitimate concern until proven otherwise. In the case of Scenesse its been well and truely proven scientifically and anecdotally via 15 years of grey market use and possible abuse. How long is long enough to have safety concerns stifle a *brilliant* drugs progress?

Seeva has put sh1t on my posts many times before so that’s why I was a little harsh. I didn’t expect anyone else to take offence, especially concerning Scenesse safety.😬
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Dr Wally
Posted on: Apr 18 2019, 02:04 PM


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Posts: 344

“As long as the safety profile holds up”

Haha are you serious? Safety hasn’t been an issue for a long, long, long time. Scenesse is better than safe it’s actually therapeutic so there’s no sane reason to cause concern or even question safety in 2019.

On the other hand FDA rejection for a second time would devastate this company BUT theres no logicall reason at all for that to happen: is there?😬. It would be an injustice based purely on stupidity and complete ignorance if it were to happen. Not happening!

In 2019 the FDA explicitly understand the incredible health benefits of this drug even though it will open the door to mass Afamelanotide usage down the road but what would be the problem with mass use of a super safe drug to prevent devastating diseases anyway? Were not in 2005 anymore Toto!

Expect plenty of SP games till FDAs fortifying, validating, uncertainty destroying approval is announced.

The lower the price goes the stronger the buy. These opportunities will be long gone soon so if the market is stupid enough to let the bottom fall out of Clinuvels SP before FDA approval then that’s a great thing.

Oh sh1t, now I see. That’s what your doing questioning the safety. Haha nice one. 😉

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Dr Wally
Posted on: Apr 17 2019, 03:05 PM


Group: Member
Posts: 344


Good luck taking on the bots. Maybe you can spend a few $$ and become one of them?🤖 Uncertain markets are their playground.

https://www.thebalance.com/automated-day-tr...are-eas-4142824
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Dr Wally
Posted on: Apr 2 2019, 11:03 PM


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Posts: 344

Anyone desperate enough to use fake ass tanning lotions would kill for a real 100% natural photo protective tan I’d imagine. 👍🏽

Haha! What I see from the past that leads me to believe a smooth ride from here on in is a very real possibility is the fact that the FDA have had in front of them for some time now a virtual library of nothing but positive data concerning Scenesse. Approximately 2 decades worth. ✌🏾
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Dr Wally
Posted on: Apr 2 2019, 10:42 PM


Group: Member
Posts: 344

Any predictions?

Seeings your asking Royco 🤓 Im predicting there’ll be no more excruciating delays with PDUFA then a tonne of interest, love and support thereafter.
It should be smooth and possibly slightly quicker than expected simply because in 2019 FDA fears or uncontrolled mass usage of the drug have been replaced with the understanding that the implant will be cost prohibitive, scrutinised and so tightly managed that it would be virtually impossible to obtain without solid proof of a light sensitive disease, and a long suffering US EPP community would be extremely grateful to have access this summer to the safe drug that will completely transform their lives.

Also it wouldnt be unreasonable to believe that the FDA have completely accepted the science by now, seen and accepted the mountains of more than positive data on safety, data that ctually shows therapeutic value, efficacy that allows a person with acute photosensitivity (EPP, XP) to spend hours bathing in strong summer sunlight. Add to this a newfound insight, compassion and empathy after personally experiencing EPP community members pain and distress attempting to live a life in darkness, the greater than 90% drug retention rate and the fact that there’s ONLY a long long long list of positive outcomes to be had by approving Scenesse. 😎
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Dr Wally
Posted on: Apr 1 2019, 02:12 PM


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Posts: 344

Absolutely anything is possible here but only once FDA approval has been accomplished. The FDAs inevitable (based on long term safety and the drugs actual therapeutic qualities) acceptance of Scenesse will completely validate it (worldwide) once and for all and allow its full potential to be realised so who’s to say 2-3-4 years post approval (because of incredible safety and efficacy) we won’t see those numbers. The interest in this drug once FDA approved will be all time.

Even here the insane potential of this company goes unnoticed, so that gives you a fair indication as to how far below the radar the company is outside of sharescene. Not many (outside of here) have a shred of understanding of the drug or its very real potential let alone seeing the big picture a few years into the future or realising that Clinuvel will be a very different company after FDA approval is attained.

The uncertainty that surrounds this enigmatic and controversial “cosmetic” “barbie” drug (exact same drug) thats been around for decades, the very drug that in 2005 was categorically refused (FDA) for reasons that have never been clarified, is simply too high for many to deal with. I actually know a few people that are waiting to jump all over it (once the companies future is 100% assured of course) the very second the FDA approve Scenesse and not before because of its “complicated and confusing” history. Oh well!😐

The authorities spend millions each and every year alerting the public to the carcinogenic dangers of overexposure to sunlight whilst the solution to this extremely serious problem has been sitting on their lab bench’s awaiting evaluation and acceptance for many years now. Malignant melanoma is a terrifying disease that’s allegedly caused by years of overexposure to sunlight. It would surely be a conservative statement to say that Millions would thankfully hand over thousands of dollars/year to protect themselves from all of the various forms of skin cancer.

Ill go out on a limb here and suggest something a little crazy: some might even appreciate the natural photo protective tone of ones skin as melanogenesis is established and during the 3 months or so that the drug is active.
We could be onto something here. 🤓
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Dr Wally
Posted on: Mar 28 2019, 11:17 PM


Group: Member
Posts: 344

Can’t believe it’s taken so many decades to get to this point hey. Am I correct in understanding that the drug was first synthesised sometime in the 70s? Maybe earlier? No wonder huge amounts uncertainty, fear of rejection and straight up scepticism of the drugs efficacy continue to linger. Only one cure for these long held beliefs andI believe it will be coming around July. 🥳

It’s understandable though I guess, if we weren’t privy to the incredible amount of information thats been shared here over the years we’d probably feel the same way. The journey/dream to have this drug accepted and it’s obvious potential to systemically protect realised has been alive way longer than I’m sure many of us here.

Tanning pills; Barbie drug and a bunch of other idiotic names and terms, that have unfortunately been associated with this drug, have given the impression over the decades that it’s a complete joke or simply a cosmetic product like some form of crappy fake tanning product that incredibly hundreds of millions of people around the globe are prepared to deal with on a weekly basis.

Spray painting your skin orange/yellow with (possibly) toxic chemicals = cosmetic joke/health hazard.

100% safe (therapeutic) stimulation of EUMelanin = photo protection perfection in its most potent and natural form = Dawn of a new era on a number of fronts.

The world will be waking up to the fact real soon that the term “cosmetic” could not be any further from the actual truth when speaking of Scenesse. Can’t wait! 😎✌🏾
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Dr Wally
Posted on: Mar 26 2019, 10:30 PM


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Posts: 344



“A nasdaq listing (and/or an acquisition). If this happens in such proximity to positive FDA announcement, 55+ is a non-dramatic realistic expectation very soon. “

Positive “realistic” talk like this is sure to put the smiles back on everyone’s faces. 😁
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Dr Wally
Posted on: Mar 25 2019, 02:46 PM


Group: Member
Posts: 344

“Another ASX-listed biopharmaceutical company to have a product application delayed (at a minimum) by the FDA recently is Starpharma Limited (ASX: SPL), despite its management team telling investors they were confident their product application would be approved.”

Thankfully its 2019 now not 2005. The FDA have worked through the mountains of data so they’d explicitly understand the science that has proven Scenesse to be way more than extremely safe. Add to that the reality that the (implant) will be cost prohibitive, strictly controlled and managed to be used only by those with severe light sensitive diseases like EPP.

The concerns of the past that have dogged this drug for decades have been well and truely quelled by the science, all’s we need now is a mature logical outlook on the situation by the regulator to see success.

I’m not saying delaying tactics won’t be applied to Clinuvel by the FDA that could possibly drag on for f knows how long, but if science, empathy, and logic have anything at all to do with their decision making process, further delays will not be happening.

Further delays or not this safe and necessary drug will not/cannot be denied for much longer!
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Dr Wally
Posted on: Mar 24 2019, 10:42 PM


Group: Member
Posts: 344

https://www.visualcapitalist.com/7-major-fl...nancial-system/

https://blogs.imf.org/2018/10/09/the-financ...nce-the-crisis/
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Dr Wally
Posted on: Mar 24 2019, 10:32 AM


Group: Member
Posts: 344

“This is what worries me the most. That we get approval and then the next crisis comes steaming through. “

FDA approval is the one thing, the only thing that matters full stop. I realise it’s been said 1 million and one times already but seriously has there ever been a truer statement made here?

Clinuvel and it’s game changing drug Scenesse (afamelanotide) will be completely validated and fully legitimised the second that milestone is reached and any lingering doubts and uncertainty about the future of this company will be fully vaporised. A better, stronger, safer position we could not be in from that day forward.

FDA approval completely frees Scenesse to become the blockbuster, life changing, cancer preventative drug that was envisaged well over 2 decades ago. Every other variant -known and unknown- will stem from its success.

Scenesses case for approval could not be any stronger.
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Dr Wally
Posted on: Mar 22 2019, 04:12 PM


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Posts: 344

Spot on. And after all these years of nothing but spectacular safety and efficacy why shouldn’t/wouldn’t they sign off on Scenesse (slightly earlier than expected) in time for the EPP community to prepare for this life changing event this coming US summer. To F these people around till mid summer or later for no good reason would be the height of stupidity and show no empathy.

It’s 2019 You’d have to believe that the FDA have completely accepted the science by now and surely their long held concerns (irrational or not) of widespread off-label Implant use would have been satisfied as well. The years of European use and data will prove invaluable here to allay any remaining concerns.
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Dr Wally
Posted on: Mar 22 2019, 02:37 PM


Group: Member
Posts: 344


Sub $20 hopefully.. After nearly 20 years the days of playing games with this company are coming to an end BUT still a number of months off. Could see some wild swings leading up. Hold tight! 😎

*Nothing (other than incessant BOT action and some irrational selling because of the fear of all the selling) has changed.*
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Dr Wally
Posted on: Mar 21 2019, 11:37 AM


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Posts: 344

Haha don’t wast too much time on it. I’m still coming to terms with the implications myself.🤓😜
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Dr Wally
Posted on: Mar 21 2019, 11:05 AM


Group: Member
Posts: 344

Disappointing! 😡 Was hoping that the fear of “something” would have escalated over night to further erode the SP today but no. Rock solid fundamentals and the realisation that many different entities have surrounded this stock on the lead up to FDA validation date, pulling it about in all directions and stirring up the remaining particles of fear and uncertainty that linger for some quick gains .

The quick recovery and business as usual shows that even with everything that’s going on with this stock it’s well known to just about everyone that Clinuvel is a super strong buy with proven credentials about to be FDA approved and sent into the stratosphere never to be manipulated by bots and short trading again. 😬😇

Im more than satisfied with my investment and have been done with buying since $8 but if someone or something could create a little panic again like yesterday to get things sub 20 I wouldn’t be looking that gift horse in the mouth for long.

Just between me and the 20-30 regulars, I did hear on the grapevine yesterday from “someone in the know” that the results from the latest double-blind placebo controlled study on Afamelanotide (Scenesse) BSCUV 6969 0045 0069 1 (that’s been running since 2005) has dermatologists from the highly reputable PAD conglomerate extremely worried that the darkening of moles will see them added the WWF endangered list by 2020. 😱😵
No wonder it tanked yesterday. Prepare for further bad, no actually devastating news!!👽☠️🤑


So much for that “canny” buy at $29 qpr! 😬..... Just kidding.👍🏽
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Dr Wally
Posted on: Mar 20 2019, 11:40 PM


Group: Member
Posts: 344

“We wouldn't be up here unless the were prepared to take out $30. Should be there in 2 hours or so...

IMHO “

Absolute classic! The kiss of death given today 30 minutes before the open. 🤣🤣🤣

Any chance you could do that again tomorrow around lunchtime? I’d love to be able to get my hands on a few more sub $20 if possible 😎

Seriously though.
The ones that clearly understand that Clinuvels fundamentals: LONG TERM SAFETY and EFFICACY: WHOLESOME, LIFE CHANGING, THERAPEUTIC, CANCER PREVENTATIVE DESTINED TO BE OF SIGNIFICANT BENEFIT TO THE HEALTH OF MILLIONS: SOLID, COMMITTED, PRUDENT COMPANY MANAGEMENT to name a few **HAVE NOT CHANGED 1 BIT** laugh when this kind of irrationally takes place and possibly take advantage of the situation by buying a few extra at the discounted price. With a number of months to go theres plenty of time for much stupidity to take place yet I reckon . This BS won’t be happening post FDA approval that’s for sure.😎
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Dr Wally
Posted on: Mar 19 2019, 03:12 PM


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Posts: 344



29.980 Boooooooooooo! 🤣

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Dr Wally
Posted on: Mar 19 2019, 02:28 PM


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Posts: 344

Hopefully their bluff gets called and they loose the lot of them! They’ll be kicking themselves in a few months time.

A more loving and appreciative home awaits these precious CUVs. 🤓
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Dr Wally
Posted on: Mar 19 2019, 12:55 PM


Group: Member
Posts: 344


75,000 plus pre approval = Smart buy. Where else are you going to be able to double (at least) your hard earned over the next 12 months other than investing it right here with the skin care specialists Clinuvel!

Would it be nasty to say that: Anyone that can’t appreciate the fact that FDA approval of the ultra safe Scenesse will send Clinuvel stock into hyperdrive doesn’t deserve any. 😬
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Dr Wally
Posted on: Mar 18 2019, 08:10 AM


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Posts: 344

Props for going to the effort of explaining that link clearly to all. I feel some people believe that it’s just the same old 20-30 posters visiting here day in day out that. Couldn’t be any further from the truth. Information is power. 👍🏽


“Hostile take overs are a different story and x-ray is right to not ignore it.”

Yes it’s a good idea to prepare for any and every possible situation. Hostile takeovers take place when companies are (thought to be) going down the wrong path by others with power that believe they can do a better job at running things. Does that sentiment exist here?. If this forum is anything to go by there must have been some with power doubting the direction and progress of Clinuvel over the years?
  Forum: By Share Code

Dr Wally
Posted on: Mar 17 2019, 12:33 PM


Group: Member
Posts: 344

“Xray is constantly talking about a takeover, he seems obsessed with the idea ☺️”

As long as I’ve been here he’s been threatening a T/O.😑 The thought of it gave me night terrors for years but if it hasn’t occurred by now is it even remotely possible in 2019 without many many multiple billions being put on the table for this one of a kind drug?

After patiently waiting all these years, understanding explicitly the very real potential and future of the drug in one form or another (implant - topical) with no reason at all for it not to become an essential, game changing dermatological product within a few short years of the all important FDA decision, $81 would be nothing short of an insult surely.
Why would the board and major SHs with all their specific knowledge of what’s to come even speak to any offer below $200 in 2019?

It’s not that hard to imagine this company in 3-5 years time. Clinuvels ultra safe drug Scenesse enabling 10s, 100s thousands of individuals effected with light sensitive diseases to literally come out of the darkness to live a full and normal life beneath sunlight then add to that dramatically changing the lives of 100 thousands/millions suffering the the nasty effects of vitiligo. The implant (Scenesse) is really just the tip of the iceberg for this company.
Now consider the topically applied melanocourtin/photo protective/therapeutic thats guaranteed to see multiple millions of sales per year and growing exponentially year on year until genetic modification becomes reality and renders the super safe melanocourtins (and just about everything else) useless, maybe. 20-25 years 🤓

It’s not 2005 anymore. The irrational fears of that time have been erased by 14 long years of nothing but positive data on Scenesses safety and efficacy and just as important the understanding that this product is the polar opposite of a cosmetic.

An incredibly wholesome soon to be super successful multi billion $$ company is what we’ve invested in here and the rest of the world is just waking up to the fact. Exciting times!😎




https://www.aad.org/public/diseases/other-c...rma-pigmentosum

Dermatologists are helping advance medical care for XP
To improve the lives of their patients with XP, dermatologists continue to study this disease. Their work has led to:

Improvements in sun protection
The discovery of medications that can reduce the risk of developing skin cancers
Insight into how skin cancer develops and can be prevented

This research can help everyone, not only their patients with XP. We all have sun-sensitive skin. Every year, millions of Americans develop skin cancer.

Sun protection helps everyone prevent skin cancer
While people who have XP require extreme sun protection, everyone can benefit from sun protection. For most people, skin cancer is preventable.
  Forum: By Share Code

Dr Wally
Posted on: Mar 16 2019, 12:48 PM


Group: Member
Posts: 344

I feel most people would logically assume that ALL trading of publicly listed shares in a publicly listed company would have to be bought or sold in the same way, with the same amount of risk attached to the process, as they themselves would have to engage in and deal with when offloading or purchasing shares on the ASX.

Obviously these multi million dollar deals can be done behind the scenes and are totally legal??

I just don’t get how deals like this go down like this without some kind of ASX announcement? So much for transparency. 😑

Maybe it was a good thing for CUV that that amount of shares were exchanged in the manner they were??

Not trying to cause fear or alarm, I’m 99% sure everything was done above board, just curious about the process is all. 🙂
  Forum: By Share Code

Dr Wally
Posted on: Mar 15 2019, 04:51 PM


Group: Member
Posts: 344


Very -no let me say absolutely true about the science and it would be no shock to me to see this hit $290 within a few years now that would be “uncanny but highly possible imhbuo. Incredible potential with no downsides. FDA green light is just the begging.😎


Imhbuo = in my honest but uneducated opinion.
  Forum: By Share Code

Dr Wally
Posted on: Mar 15 2019, 04:37 PM


Group: Member
Posts: 344

Is there anything that can be learned about this situation from the “course of sales” this afternoon?

Dribs and drabs all day leading up to 4pm and at 3:59:59 we were sitting at 29.7000

then at 4:10::44 we dropped to 28.8100 after a 428 share sale.

There ended up being 103 separate sales @ 4:10:44 ranging from 10s to multiple thousands to tens of thousands and one sale of 102,177

then 353 sold at 4:20:04

@ 4:33:08....... 43,149 were exchanged for the same price 28.8100

What happened here? Is this a positive or negative event?

If this was a pre arranged deal why were there 105 separate parcels instead of one or a few that were offloaded/bought?


Share market L plater here. 🤓

Even though I know SFA about the SM I’d be extremely confident that PW selling shares (any amount of shares) at this point in time would surely be an insane situation. Not possible if mentally stable
  Forum: By Share Code

Dr Wally
Posted on: Mar 8 2019, 12:08 AM


Group: Member
Posts: 344



Hooooly sh1t! 😬 Lets hope the FDA don’t get wind of this recent study outcome.

https://www.vox.com/future-perfect/2019/3/5...hicle-dark-skin

“A new study finds a potential risk with self-driving cars: failure to detect (dark-skinned pedestrians”).

“If you’re a person with dark skin, you may be more likely than your white friends to get hit by a self-driving car, according to a new study out of the Georgia Institute of Technology. That’s because automated vehicles may be better at detecting pedestrians with lighter skin tones. “

Is this undeniable proof that technology really is racist?🙀

This story is on the same page “Vox.com” page as “the new Ketamine treatment for depression” that was rushed through the approval process after only a few short studies showing inconclusive efficacy and minimal safety data strangely enough.

Incredibly Safe Scenesse still awaiting FDA acceptance. The timing of this news is uncanny to say the least.

Get out while you can!!🤓
  Forum: By Share Code

Dr Wally
Posted on: Feb 28 2019, 07:59 PM


Group: Member
Posts: 344

Fair and sensible call but we all know what’s going to happen around July. 😎😎😎🥳🥳🥳
  Forum: By Share Code

Dr Wally
Posted on: Feb 12 2019, 03:23 PM


Group: Member
Posts: 344

WOW!!! 🙉🙈🙊

It would have been one hell of a sh1t hot marketing move if they’d have gotten him on the Scenesse bandwagon before he passed on X. Might not have the same impact after a decade gathering dust in his crypt though but who would really know in this celebrity mad culture. No such thing as bad publicity right??😬


That “bubbles” by the way.
  Forum: By Share Code

Dr Wally
Posted on: Feb 5 2019, 10:47 AM


Group: Member
Posts: 344



“Maybe Trump uses Scenesse “

Whatever he’s been most unfortunate to have been applying to his face for god knows how long is EVERYTHING that SCENESSE IS NOT.😎
  Forum: By Share Code

Dr Wally
Posted on: Jan 20 2019, 01:20 PM


Group: Member
Posts: 344

Seemingly a few years off yet but proof of concept has been well and truely confirmed it seems. I bet they won’t get the extended regulatory F around like Clinuvel has had to go through. Good for them. So many exiting breakthroughs going on everywhere atm.

Are you kidding! 🤓 $200-300/share is only a few years off also.

The world is going to be shocked big time when they realise that the fabled natural, cancer preventative, photo protective, therapeutic and completely safe tan that they’ve heard whispers about for 3 decades now has become reality. Exiting times indeed.

It feels good to have a stake in a wholesome company like Clinuvel. Their completely safe drug is destined to alleviate serve pain and give a full life to thousands of vulnerable people with no other options and one day provide the ultimate in photo protection to multiple millions and preventing skin cancer like nothing that has come before.

This drug might even put you out of business. Lucky you’ve covered your ass with a sh1t load of Clinuvel. 🤓

I don’t feel that it’s a bad thing or detrimental to anyone’s cause to be talking like this in 2019 simply because if the FDA is coming here for information then the world really is f@cked. Completely F@cked!! 😑
These guys have been struggling with and contemplating the realities of approving this drug for a good decade at least but they’ve realised probably a few years ago now that tanned skin isn’t the work of the devil and that the benefits of this long awaited game changing drug completely outweigh any negatives. Is there even 1 negative to this drug??

Only thing I can think of is the possibility, because the drug is so photo protective, that low D levels could be an issue?
  Forum: By Share Code

Dr Wally
Posted on: Jan 20 2019, 12:22 PM


Group: Member
Posts: 344

“”Was going to say same thing. Like insulin, a peptide cannot be delivered PO (per os) or by oral route. “”

Individuals with type 1 diabetes must inject themselves with the required dose of insulin daily to manage their condition. In the future, injections may no longer be necessary; scientists are developing a viable way of delivering insulin in pill form.

https://www.medicalnewstoday.com/articles/322258.php

“”1. Peptides are fragile, need to be injectable or transdermal,””

“PO peptides it appears will be far off and not available for every sequence”


“Peptides, short amino acid chains that control many functions in the human body, represent a billion-dollar market, also in the pharmaceutical industry. But, normally these medications must be injected. A research team led by the Technical University of Munich (TUM) has now determined how peptides can be designed so that they can be easily administered as a liquid or tablet.”

https://www.sciencedaily.com/releases/2018/...80221122406.htm

Keeping up with the latest scientific breakthroughs in these times of fundamental change must be difficult when your busy working long hours and managing a monstrous holding of Clinuvel. 😉

I have faith that the expert team at Clinuvel would be all over these advancements. 😐


“Unless Iggy was personally administering the drug I would not worry.” Buuuuurn IGGY! 😂😂
  Forum: By Share Code

Dr Wally
Posted on: Jan 19 2019, 09:30 PM


Group: Member
Posts: 344

“Dr Wally, a pill beats the needle on every measure. “

No that’s incorrect. You obviously didn’t read my post thoroughly IGGY. Sure the pill is superior in just about every way (you would think) other then the critical ability to be able to 100% guarantee the optimum photo protective dose of Afamelanotide obviously because it cannot eliminate human error like the implant does.
To attain the constant and necessary blood levels of afamelanotide that the implant provides you would have to think that multiple pills per day would have to be consumed and there entails the problem with the pill.

“It’s a no brainer; the pill totally eliminates any infection risk and also the possibility of a nasty keloid scaring effect occurring because of the large needle needed for the Scenesse implant. “

The risk of infection at the injection site would have to minuscule at best and the possibility of “nasty keloid scaring” is hilarious even if a tiny nick from a scalpel is needed for the implant insertion. Your making out that the implant is massive when It’s widely known that the implant is the size of a grain of rice. Cmon IGGY your going to have to try harder than that my friend.

When is the micro needle transdermal patch going to rear it’s head??? We shouldn’t be facing all this competition. Scenesse should have been approved like 5/freaking years ago. We should be multi billion dollar company at the top of its game by now but instead we still wait and the competition gets a free ride on Clinuvels coat tails threatening our future success. F@rking BS.🤬
  Forum: By Share Code

Dr Wally
Posted on: Jan 19 2019, 04:20 PM


Group: Member
Posts: 344

“If they do advance MT 7117 into phase 3
and if the get NDA approval it could hurt Clinuvel because an oral pill is so much more convenient.”



It may be a convenient and simple way of ingesting Afamelanotide but when 1000% photo protection is needed for preventing severe pain (from even minor UVR exposure) and the accumulative damage that can lead to organ failure and possibly death, Afamelanotide in implant form is the fail safe way to go for the ultimate protection especially for EPP children. Missing doses here and there which is what would inevitably happen (only human) is a recipe for disaster as well as a way for people to be able to blame the drug for any adverse events and not their own forgetfulness.

For any of the diseases that need superior and absolute photo protection to enable the person to live a normal life outdoors a monthly injection of the Scenesse implant is the only way to go and a small price to pay when considering the nasty consequences of getting the dosage wrong. Surely that is the primary reason they went with the implant as no other way can guarantee the photo protective dosage will actually be attained.

Pill form (is it even a viable option??) Afamelanotide would be a massive threat to Clinuvel and their topical/transdermal formulation for the millions inflicted with the terrible disfiguring effects of Vitiligo as well as for the photo protection of the many millions suffering from varying levels of melanin compromised skin (hypomelanosis 🤓).

Surely to F@*& Clinuvel would have had this angle covered a decade or so ago if it was/is at all possible yes??) EDIT- It must be one of the new model peptides that are effective when taken orally?
Seems this wasn’t possible till just recently BUT obviously Clinuvel were and are on top of this situation??

“Peptides, short amino acid chains that control many functions in the human body, represent a billion-dollar market, also in the pharmaceutical industry. But, normally these medications must be injected. A research team led by the Technical University of Munich (TUM) has now determined how peptides can be designed so that they can be easily administered as a liquid or tablet.”


https://www.sciencedaily.com/releases/2018/...80221122406.htm


On a similar subject. Having these expert centres is a cumbersome, time consuming and extremely expensive burden on everyone involved in the process. It’s obviously a necessary step to appease regulators and to allay their (overblown) concerns of possible abuse even though the drug is long term proven extremely safe but ya gotta do what ya gotta do and gaining the all important FDA approval is the only thing that matters right now isn’t it.

The drug will prove itself in no time and logic and common sense should take care of the rest so you would have to think that the logical progression after say 12 months post FDA approval would be to have Scenesse implants sent out to the patients personal physician in their home town for implantation. Before you poo poo the idea IGGY, If a qualified medical doctor couldn’t easily administer a small Scenesse implant then they really shouldn’t be practicing medicine at all should they!

Taking that simple step would cut costs dramatically and eliminate EPPers travel time and expense. Theres no reason whatsoever that integrity (off label fears) would be compromised in any way if this system was implemented and it’s not like the drug is at all dangerous to anyone.
  Forum: By Share Code

Dr Wally
Posted on: Jan 15 2019, 12:58 PM


Group: Member
Posts: 344

If you try to compare this company with anything else out there you’ll be doing yourself a huge disservice. It’s been a long and twisty, mind bending road to approval sure but once the last of the resistance is neutralised (fda approval) the sky really is the limit. There’s not many companies with this kind of potential getting around that I can see atm.

Regulator uncertainty has/is keeping so many out of this even now at this late stage even though it’s future is virtually guaranteed. The fabled story of the safe drug that will naturally and safely tan skin and prevent skin cancer is one that everyone has heard off and one that’s been spoken of for decades now. Enigmatic is one word for it.

Everyone (other than my partner) that I speak to about it believes there’s something a miss with it simply because if it were as perfect as I make it out to be then surely it would have been approved by now. Until they sign off on the paper work a strong feeling of “ will they really approve a tanning drug” sentiment will remain for most uneducated people.
  Forum: By Share Code

Dr Wally
Posted on: Jan 15 2019, 10:58 AM


Group: Member
Posts: 344

“Personally, I'd be very happy with 60 aud in 5 years. “

The very second the uncertainty and scepticism (based only on the unjustly long approval process) are vaporised by the FDAs approval of Scenesse the SP will undoubtedly be heading north at a speed rarely seen. Sure everything goes up and down to an extent but there’s no way that Clinuvels SP will drop and fade like it has over the years simply because once FDA approval is given literally no obstacles remain to get in the way of an incredible future full of growth. The uncertainty that many still see (even now) will be gone and everyone will be wanting a piece of the pie.

Clinuvel is a wholesome company with a essential cancer preventative product that will eventually be utilised by millions of people of every skin tone.

Good luck to you guys wanting to short! 😜 Time for those games is fast coming to an end. 🤯🤯

If things pan out $60 before the year is out is not at all out of the question. Who really knows where things will go as the media frenzy once approved will be totally insane.

FDA acceptance and approval of Scenesse is only the beginning and we have been privy to enough information and discussion over the years to understand and realise that there’s a decade at least of exiting growth for Clinuvel to come and on many different fronts.

Safety is at the core of Clinuvel success and as we all know very well, that subject has been of no issue to regulators for many years now.

It’s going to be a spectacular year.

I Have to admit that I was shocked to see that Priority Review was granted. Even though I knew that Scenesse qualified in every area and that one day it would be approved, I was certain that it (PR) wasn’t going to happen. The resistance is finally coming to an end at last.

One journey is coming to an end but another more exiting one is about to begin.

About Freaking time too!

Happy new year. 🥳🥳🥳
  Forum: By Share Code

Dr Wally
Posted on: Dec 21 2018, 08:19 PM


Group: Member
Posts: 344



“Suppose now I’ve got to go out shopping to make amends.”

Hahaha IGGY you really are the Clinuvel CUV sharescene grinch aren’t you mate. 🤣
You’ve got me stumped. I’m not quite sure if your actually clued up and making an earn off of CUVs fluctuations or you really are as silly, grumpy, irritable and ignorant as you make out.

  Forum: By Share Code

Dr Wally
Posted on: Dec 20 2018, 04:01 PM


Group: Member
Posts: 344

“They are better off pursuing other rare indications till they can run a good vitiligo study and there are some better run companies with Vitiligo programs which may raise the bar too. “

. They simply have to gain US approval for EPP. Everything else will fall into place rather quickly after that ground breaking decision is eventually extracted from the FDA. EPP approval is the ONLY thing that matters and Afamelanotides (Scenesse) indisputable safety will ensure its approval and success. 😎 Everything else is fluff and puff. 🤓
  Forum: By Share Code

Dr Wally
Posted on: Dec 11 2018, 09:53 PM


Group: Member
Posts: 344


“Don't know about everyone else but the one that will come right before and **after FDA approval** is looking more and more like a time to offload some shares. “

I completely understand your frustrations with everything Clinuvel but you don’t really think this do you? Surely your taking the p1$$!? 😉
Selling after FDA approval will be the biggest financial mistake you could ever make. You’ll be kicking your own ass for the rest of your life if you follow through on this. FDA approval is the one and only thing that matters here and everything changes for the better from that day on. It would be a real shame to loose your sh1t at this late stage of the game.

Sure without FDA acceptance the dream becomes a nightmare but if the slightest amount of logic exists in this world, the drugs exemplary safety will see Scenesse approved and an incredibly successful future for Clinuvel and its loyal and foresightful investors will be realised.


EPPers aren’t serious because they havnt gone to the extremes of using MT2.
Why IGGY whhyyyyyy!! 😫😫👽
  Forum: By Share Code

Dr Wally
Posted on: Dec 6 2018, 09:36 PM


Group: Member
Posts: 344

The Economic Proof That The FDA's Drug Regulation Makes Us All Poorer😑

“the glacial speed of the FDA's bureaucracy is a cost imposed upon us all.”
  Forum: By Share Code

Dr Wally
Posted on: Dec 4 2018, 12:34 PM


Group: Member
Posts: 344

I’m no spinner Im just trying to allay people’s fears by countering your ridiculous fake news attacks. It doesn’t take 2 minutes to do.

My postings, as repetitive and basic as they maybe, are angled at people that might be new to this whole “tanning” Scenesse, Clinuvel space. The confusion that surrounds this drug and company in 2018 is incredible and having you twisting and muddying the facts doesn’t help now does it!


Scenesse= good, game changer, life saver/changer, physical “melanin” barrier to sunlight preventing UV overexposure , systemic natural endogenous UV protection, cancer preventative, therapeutic for numerous diseases, long term safe beyond doubt, carcinogenicity waiver given by FDA, much more to be announced.

FDA = confused maybe, probably more likely conflicted but coming to terms with the future of Afamelanotide and photo protection and 👹 skin tanning 👹. Resigned to the reality that extraordinary safety profile of Scenesse guarantees approval at some stage and are comfortable and happy about it.

Ignoramus = enigmatic shyster! Known promoter of cemitidine for EPP over proven Scenesse says everything 😑 probably a very nice guy when not trying to scare the Clinuvel SP down.
  Forum: By Share Code

Dr Wally
Posted on: Dec 4 2018, 10:19 AM


Group: Member
Posts: 344


“I doubt that the FDA would think there is any need to rush the approval of a tanning drug.”

Thanks for stating the bleeding obvious Nostradamus, your thought provocating insights never fail to amuse. You must be confusing the sh1t out of the FDA bureaucrats that frequent this forum looking for information on Scenesse though 🤓
  Forum: By Share Code

Dr Wally
Posted on: Nov 20 2018, 03:21 PM


Group: Member
Posts: 344

Little bit dramatic don’t you think Egore or is it X-ray? 😉! If you think anything that’s posted here is not already explicitly known by the authorities and regulators, 20 years ago, then think again.

And what is so devastating about people being able to have access to a drug that safely and effectively stimulates a photo protective tan anyway? Settle down mate it’s not as horrific as your making out. The safety of Scenesse will make advocates out of resistant regulators if it hasn’t already.


“The FDA letter in 2005 stated it would not approve a tanning drug.”

So how the f🤬ck is Clinuvel ever going to get Scenesse approved then? It tanned the skin for photo protection in 2005 and it continues to tan the skin now.

Don’t be afraid of the tan Egore. There is such a thing as a safe tan you know. 😎
  Forum: By Share Code

Dr Wally
Posted on: Nov 20 2018, 03:03 PM


Group: Member
Posts: 344

“The FDA has already gone a long way to giving Scenesse a pass on safety.”

Of course they have. How could they not? Just because your opposed to something doesn’t mean you can forever deny the reality that’s been proven for a decade or so does it?

It’s prophylactic nature will obviously prevent skin damage and skin cancer, it’s also therapeutic in a number of ways. Plus it seems certain theres much more that hasn’t been spoken of as yet judging by the information that Uhonic puts up on his site.

Anyone arguing against Scenesse efficacy when they know that the treatment is actually allowing people that are absolutely light intolerant to lead a normal life out in strong sunlight, is not being serious for some silly reason yeah! 👽

Once FDA approval is accomplished the information floodgates will open.
  Forum: By Share Code

Dr Wally
Posted on: Nov 20 2018, 12:33 PM


Group: Member
Posts: 344

“Is Scenesse the less effective tanning cousin of MT2?”

Yes it is actually. Research the difference between MT1 (Afamelanotide) and MT2. There two very similar but different molecules.

People that use mt2 don’t usually hold back from going out in the sun. People that have EPP probably wouldn’t be so keen considering the consequences that have followed UV exposure. If they did they’d go extremely dark as well.

I don’t understand how it works but getting UV exposure after your body reaches a certain level of synthetic aMSH turns the slight tanning of your skin pre UV exposure to extremely dark in no time if your not careful. This is why it will actually stop people laying round attempting to tan till they’ve gotten burnt and done damage. Even though that’s virtually impossible when you’ve reached your optimal level you just get darker and darker.

Think about it; epp sufferers can go out and get hours of UV exposure.

Not many people will want to go to those colour extremes though. Why would you bother laying round roasting in the summer sun if you’ve got a tan already? . People that body build love getting as dark as possible though. minimal UV exposure over a few days is all they need and their protected at the same time. Win win for them.

Cmon IGGY.🤓

WTH! Call it what you want Macgyver just don’t fool yourself ok. That’s very important. 🤟🏾
  Forum: By Share Code

Dr Wally
Posted on: Nov 20 2018, 10:16 AM


Group: Member
Posts: 344

“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.”

Clinuvel are attempting to get a drug that tans the skin accepted and approved in an environment where many authorities still state that all sunlight is bad, that minimal amounts will cause melanoma and recommend that sun protection cream be warn indoors. The rhetoric hasn’t changed much since its inception in the eighties. It’s completely unbalanced bordering on insane to still be thinking like this in 2018 but it’s a complicated and controversial space that is about to see huge changes take place.

The authorities and regulators are finding it hard enough as it is to come to terms with this game changing technology (some resorting to blatant corruption -NICE- for example to stifle progress and access) so to get in their face with conflicting views at this point in time wouldnt do anything to help their/our situation it would only makes thing more difficult. Its the very reason why Clinuvel have kept the hype to a minimum over the years even though it’s frustrated shareholders and made management look incompetent.

Until Scenesse (Afamelanotide) is accepted and approved by the FDA Clinuvel will run with the 4 decade old rhetoric as outdated ridiculous as it is. This drug is going to blow this “tanning” space to bits and completely disrupt and eventually destroy a billion dollar sun scam industry that actually donates millions to government agencies that in turn promote their ineffective benefits to the public. Toes are being trodden on, the status quo is under threat and many millions of dollars are at stake here.

As has been said 1001 times: the safety of Scenesse will force the FDA to approve it at some stage. They simply cannot deny it’s safety and the incredible benefits to health forever. Paradoxically the same agency’s that have stonewalled Afamelanotide for so long will be promoting its wide range of benefits in time.

There is such a thing as a safe tan!
  Forum: By Share Code

Dr Wally
Posted on: Nov 18 2018, 03:03 PM


Group: Member
Posts: 344



“This would make an excellent marketing campaign for Scenesse”

Haha good on ya Johnytech. What about:

*** Reverse evolution within a fortnight with Piers Afamelanotide Cream. ***

Not quite sure if the whole “evolution” angle would come across as being a good thing or a bad thing in this PC obsessed world right now.

I wonder what the alt-right and NAACP would make of it all? 😱

On second thoughts we might try a different marketing strategy Johny. 🤓


  Forum: By Share Code

Dr Wally
Posted on: Nov 17 2018, 11:56 AM


Group: Member
Posts: 344

To be able to wind back thousands of years of evolution, enabling light skinned melanocytes to fully function again in a matter of 10-14 days in a completely safe manner by stimulating the most efficient and effective natural photo protection (eumelanin) is still mind blowing to me. When all is revealed and the implications are fully understood Afamelanotide (Clinuvel) will surely be worthy of a Nobel prize in medicine one day.


The story of Clinuvel and their epic journey to have this extremely controversial and enigmatic “tanning drug” understood, accepted and eventually approved by the most powerful of regulators (that 15 years prior had explicitly told the company there would be minimal chance of approval) is a story that will make, not sure about a movie, but definitely an extremely interesting multi part documentary on so so many levels. 😎
  Forum: By Share Code

Dr Wally
Posted on: Nov 14 2018, 09:27 PM


Group: Member
Posts: 344

“I think the woman asking the questions was a bit overwhelmed by Wolgen’s cool charm and handsome appearance”

It’s 2018 Iggy, you can confess to your mates at Sharescene that you find Pier cool and handsome without fear of ridicule . There’s no need to throw off onto “the woman”. 😸
  Forum: By Share Code

Dr Wally
Posted on: Nov 13 2018, 01:51 PM


Group: Member
Posts: 344

“I cannot see how the US pharma industry would be happy to see this kind of costly draconian measures becoming FDA fashion. “

They surely wouldn’t but I suspect that this suggestion (ploy) by Clinuvel is simply to show that they have no fear whatsoever for the safety of Scenesse, signalling to the FDA that being strictly monitored post approval is of no concern to them.

The safety angle is a constant ever present danger that a stubborn, ignorant regulator, not happy conceding to a drug that they’ve feared and opposed for decades could possibly fall back on to further stonewall or if they felt it necessary, put said drug on ice for good. Getting on the front foot and attacking that possible safety avenue is a strong, positive move and couldn’t possibly hurt could it? Initiating this before the FDA place their own form of time and money consuming post approval surveillance program sends the message to the FDA and all concerned, that Clinuvel are absolutely confidence with the long term safety of Scenesse. At the end of the day it’s safety above all else that will guarantee success here and that’s the one indisputable thing Scenesse has bucket loads of, a fact that’s actually been confirmed by the FDA when they issued their “carcinogenicity waiver” a few years back.


14 years after they stepped in with their concerns it must be extremely likely that in 2018 that they’d now fully comprehend the multitude of benefits Scenesse and Afamelanotide will bring to the community. Being privy to all the scientific data, the multitude of studies, and real life anecdotal evidence throughout the slowest ever “fast track” rolling review it would be impossible for their views and outlook not to have changed for the better but could their views have changed that dramatically that they’ll allow 16 weeks to be taken off the epic journey to approval? If logic and common sense exists within the agency then it could be a real possibility and a PR might not be out of the question. It couldn’t happen could it?🙏🏾🙂


“A priority review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.”

“A priority review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.”

“or evidence of safety and effectiveness in a new subpopulation, such as children.”

“RThe FDA goal for completing a priority review is six months”
  Forum: By Share Code

Dr Wally
Posted on: Nov 11 2018, 05:23 PM


Group: Member
Posts: 344

“PTN has an accepted NDA for bremelanotide (licensed to AMAG Pharma), with a PDUFA date of March 23rd 2019, as an on-demand SQ injection for hypoactive sexual desire syndrome in premenopausal women.”

“I just don't understand the needless and repeated obfuscation with Clinuvel”


There’s 2 options I guess. Either Clinuvel management are ridiculously inept and getting this absolutely safe and effective drug to market after 13-14 years, has been/is above them. If this is true then maybe they really have made a catastrophic mistake somewhere with the Scenesse NDA and this glacial journey is going to drag on throughout 2019-20-21 or latter or maybe NEVER, OR

their doing a fair job considering how controversial, irrational and steeped in negative connotations the whole subject and space surrounding skin tanning and sunlight is. It was made clear back just before Clinuvel took over that there was some kind of unsurmountable issue at play and they were going to have to radically change their business model and take a completely different approach to things if they were to stand any chance of having their tanning drug accepted and approved in the future. How could you not be guilty of obfuscating when the regulators have made your path so difficult for so long?

They’ve come along way in the face of adversity I believe.


I think it’s pretty obvious that FDA approval for the implant opens the door to the mass use of Afamelanotide, in a transdermal formulation, be it in 2 years or 20 it couldn’t happen without the implant being accepted. With the game changing potential of Afamelanotide starting to dawn it’s no wonder that the usual rules and regulations have been thrown out the window by regulators that probably have some lingering concerns about a Afamelanotide future but you would hope that in 2018 all their concerns of 2004-5 have been eliminated. 13-14 years have now passed since then and a wealth safety data has been accumulated, the very real potential to halt escalating skincancer rates and a long list of therapeutic possibilities have been identified but foremostly a vulnerable and needy group of EPP patients are patiently awaiting this safe life changing treatment.

What is there to fear from a safe photo protective tan? 😎
  Forum: By Share Code

Dr Wally
Posted on: Nov 11 2018, 02:52 AM


Group: Member
Posts: 344

** Post from HOTCOPPER **
** MemberCUV101 **

I read this   AFR Article and thought of what an impressive investment case Clinuvel has become. Michael Heine (who is being interview here) is a new billionaire having floated his company Netwealth in the last year. This doesn't take into account any new indication or new products which may or may not happen. ASX 200 and some analyst interest could see Clinuvel kick again.

"Every company is different and therefore one needs to determine what is important and relevant in a particular situation but some of the things that are important to me when investing in, or managing a company are:The company should have a model of recurring income rather than be deal-oriented. Investors place a higher value on a steady and growing income."
-Currently over 95% of patients return year after year. Long term repeat use demonstrated in Swiss and Italian data. No cure for disease in the foreseeable future.

"I like companies that have a bigger gross margin than a company with a high turnover but with skinny margins."  
-50% margin last financial year and increasing margins with larger market penetration (over 70% margin last quarter)

"It is important that reported profit is highly cash-generative and not just accounting profits. Cash is need for reinvestment as well as paying dividends to shareholders. I don't like companies that do not generate cash in the bank!"
-All cash. Dividend paid and cash pile growing nicely.

"Companies should have little or no debt. Debt is not all bad but must be well managed and conservative."
-No debt

"Good, proven management whose interests are also aligned with shareholders is important."
-CEO now largest shareholder. NED and probable next chair just popped in 13 million cash of his own money. Management is indeed very stable.

"The industry the company operates in should have a strong future and not be susceptible to market disrupters. Or is the company the disrupter that is going to take market share from the incumbents?"
-Health funded by governments or government backed payors. Orphan designation gives protection for 6-7 more years in EU and 7 years from approval in US

"How do you measure the value of a non-income-producing growth company?At zero!"
  Forum: By Share Code

Dr Wally
Posted on: Nov 8 2018, 11:16 PM


Group: Member
Posts: 344

“If you’re a stickler for the rules then by rights an RTF should’ve been granted”

What rules? Not much about this long winded journey to get this safe and effective drug accepted and approved is comparable to any other drug past or present from what I’ve witnessed in the time I’ve been involved with Clinuvel. The delaying tactics that some regulators have applied to Scenesse have been completely scandalous. It has not been a level playing field for Clinuvel for some unknown reason. NICE anyone!

Concerning the non existent RTF letter: logic strongly suggested that because the FDA had been in close collaboration with Clinuvel for so long on a rolling review basis that the idea that something significant enough to have triggered a RTF situation could have somehow slipped past the FDA bureaucrats beady eyes seemed totally ridiculous and that’s coming from someone that feels that many regulators have an ideological objection to the drug. Imagine how cynical and dodgy the FDA would have looked if they had RTFed Scenesse after all the hand holding that took place. Anyway where are we going with this conversation😑.

No RTF, market regaining confidence, SP on the rise again, NDA acceptance imminent, competent management, financial success already and we havnt even begun, Scenesse approval certain to happen at some stage, happy dayz approaching 😎
  Forum: By Share Code

Dr Wally
Posted on: Nov 8 2018, 08:58 PM


Group: Member
Posts: 344

WTF! What would you want to say privately that you couldn’t say here for all to see? I don’t get it sorry. I’m only interested in Clinuvel related subjects that might be of interest to all. Tell us about your FDA filling status theory right here.

Going IM would turn nasty real quick with a guy that I know is pretending to be someone other than the much loved Reality Check that loved this type of BS filling up the pages with unrelated crap. Not interested.

Also I don’t understand your support for this weird request Macgyver? Whats up with that? 🤯


Earlier today I meant to say that “you can bet yr a$$ the standard review will take longer than 10 months to finalise when it eventually happens. 😑
  Forum: By Share Code

Dr Wally
Posted on: Nov 8 2018, 08:01 PM


Group: Member
Posts: 344

Hahaha! I think you’ve confused Johny H with that narcissistic and at times paranoid forum member Reality Check/Chump? Or have you! 🤓
———

JH says:
“Sharescene is a very valuable resource for retail investors, and, most likely, institutional fund managers as well.”
“This place is an information clearinghouse for Clinuvel investors. “

Hey Johny H, you obviously realise that many people come here looking for advice so why do you state your opinions so strongly as fact? Your over confidence and brazen attitude would be very misleading to many. Is that your game plan?

I was stupid enough to believe Reality Checks BS a few years back and purchased shares for a much higher price than I should have so it annoys the crap out of me when I read things like you’ve posted below about important subjects concerning Clinuvel.

“Important takeaways:
-Clinuvel got an RTF”

“The existence of an RTF letter won't become public record unless Scenesse is approved and published, but can be presumed as fact.. “

“And YES, Clinuvel got an RTF. They can call it whatever they want in their press releases, but that's what happened.”

“I'm well aware that this statement is going to be unpopular here, but let's be very clear:

“Clinuvel has received a Refusal to File letter.”

“You can put lipstick on the PR pig, but that's what happened. I find their lack of honesty very frustrating. They didn't get a letter requesting more information: it has a formal name. REFUSAL TO FILE. “
  Forum: By Share Code

Dr Wally
Posted on: Nov 8 2018, 11:27 AM


Group: Member
Posts: 344

“Surely we must hear something before the end of the year, no? “

Who would know really. We can only hope. 10 months (you can bet your a$$ it’ll be much longer than 10 months regardless, but FDA approval is going to be such a massive event that it’ll be well worth the glacial wait. That one decision will open the door to all other Afamelanotide possibilities. Disruption of a space on a level rarely seen is going to be massive news for a long time.

It will be very telling he next time we hear back from the agency. We should be able to accurately gauge the mentality of the FDA in regards to their complete acceptance and preparedness to get out of the way and accept this super safe and effective drug OR if some long held fears are still present and the stonewalling of Scenesse will continue for a while longer.
  Forum: By Share Code

Dr Wally
Posted on: Nov 8 2018, 10:42 AM


Group: Member
Posts: 344



Tell me more!! 🤓
  Forum: By Share Code

Dr Wally
Posted on: Nov 8 2018, 10:34 AM


Group: Member
Posts: 344

There is no logical reason why PR SHOULDNT be given but I cant see it happening simply because there would still be some within the agency that aren’t completely sold on the concept or not prepared to let go of their long held fears of a tanning pandemic after the approval of the tanning drug Scenesse so I can’t see them wanting the process to be speed up tbh. Remember what happened in 2004-2005?

6 month - 10month makes little difference after all these years waiting.

Any chance you could explain why you 100% guaranteed on more than one occasion that Clinuvel had received a RTF letter??
  Forum: By Share Code

Dr Wally
Posted on: Nov 8 2018, 10:01 AM


Group: Member
Posts: 344


The realisation that the dreaded RFT letter was just a figment of some people’s frustrated minds is starting to show. Clinuvel is stronger than ever with FDA approval (probably not PR) 99.9999% certain as regulators come to terms with the many benefits of this incredible and most importantly SAFE drug. Onward and upward. 😎.

  Forum: By Share Code

Dr Wally
Posted on: Nov 6 2018, 09:45 PM


Group: Member
Posts: 344


“I picked the wrong week to stop sniffing glue, because this just isn't making sense to me when I'm not high on glue. “


Hey Johny be careful sniffing that toxic sh1t it’ll turn your brain to mush. That egocentric whack job Reality Check posted here a while back that he was doing the same thing (sniffing glue) strangely enough. Look how things panned out for him. 😎
  Forum: By Share Code

Dr Wally
Posted on: Nov 1 2018, 01:26 PM


Group: Member
Posts: 344

I checked with n **FDA regulatory expert** on the status of publishing receipt of an RTF. He said the following "Failure to publicly disclose A Refusal to File letter is an SEC violation. ***Not much doubt about it”. ***

Basing my opinion on simple logic and much faith in the FDA and their processes being above board, I also believe that it’s extremely unlikely that a RTF letter has been issued. It would be so incredibly fkng ridiculous, bordering on insanity, for the FDA, after giving Clinuvel the green light for the Scenesse NDA to be submitted, only to swiftly change course and decide there was something inadequate about it. How would it be possible that after working so closely with Clinuvel, for so long, under their “rolling review” process and guidance, they were sloppy enough to let something nasty slip through and were compelled to issue their RTF letter over something less drastic to rectify to issue?. So much for the “FDA bending over backwards to help Clinuvel”. 😑


A couple of posters here have 100% guaranteed that a RTF letter has been given to Clinuvel.🙀 That would mean that Clinuvel management has broken the law attempting to cover up the fact by not publishing the information, risking penalties, more time wasting and putting their integrity on the line, really! That sounds to me like a bit of conspiracy theory tbh. I can see why Mauricinho gets so frustrated when he reads this board. 🤓
  Forum: By Share Code

Dr Wally
Posted on: Oct 25 2018, 01:27 PM


Group: Member
Posts: 344

It is frustrating though that so much precious time has been wasted for no good reason. I’m absolutely positiv that soon after approval is given the very people responsible for these epic delays and uncertainty will be praising the drug for its potential to slash skin cancer rates amongst other things.

They’ve been batting on about the skin cancer epidemic for decades now but ironically they’ve had their boot on the throat, halting the progress of the the one and only product that will solve this problem. It will give the masses what they want and provide them with benign systemic photo protection at the same time.. It’s a win ,win unless your business is flogging sloppy ineffective possibly toxic and actually cancer causing (no UVA protection) sun cream. 😎 That’s a billion dollar industry also with a lot of power and influence. I bet their hoping Scenesse never sees FDA approval.
  Forum: By Share Code

Dr Wally
Posted on: Oct 25 2018, 12:05 PM


Group: Member
Posts: 344


Levelheaded-
“Let me put some things in perspective for those who are having moments of irrationality.”

The fact is, in late 2018, the only ones acting irrationally, when it comes to Scenesse, are the regulators. These Ignoramus’s won’t be able to deny the long list of game changing benefits forever.

1. Safety of Scenesse will overcome regulator irrationality at some point! 😎

This is the essential fact that keeps me calm and sane in times like these. It gives me absolute confidence in my Clinuvel investment.
  Forum: By Share Code

Dr Wally
Posted on: Oct 23 2018, 02:07 PM


Group: Member
Posts: 344

The only thing we have to fear is TIME itself! 😑


  Forum: By Share Code

Dr Wally
Posted on: Oct 23 2018, 01:48 PM


Group: Member
Posts: 344

Drug safety will trump regulator corruption, preconceptions and paternalistic concerns. It will guarantee Scenesses approval at some stage. Absolutely no doubt about it.
  Forum: By Share Code

Dr Wally
Posted on: Oct 23 2018, 12:57 PM


Group: Member
Posts: 344


Yes it’s telling. The frustration and confusion as to why such a safe and effective drug continues to be resisted/shunned by regulators (some even prepared to act corruptly to halt Scenesse progress -NICE- 🤬) leaving it to sit on shelves when it could be providing the long suffering EPP community the ability to escape their current life of darkness, has left everyone speechless.

Should be able to gauge fairly accurately how things are going to pan out for the foreseeable future the next time we hear back from FDA though. Not concerned at all about PR (that should be given but this is the drug that tans the skin after all so it’s progress can never be speed up😑) but if still not satisfied and Clinuvel is asked for more data concerning random seemingly trivial issues then expect a 2020 approval date to be an optimistic outlook as this time wasting game in the hope of uncovering something negative could go on for some time yet.

Hoping to be proven absolutely wrong here. Please god I’m begging you to prove me wrong! 😫

The FDA know explicitly that a positive decision on Scenesse will open the door, be it in 2 years be it in 5 years, to mass Afamelanotide usage. What a massive game changing decision it is. It’s crunch time for this drug, company, EPP community and investors.

GLTA. 🤞🏾
  Forum: By Share Code

Dr Wally
Posted on: Oct 17 2018, 10:44 PM


Group: Member
Posts: 344

“what insights how effective MSH could help with ms” “why is cuv not starting any studies in this field?”

Theyve had plenty of down time whilst waiting for regulators to get their heads around the drug and its wide ranging implications once FDA approved, so you would have to think that they’d (Clinuvel) have just about every angle possible covered by now. Im sure all will be revealed in regards to Afamelanotide and Clinuvel once the FDA barrier is eventually breached.


“Naturally, CLINUVEL’s teams anticipated the possible success of SCENESSE® and through their knowledge and expertise in optical physics and medicine, patients’ behaviour under extreme conditions, the company became global leaders. Our employees focus and specialise on key areas such as:
• the properties of visible light and ultraviolet light
• the interaction of visible light or UV light emitted and human biology in general
• behaviour of skin under extreme conditions
• the effect of hormonal therapies on anti-inflammatory and nervous disorders
• the release of pharmaceutical products in a controlled delivery
At CLINUVEL there is a deep reservoir of expert knowledge beyond the realm of this history and future to the company. We aim to use our knowledge to innovate products for smaller patient populations and larger audiences. In our own laboratories, we use active and non-active ingredients for formulating medicines for smaller patient populations (orphan diseases), while knowledge and derivatives of these medicinal products are tested and used for products benefiting a broader audience. Innovation is far from easy, not only is technology required to be robust over time, new measuring instruments, precision tools, biochemical assays, delivery devices and much education is required to be successful. CLINUVEL specialises in the introduction of novel medicinal technology, skin care products, protection under extreme conditions for all.”
  Forum: By Share Code

Dr Wally
Posted on: Oct 17 2018, 10:03 PM


Group: Member
Posts: 344


“Through learning, research & development CLINUVEL’s teams became the global experts in launching innovative therapies and unhinging established views, success in innovation comes with the complexity and pain of proving novel concepts first, as no other company would have preceded. “

“unhinging established views”

I wonder what those established views are? I wonder if they’ve been unhinged yet? 😑
  Forum: By Share Code

Dr Wally
Posted on: Oct 10 2018, 07:01 PM


Group: Member
Posts: 344

Corruption = “dishonest or fraudulent conduct by those in power”

That’s a fair description of how these time wasting utterly conflicted bureaucrats acted I feel. They’re playing games and it’s pretty obvious.If you suffered from EPP you probably wouldn’t be so forgiving. 😑

You’d have to have a fairly good education to jag a job at nice right?
  Forum: By Share Code

Dr Wally
Posted on: Oct 10 2018, 04:11 PM


Group: Member
Posts: 344


“A ten pct drop whitout news makes doubt spin in many minds.”

The enthusiasm that existed has almost evaporated hasn’t it.
I spose the realisation that PR won’t be happening and senseless FDA resistance likely to drag on for some time yet had a bit to do with it.

“Clinuvel was after bringing a tanning agent to market”

Royco funny thing is they still are. It’s the exact same molecule ☺️ it’s just taking longer than they ever imagined it would for regulators to move forward, get over their tan phobia, update their outdated knowledge in this area and accept the science. Too easy ay.
  Forum: By Share Code

Dr Wally
Posted on: Oct 10 2018, 01:41 PM


Group: Member
Posts: 344


“No further appeal avenue is available under the NICE Appeal Process, however consultees have up to three months to apply to the High Court for judicial review.”

The appeal panel identified clearly that NICE acted unlawfully in a number of ways. Judicial review it is then! 😎
I wonder if NICE will be stubborn enough or stupid enough to force Clinuvel into taking the situation to that level of scrutiny. Their prejudices if not obvious to open eyes now will be hard to dismiss even by the most naive if they go down that route.

i. The failure to include an IPPN representative from the second HST Committee meeting;

ii. The failure to demonstrate adequate consideration of the legal duties and obligations placed on it as a public authority under the Equality Act (2010). The Appeal Panel considered that this is likely to include express consideration of whether the methodology used in the evaluation of SCENESSE® discriminates
against patients with EPP and if so what reasonable adjustments should be made; and

iii. The Appeal Panel’s conclusion that it was unreasonable for the Committee to state that the trial results
***show small benefits with SCENESSE®***


What would possess a powerful governing body like NICE, supposedly with Scientific procedure and data at its core, to behave in such an unethical way, knowing all too well that underestimating (lying about) efficacy of the drug would lead to the denial of the one and only safe and effective treatment that a small and vulnerable group need to be able to live a normal life?

It’s all very well and reasonable to object to the price of a drug if that’s your true concern but corrupt behaviour like this is the product of something that runs way deeper than money.
Nothing that Scenesse drug safety won’t eventually overcome though.
  Forum: By Share Code

Dr Wally
Posted on: Oct 9 2018, 04:46 PM


Group: Member
Posts: 344

Why would they sell now or in six months, even more so why would they sell after achieving the allusive FDA approval? the most important of decisions thats been 20 years in the making, the decision that opens the floodgates to all possibilities and guarantees multiple billions within 3-4 years of FDA approval.
How much would Clinuvel be worth then? All the hard work was done leading up to and gaining FDA approval, post approval it’s time to sit back and let the good times roll.
I’m not having a go at you, it just doesn’t make any sense to me. Selling a few years before approval with lingering doubts of an approval, I could understand that, but not at this late stage with the proven safety profile that Scenesse has and its once in a life time potential to do incredible things.


“Clinuvel has never been one to present at conferences in order to attract investors. In the last month this has changed.”

The way I’ve understood things, the reason why they’ve kept a low profile was simply because they didn’t want to annoy any further the all powerful regulator of drugs and fortunes in the US (FDA). Putting those guys off side even more than they have been over the years was unnecessary but Clinuvel is at the pointy end of proceedings now and like most here they would be totally frustrated with the time squandering delays.

They know their product is bulletproof so it’s time to let the Biotechnology field know all about Scenesse, in the process gaining industry understanding, acceptance and support and putting the approval situation under the spotlight where NICE type decisions should be less likely to occur.
  Forum: By Share Code

Dr Wally
Posted on: Oct 9 2018, 01:25 AM


Group: Member
Posts: 344


“ if someone had an issue with the fact that the product causes the skin to tan, that would have surfaced early on”

Hawaaaaa!!! Please tell me your taking the P1ss rabbitrun? 😱 😱 my mind is a little fragile atm 🤯. Time for bed see you in 2020. 🤖👽
  Forum: By Share Code

Dr Wally
Posted on: Oct 8 2018, 11:31 PM


Group: Member
Posts: 344

What’s your take on this super long, super slow approach taken by the FDA with Scenesse? This unjust drawn out process is volviéndome loco! 🤬🤯👨🏾‍🚀


Another 2010 review found that when used for hair loss finasteride increased rates of sexual problems.[46] A 2016 meta-analysis found that sexual dysfunction, including erectile dysfunction, loss of libido, and reduced ejaculate, may occur in 3.4 to 15.8% of men treated with finasteride or dutasteride.[21] This adverse effect has been linked to lower quality of life and can cause stress in relationships.[47]

Where would we be If Scenesse displayed a side effect profile like this. Shut down for sure.
  Forum: By Share Code

Dr Wally
Posted on: Oct 8 2018, 11:04 PM


Group: Member
Posts: 344

Finasteride- Human trials in 1986 - approved 1992 for BPH - approved for male pattern hair loss in 1997. 5 years later.

“According to the company's 1Q2016 financial filing, Merck is a defendant in 1,385 product liability lawsuits which have been filed by customers alleging they have experienced persistent sexual side effects following cessation of treatment with finasteride.”

The list of destructive side effects of this drug is long and recent studies are a real concern. Most of these effects were realised early on but FDA approval was swift compared to the never ending struggle out completely safe Scenesse is still engaged in. 😑 why are we still waiting??

“The primary outcomes were the prevalence of depressive symptoms and the prevalence of suicidal thoughts as determined by the Beck Depression Inventory II; all subjects self-administered the questionnaire at the time of the interview or up to 10 months later.
Rates of depressive symptoms were significantly higher in the former finasteride users (75%, 46/61) as compared to the controls (10%, 3/29). Moderate or severe depressive symptoms were present in 64% (39/61) of the finasteride group and 0% of the controls. Suicidal thoughts were present in 44% (27/61) of the former finasteride users and in 3% (1/29) of the controls.
Finasteride has been also associated with sexual side effects that may persist despite discontinuation of the medication. In a clinical series, 20% of subjects with male pattern hair loss reported persistent sexual dysfunction for over 6 years, suggesting the possibility that the dysfunction may be permanent. These subjects also reported a wide range of symptoms including changes in cognition, ejaculate quality and genital sensation. “

“Finasteride
Finasteride, a commonly prescribed medication for male pattern hair loss, has been associated with persistent sexual side effects. In addition, depression has also been added when finasteride 1 mg is used. The drug reduces the levels of several neuroactive steroids linked to sexual function and depression. The current study assessed depressive symptoms and suicidal thoughts in former users of finasteride who developed persistent sexual side effects despite the discontinuation of the medication.”
  Forum: By Share Code

Dr Wally
Posted on: Oct 8 2018, 06:16 PM


Group: Member
Posts: 344

Some believe the reason we sit here waiting for a completely safe and effective drug to be approved is primarily because of bad management. I politely disagree.

One Igno rant person here believes it’s because Scenesse is ineffective for some reason and Cimetidine is the future for the EPP community....Hmmmmm, I see.........Your fired!! 😸😸😸

And It seems there’s one person here (me🤓) that believes that If the drug didnt stimulate a **tan** it would have been approved years ago. I know absolutely crazy right.


Does anybody here actually believe that the FDA is absolutely fine with the tanning aspect of Scenesse? and the extended timeframes and BS that has gone on forever and continues still for one of the safest most effective drugs ever is normal, all fine nothing to see here, where on our way to regulatory approval with scientific parameters and regulations being applied equally to Scenesse as was applied to the systemic male hormone blocker that supposedly regrows head hair. Just one example.

Life long daily androgen blocking medication for a TRUE cosmetic condition that if you read up about it the efficacy of the drug is rather thin (pardon the pun) if existent at all.

I wonder how long the approval process for that systemic hormone blocking drug with a long list of serious health effects lasted?

I’m jumping in without much knowledge of the situation but im willing to bet the ultra safe Scenesses drawn out approval time is years longer (with still possible 18months plus to go) than this “propacia”. Finasteride hormone blocking drug.

Regulators inability to get over their irrational tanning fears has cost us years and multipl millions. Fkn over their paternalistic (corr7pt Maybe) slow ass BS ways. 🤬🤬🤬

The side effects of this drug are atrocious but it was approved in less time than Scenesse. (Don’t fact check that just yet) 🤣

Visit My Website <a href="https://www.mensjournal.com/health-fitness/are-hair-loss-drugs-safe-20150914" target="_blank">https://www.mensjournal.com/health-fitness/...s-safe-20150914</a>
———
It’s not really my website.
  Forum: By Share Code

Dr Wally
Posted on: Oct 8 2018, 03:04 PM


Group: Member
Posts: 344

“At best, they have been told no priority and NDA accepted and filled and waiting pdufa.”

100%...... Im praying for it but it’s a certainty (always has been) that Clinuvel won’t be seeing the FDA grant their Priority Review for Scenesse NDA. FDA are going to happily drag this out for as long as they legally can, a la Europea. 2020 sometime will be the best we can hope for (Scenesse approval) I feel, barring a miracle. 🙏🏾

Not having FDA PR granted, is in no way indicative of Scenesses approvability (the one certainty in this never ending journey is that Scenesse WILL eventually be approved) it’s just proof that the regulator deplores the drug because it stimulates a safe, photo protective, therapeutic **tan.**

  Forum: By Share Code

Dr Wally
Posted on: Oct 6 2018, 01:34 AM


Group: Member
Posts: 344

“He said they need to focus on one approval”

Have truer words ever been spoken?

It should be obvious by now that everything good going forward hinges solely on the much anticipated FDA approval. It would make no difference to the big picture whatsoever if Clinuvel were to get Scenesse FDA approved for a sore thumb instead of EPP just so long as its successful in gaining the FDAs approval. Everything else will stem and flow and become reality from that point on.

Thankfully because of Scenesses (Afamelanotides) completely benign nature the second phase of Clinuvel won’t be anything like the slugfest leading up to the approval, also the FDA approval will provide absolute certainty for many investors that continue see Clinuvel, even at this late stage of development, with nine out of ten boxes ticked, too much of a risky investment. FDA approval is gold. 🙂
  Forum: By Share Code

Dr Wally
Posted on: Oct 5 2018, 01:10 PM


Group: Member
Posts: 344

“I am confident the FDA will analyse these data as **a final step before it takes a stance on Priority Review**. Since we are in **frequent contact** with the agency I believe that both parties are working towards the desired clinical outcome for US EPP patients, although at this stage further timelines have not been provided by the FDA,” Dr Wright said.


It’ll be very telling the next time we hear back from the FDA won’t it. Either they’ll be completely satisfied with everything (finally) and expressing it by granting their PR for Scenesse OR there’ll be more time wasting requests for this and that; an unfortunate outcome really that would clearly show their utter reluctance to make the final leg of this drawn out journey any easier or faster.

Scenesse was proven to be incredibly safe a decade ago and continues (4 going on 5 years after European approval) to provide life changing outcomes for more and more EPP sufferers without the slightest of issue. In fact there are a number of substantial issues but they all stem from the apathetic approach regulators have taken over the years to Scenesse, stifling significant progress and access to the needy.

What on earth could US regulators want or need that they havnt clearly seen or been given by now? They must (like everyone else) clearly see the incredible health benefits that a drug which safely and naturally blocks the harmful effects of light, so it must safe to assume that like Dr Wright has stated, this latest lot of data will be “the final step” and we can ALL progress contently and confidently into chapter 2 of the Clinuvel saga. 😎😎😎😎

A long long list of indications (millions) that will safely benefit from the stimulation of natural melanin within the skin. Can you imagine the interest in the media when FDA approval becomes reality?



https://www.asx.com.au/asxpdf/20181005/pdf/...08y4s7t65gw.pdf
  Forum: By Share Code

Dr Wally
Posted on: Oct 4 2018, 09:49 PM


Group: Member
Posts: 344


“Yes you want the implant, you need something systematic. Topicals do not cover enough area and are too hard to apply in all the areas that you need to apply them.”

Clinuvel “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.”

———

“The terms topical and transdermal are often confused, used interchangeably, and poorly understood. This stems from the fact that all medications applied to the skin are topical by definition (applied to the top of the skin). However, the term topical medication generally refers to medications applied to the skin that rely on passive diffusion into the skin itself, creating a local effect. “

“Transdermal medications refer to medications that are applied to the skin but involve skin penetration enhancing compounds or technology that increase the amount of drug that can cross the skin barrier, often to the point that the drug can enter the systemic circulation and exert effects in areas other than the site of application.”


https://genscopharma.com/difference-topical...al-medications/
  Forum: By Share Code

Dr Wally
Posted on: Oct 2 2018, 06:28 PM


Group: Member
Posts: 344


The safety of Scenese is taking them somewhere they thought they were never going to have to go. The land of approval to embrace the demonic drug that tans the skin, Bwahahahaha! 🤑🤑🤑
  Forum: By Share Code

Dr Wally
Posted on: Sep 30 2018, 01:18 PM


Group: Member
Posts: 344

I’d like to hear what the good people that invested in the early 2000s would think about things “just getting started”? 😟
FDA approval is the beginning of a decade at least of strong growth so hopefully the realisation of that will provide a little consolation for the two decade wait. 🙂

No FDA PR will be so disappointing though for numerous reasons. For me, it’ll be the strongest of indications that US regulators are continuing to struggle (even at this late stage in 2018🤬) to get their heads around the game changing drug that stimulates a natural photo protective “tan”. . If PR is rejected you’d have to think that these guys will unashamedly be prepared to drag things out to the bitter end and 2020 could be a real possibility as unpalatable as that sounds.

Alternatively the FDA have accepted that Afamelanotide will provide a multitude of health benefits to millions of people and that trumps an irrational fear of unbridled tanning bringing about the end of the world. 😑 If drug safety is as sacrosanct as I think it is, if logic, common sense and science prevails , Clinuvel will see a PR and approval 6 months after that. That day will be a momentous day even if the market takes a week or so to realise the implications of that decision.
  Forum: By Share Code

Dr Wally
Posted on: Sep 29 2018, 07:29 PM


Group: Member
Posts: 344


“At what point in the future will you look to exit??

Post FDA ?
NASDAQ listing?
otc products?
buy out?
other? “

At what stage to sell some, or all of your stake in a once in a lifetime blockbuster is a very real problem thats sure to create a little anxiety, but it’s one of those rare problems in life that you’d rather have than not.
Finding a sympathetic shoulder to cry on when that time comes will be just as difficult I reckon. 😎
  Forum: By Share Code

Dr Wally
Posted on: Sep 28 2018, 08:58 AM


Group: Member
Posts: 344


Pre FDA approval = Huge amount of uncertainty continues to exist. No matter how good the financials or anything else for Clinuvel seem to be right now the uncertainty concerning the regulators ability to accept and approve a tanning drug (the exact same drug that they flat out rejected in 2004-5) for a small population that they know will eventually be accessed by millions is very real for many. Regulators can’t deny this drug indefinitely though. The safety of Afamelanotide (Scenesse) will force their hand at some stage even if ignorance still exists.

The resistance has gone on for too long. This drug has been in existence for 40 plus years and been scientifically evaluated for 20. Even 12 years of grey market use by hundreds of thousands of people with similar molecule from god knows where (China😮) at ridiculous dosages has caused no real problems.

(Don’t need to hear any BS from any “holier-than-thou” types, thanks. I’m just providing a real life example of the safety). There’s no way I would have invested so much money and time in this if I hadn’t experienced it for myself.

Post FDA approval = Every last speck of uncertainty eliminated. The begging of a decade of incredible growth, the realisation of which will drive the SP to who knows where. Long list of known indications (and more relatively unknown and surely some completely unknown) will become reality within 24 months of US EPP approval because of supreme drug safety. Photo protective application for millions will happen after FDA approval.
A (Afamelanotide) tan is incredibly photo protective and the polar opposite to cosmetic. Think spray tan if talking cosmetic. Once in a lifetime opportunity to get on board still exists.
Whatever the SP is pre FDA approval will be be looked back on as cheap because of the uncertainty that continues to keep many out of this stock.


Anything below 100 post FDA approval is totally ridiculous. 🙂

  Forum: By Share Code

Dr Wally
Posted on: Sep 27 2018, 01:41 PM


Group: Member
Posts: 344

Would be fair to say it’s the only thing keeping the lid on atm??😐


X-RAY $100 would be (edit) reasonable I reckon. 🤓
  Forum: By Share Code

Dr Wally
Posted on: Sep 27 2018, 11:20 AM


Group: Member
Posts: 344

The stock is undervalued though and the next “event” could be announced any day. Sell now at your own financial peril. 😀


I’d love to see a copy of RCs receipt. Just saying.🤣
  Forum: By Share Code

Dr Wally
Posted on: Sep 25 2018, 02:39 PM


Group: Member
Posts: 344

Sellers have evaporated. I wonder why!😎

Things can change in an instant obviously but atm there are less than 7000 shares below $30. It’s great to see.🙂
  Forum: By Share Code

Dr Wally
Posted on: Sep 25 2018, 01:36 PM


Group: Member
Posts: 344



I understand, and usually I wouldn’t be so cocky but this safe and incredibly effective drug has been held down and kept out of reach for far too long and for what? It annoys the sh1t out of me tbh and I’ve only been a holder since 2010.
As certain as I am that the sun will rise tomorrow, in I’m just as certain that Scenesse will (eventually) be approved. How and for what reason can they (in 2018) deny the volumes of positive data?

The key here is simple really. Absolutely no safety concerns. The only unknown is how much longer the FDA is prepared to hold off on signing the paperwork for Scenesse and how much longer they’re prepared to keep the vulnerable EPP community living in the dark. T





IgnoreAnus! Good to see your still lurking brother.🤓 Any thoughts? 😑 Hows the Cimetidine treatment going? Seriously. 😑

  Forum: By Share Code

Dr Wally
Posted on: Sep 25 2018, 12:17 PM


Group: Member
Posts: 344


“Well it isn't the end.......”
😎 😎 😎

Truth be told the Clinuvel machine is only just warming up. FDA approval will knock this beast into the first of many gears that will drive the SP north for another decade at least.

Even though we’re now sitting around $20 for CUV, prospective investors should understand clearly that any price pre FDA acceptance/approval will be seen as a bargain within a few short years.

Priority review or not, (am expecting no PR myself) Scenesse approval is a done deal.




  Forum: By Share Code

Dr Wally
Posted on: Sep 20 2018, 10:16 AM


Group: Member
Posts: 344


I completely understand what your saying but even suggesting that we shouldn’t be discussing something will come across to many that there is something significant to be worried about. That couldn’t be further from the truth.

No matter what happens concerning the highly unlikely RTF letter or the granting of a PR, or not, after decades of nothing but positive data, combined with Scenesses long term categorically accepted safety profile, approval of this incredibly safe, cancer preventative drug (to mention just one area of its game changing application) is 100% assured.

No safety concerns = eventual approval.

As certain as the sun will rise tomorrow you can be just as certain that the FDA will soon acknowledge, accept and embrace the life giving and life saving powers of Afamelanotide (Scenesse) if they havnt already. 🙂

  Forum: By Share Code

Dr Wally
Posted on: Sep 14 2018, 07:23 PM


Group: Member
Posts: 344

Hahaha! Y’all ain’t fooling anyone round here IGGY. 🤣 where you been?
  Forum: By Share Code

Dr Wally
Posted on: Sep 11 2018, 06:15 PM


Group: Member
Posts: 344

That’s true, they must have thought the collateral damage from not keeping investors informed was preferable to putting powerful regulators off side and possibly making the long complicated road to approval even more fraught. Their timelines have always blown out and their promises rarely kept and that’s been super frustrating for a long time but I place the blame Squarely on regulators not management. The drug is extremely controversial and the resistance to it has been unjustifiably long and harsh when you consider how safe and beneficial the drug is.
I could be wrong and Clinuvel management have been treating us with contempt all along for no good reason at all but what would they accomplish by acting that way?
Anyway that cautious, diplomatic, soft approach is about to change I feel.
  Forum: By Share Code

Dr Wally
Posted on: Sep 11 2018, 05:33 PM


Group: Member
Posts: 344


Wally- “We’re too close to the finish/start line now and even semi informed investors in Clinuvel would have to realise this fact. “

Just read back over my post again. It sounds like I was implying that your a semi informed investor in Clinuvel. Nothing could be further from the truth I just get a bit excited at times. Sorry about that Royco.
  Forum: By Share Code

Dr Wally
Posted on: Sep 11 2018, 02:49 PM


Group: Member
Posts: 344


—————

“We are suddenly in the headlights and if we stall, we could end up roadkill too.”

Not one bit possible now Royco. Supreme safety and time spent (decades now) on the process assures Clinuvels approval and incredible success. I know you know this. 🤓

I’m absolutely expecting though, for our progress to be stalled periodically (for trivial reasons) by FDA and I can’t imagine Scenesse getting this PR unless they’ve (FDA) had a recent epiphany that would see them completely embracing the drug that tans the skin and feeling the urge to right past wrongs and speed it through 16 weeks 😑 earlier then via the standard route. Either way it won’t make a speck of difference to the end result that’s fast approaching.

Not expecting SP to drop away like it has done in the past either. We’re too close to the finish/start line now and even semi informed investors in Clinuvel would have to realise this fact. Taking a big risk attempting to sell portions of your stock for minimal gain at this crucial stage of the game. SP raising announcements could be made any day now.

On the subject of RTF letter. I’m sure some in the agency would love to give it but the “rolling review” process has to stand for something (it must) so I can’t imagine Clinuvel having to go through the setback of receiving a RTF especially when safety is not at all an issue. RTF would be a scandalous outrage but It’s simply not going to happen.

Bucket loads of extremely positive news coming from all corners, ramping up in coming weeks/months is just the start of it all. Clinuvel instead of saying little and virtually hiding away from view so as to not annoy already disgruntled regulator are now unambiguously stating that they are in the business of providing systemic photo protection to the masses without EPP mandatorily being mentioned in every sentence. 😎

*** Not taking anything at all away from having Scenesse approved first and foremost for the long suffering EPP community I’m just saying it’s a huge shift in how the Clinuvel mind set has changed and how their now strongly and confidently approaching this final leg, of this part of the journey.
  Forum: By Share Code

Dr Wally
Posted on: Sep 11 2018, 01:38 PM


Group: Member
Posts: 344

1000s of tiny and even single share sells doing a good job at keeping the SP down; for the moment that is.🤐
  Forum: By Share Code

Dr Wally
Posted on: Sep 6 2018, 01:27 PM


Group: Member
Posts: 344

“A drug that receives Fast Track designation is eligible for some or all of the following:
###• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval ###
###• More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers ###
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
• Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) ### for (review by FDA), rather than waiting until every section of the NDA is completed before the entire application can be reviewed. ###

### BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA###

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on

### whether the drug fills an unmet medical need in a serious condition.###

Once a drug receives Fast Track designation, early and ### frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. ###

The frequency of communication assures that

### questions and issues are resolved quickly, ###

often leading to earlier drug approval and access by patients.“
Hmmmmmmm! 😑
  Forum: By Share Code

Dr Wally
Posted on: Sep 6 2018, 12:10 PM


Group: Member
Posts: 344

I’d prefer to have some resolvable issues, that will eventually be sorted out with scientific data and logic, with a stubborn regulator than to have my life savings caught up in a company run by a bunch of incompetent fools that seemingly can’t get an extremely safe drug to market.

That would keep me up at night.
100% confidence with Clinuvel and Scenesse. Even when the set backs like yesterday occur I fear nuclear war more than I worry about my investment in Clinuvel.

  Forum: By Share Code

Dr Wally
Posted on: Sep 6 2018, 11:49 AM


Group: Member
Posts: 344

“ Contrast Clinuvel with AMAG/PTN's NDA submission for bremelanotide which was accepted by the FDA with a standard review and no need for further data. It is a stark comparison since patient experience with brem is so small compared to that with Scenesse. “

How and why would this happen??

Bremelanotide is a cyclic heptapeptide lactam analogue of α-melanocyte-stimulating hormone (α-MSH).[6] It has the amino acid sequence Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH,[7] and is also known as cyclo-[Nle4,Asp5,D-Phe7,Lys10]α-MSH-(4-10). Bremelanotide is an active metabolite of melanotan II that lacks the C-terminal amide group.[8]
Aside from melanotan II and endogenous melanocyte-stimulating hormones like α-MSH, other analogues of bremelanotide include afamelanotide (NDP-α-MSH), modimelanotide, and setmelanotide.


Bremelanotide. Systemically acting peptide hormone = female sexual dysfunction = minimal benefit for extremely small population.
VS
Afamelanotide. = Systemically acting peptide hormone = photo protective tan= a long long list of major health benefits guaranteed to protect and benefit millions by stimulating a natural photo protective tan.

Long list of life changing/saving (skin cancer to mention just one) benefits VS female sexual dysfunction for tiny population on thin evidence.

There’s no doubt in my mind that regulators fear, more akin to a phobia of tanning and sunlight, through ignorance, is what is really behind the longest approval process in history for one of the safest most beneficial drugs in history.

This kind of stalling tactic for trivial reasons (nothing to do with safety) is a sign that their campaign of resistance is in its death throes though. I wasn’t shocked yesterday and I’m not worried today at all about Scenesses prospects.
The only lingering issue that remains is for how much longer will these guys be able to (legally) stall the process by throwing up road blocks like this? It can’t go on indefinitely.

If people are of the opinion that management and not regulator, who’s whole outlook in this area will be turned upside down by approving “the tanning drug” Scenesse, is the reason why we continue to have setbacks in 2018 when we should be -rolling- down the regulatory pathway to approval then sorry, I must live on another planet. The issue is completely clear to me. 100% regulatory resistance based on outdated ideological grounds *and irrational fears.*

You’ll do yourself a massive disservice if you attempt to compare Clinuvel, in any area of the drug approval process, or on the financial side of things with any other drug that’s come before. Scenesse is a game changer of the highest order.

Bremelanotide, cleared for takeoff.

Afamelanotide (Scenesse) stalled once again for seemingly trivial reasons for who knows how long!
  Forum: By Share Code

Dr Wally
Posted on: Sep 5 2018, 04:50 PM


Group: Member
Posts: 344

“But it could in fact be a 23 year old FDA inspector who’s
causing the RTF. “

Haha, it probably is too. He/she🙂is probably buying the dodgy bootleg melanotan from China and selling it online and making a fortune. Cheeky little #&@t!! 😼


Can I ask a favour? Do you mind if I use your all too true statements below as my post signature.


-Rolling review is not a rolling review.
Fast track is not fast.
Priority review says nothing about approvability.

But also:

A RTF is not catastrophic!-

  Forum: By Share Code

Dr Wally
Posted on: Sep 5 2018, 04:03 PM


Group: Member
Posts: 344

If you want to keep your sanity as a shareholder in the company thats producing one of most controversial drugs ever; Scenesse; I believe you have to realise two things:

1- The majority of western regulators would like nothing more than to see this drug fail. They are unashamedly prepared to stall its progression whenever possible and by whatever means, dragging the process out no end, in the hope that some negative data will show up somewhere and they can pull down the shutters once and for all.

Their decades old completely unbalanced ideology where sunlight is toxic and a tan is a certain death sentence is the real reason behind their never ending resistance. That twisted view of reality is slowly but surely being flipped on its head. Just like when they supported the fat free diet and the industry the was created off of the back of their support. Change is always slow in coming and strongly held outdated beliefs can take an eternity to shift. Case in point.


2- The safety profile of Scenesse (Afamelanotide) is (gold) A1 . It is totally benign and actually beneficial in a number of ways. The safety aspect could not be any better and we are so lucky to have that. So so lucky😎. Success is built off of the back of safety and Scenesse has proven herself beyond doubt and is no longer a concern even to the FDA.

I wouldn’t dare call the remaining Ignoramus’s in the agency stupid but by pulling this kind of BS move today it wouldn’t be far from the truth in calling them an extremely stubborn bunch of rotten old bureaucrats would it!

Science, facts and truth will force their ignorant ass’s into embracing and approving Scenesse. The show rolls on! 😆 Get it? rolling review. 😐😑

———
## Anything to say about today’s news IGGY? You must be busting at the seems.##
  Forum: By Share Code

Dr Wally
Posted on: Sep 5 2018, 09:58 AM


Group: Member
Posts: 344


Buyers
No. Quantity Price
1 250 15.800
1 85 15.770
1 494 15.750
1 1 15.180
1 2000 15.150
1 1000 15.100
1 86 15.040
2 496 15.000
1 140 14.900
1 197 14.810
——————-
Sellers
Price Quantity No.
14.800 2702 4
15.020 1113 2
15.110 50 1
15.150 2266 2
15.250 100 1
15.300 1000 1
15.340 600 1
15.400 6000 2
15.500 1000 1
15.600 1500 2
  Forum: By Share Code

Dr Wally
Posted on: Sep 4 2018, 03:40 PM


Group: Member
Posts: 344

Of course, that’s true, but the “rolling review” process where you lodge sections as you go makes things a bit weird/ambiguous at this stage of the process when the waiting time for a yay or nay decision is exactly the same as for the standard review were nothing at the time of lodging has been evaluated by the FDA and there has been no or possibly minimal regulatory guidance.

NDA is logically only submitted once every section leading up to the completed brief are deemed unambiguously sufficient, yes? It would be ridiculous to attempt to move forward with the NDA if the preceding module/section was lacking crucial data that could even remotely present a problem.

Following a logical progression, a drugs approval is only a matter of time from the NDA lodgement date when dealing with a RR surely?

If Scenesse wasn’t subjected to the benefits and insights of the “rolling review “ process all bets would be off and I would be back in the 1% chance camp. (Edit 50/50 camp)🤓

Would you not think the “rolling review” process was a complete sham and a total waste of time and effort if Scenesse was to be rejected?


“Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA”
  Forum: By Share Code

Dr Wally
Posted on: Sep 4 2018, 12:01 PM


Group: Member
Posts: 344

I’ve conversed at length over the years with friends, family and others about Clinuvel. For numerous reasons, even at this late stage of the journey, there still exists a considerable amount of uncertainty concerning Scenesse (the tanning/barbie/melanotan drug) and its chances of being completely accepted by Western regulators.

“Markets hate uncertainty”.

A Priority Review being granted would eliminate any remaining uncertainty or lingering doubt from the minds of 99% of these potential investors. The remaining 1% are beyond help and are going to have fun attempting to board the Clinuvel bus once “officially” FDA approved. Good luck seeing through the clouds of tyre smoke IGGY!!😸

As discussed previously, PR being granted must be seen as a virtual pre approval, approval. Knowing that Scenesse approval is certain only the paperwork won’t be officially signed off on for 6 months seems to me to be a crazy situation. Here’s a mulitibillion dollar company in its infancy, its game changing, first in class product totally de risked, only thing lacking the FDAs signatures on the dotted line (which is assured) in 24ish weeks. If that isn’t the absolute definition of “price sensitive” document I’d like to know what is. 🤓

A decision (either way) is expected this week but is it possible that decision won’t ever become public knowledge?? Does Clinuvel have to legally disclose this information?


Sorry Waz that question wasn’t meant to be specifically aimed at you. 🙂
  Forum: By Share Code

Dr Wally
Posted on: Sep 4 2018, 12:35 AM


Group: Member
Posts: 344

“10-15 years”😉

Ok, I see what you did there!

The (now so obvious) irony went straight over my head. I completely misunderstood the nature of your post. Only took me three read overs to realise you were taking the p1ss. 🤣

Lucky I’ve got a few Clinuvel shares to fall back on...... seriously. 😑


What about the timing there. 12:35 - 12:35. Amaysim! 😎
  Forum: By Share Code

Dr Wally
Posted on: Sep 3 2018, 04:46 PM


Group: Member
Posts: 344

On a serious note.

“Fastforward 10-15 years....

Photo protection/antioxidant/DNA repair "supplement" : 500USD”

## “Also, new indication for approved drug should be smoother/faster with existing safety and pharmacokinetics data in place.” ##

10-15 years is a lifetime. After 20 years of thorough successful development for EPP with supreme safety why would it take that long? The same molecule only difference being how it enters the body, via a transdermal patch or cream vs the original implant.

Average drug development time is said to be 12 years. I realise your probably down playing things but I’ll be shocked and extremely disappointed if Clinuvel doesn’t have the photo protective angle covered within 2-3 years of FDA EPP approval.

They’re always scaring people about the negative effects of sunlight. Clinuvel has the answer.
  Forum: By Share Code

Dr Wally
Posted on: Sep 3 2018, 10:57 AM


Group: Member
Posts: 344

(10:55:25 AM 15.000 225 ASX)

Yes!!😎 17.500 today would be nice. I can almost smell it🤣.

Call me a fool, I don’t care, i bought CUV at 0.150. (Pre consol).

Seriously though good luck to all holders of Clinuvel. A wholesome company with incredible potential. 🙂

Priority Review or not! Clinuvel will make its mark.
  Forum: By Share Code

Dr Wally
Posted on: Sep 3 2018, 10:39 AM


Group: Member
Posts: 344

Seriously!!! 14.990!!! one freakin cent to bust into the 15s, cmon market you can do it!! 😆

NewtoCli “2021 .... or by end of 2018?”

2021? I mentioned 2020 not so long ago and was told it was surely a “bad joke”. I spose wll find out sometime this week won’t we. 😑
  Forum: By Share Code

Dr Wally
Posted on: Sep 2 2018, 12:19 AM


Group: Member
Posts: 344

Possibly 😶 one of the most exciting weeks in Clinuvels history coming up next week. Could go close to nipping $20 with expectations high on gaining FDA Priority Review. The spotlight is turning Clinuvels way for a long list of solid reasons and after decades of blood, sweat and tears the end game (and the beginning of chapter 2) is well and truely in sight.

If PR is granted, Clinuvels name will be flowing from everyone’s lips and the games will really begin. A PR would provide absolute certainty that FDA approval is guaranteed along with the shorter and more precise timeframe (6 months to lift off) while SR could blow out 12-18 months or longer. The news of such a positive event (PR) would have to push the SP into the high 20s, 30s.

Submitting the Scenesse NDA after having the FDAs “Rolling Review” process, that provided personal guidance over the years is no guarantee that Clinuvel will get their PR next week but it has to be seen as proof that everything the FDA would ever want or need to sign off on the approval of Scenesse has been included in the long awaited document.

In MHO approval is a certainty either way but If the FDA were to give their PR and then NOT approve Scenesse it would have to go down as one the most ridiculous decisions of all time. Doing that would absolutely destroy their credibility. It would be the height of inefficient bureaucracy and the Biotechnology industry would loose all faith in the agency.

Add to all this Scenesses (trump card) exceptional long term (proven beyond doubt) safety profile and there’s a zero chance that the FDA approval won’t be given at some stage even if PR is not.


What’s the chances of the FDA granting their PR next week IGGY?? 😸
  Forum: By Share Code

Dr Wally
Posted on: Aug 31 2018, 12:59 PM


Group: Member
Posts: 344


WTH is going on out there! Are people expecting some exciting, long awaited, price sensitive news next week or something! 🤓
  Forum: By Share Code

Dr Wally
Posted on: Aug 23 2018, 11:29 AM


Group: Member
Posts: 344

That would make a hell of a lot more sense and definitely restore confidence in management. A solid company with a super drug like Scenesse (Afamelanotide) with endless potential, bringing out some junk cosmetic product into a market flooded with crappy products already seemed like a strange and desperate move. I thought it must have been brought on through the frustration of dealing with the likes of NICE and others. If correct it really is great news.
  Forum: By Share Code

Dr Wally
Posted on: Aug 14 2018, 09:59 PM


Group: Member
Posts: 344


You must have meant to say: Why WOULDNT a tanning drug get FDA priority review?

Long term safety, life giving, life saving qualities. Give me one sensible reason why FDA shouldn’t give this incredible therapeutic drug their Priority Review.
  Forum: By Share Code

Dr Wally
Posted on: Aug 10 2018, 08:50 AM


Group: Member
Posts: 344

When I’ve taken a look I’ve seen thousands of tiny little trades constantly and consistently being made throughout the day from 1 through 5 - 20 - 56 or slightly more. Check it out for yourself. You can see a human trade when it comes through say for 1200 or more as they really stand out. And then the constant micro trades that constantly drive the price downward and occasionally I’ve noticed 1 - 5 - 20 ish shares traded that have taken the SP higher. Hoping to freak out the humans and drive the SP either way buying and selling at the perfect time. Is it the same entity manipulating things? IGGY maybe? Could this be the churn X-ray speaks of?

$50- 80 - 100 profits being made throughout the trading day sitting on yr ass hardly raising a sweat would add up to a decent little earn by the end of the week. Need to get me one of those little algo robots! 🤖
  Forum: By Share Code

Dr Wally
Posted on: Aug 7 2018, 12:14 PM


Group: Member
Posts: 344

And what an extraordinarily huge offer it would have to be considering the potential of Clinuvel 12-24 months post FDA approval. 🤑
  Forum: By Share Code

Dr Wally
Posted on: Aug 6 2018, 08:14 PM


Group: Member
Posts: 344

“Seems fair enough to me; why should a drug maker be able to name their own price without any questions regarding the drug’s effectiveness from those who pay the bill. “


The only doubts that remain about Scenesse efficacy reside in the twisted minds of the few remaining Ignoramus’s. You know like that bozo Dr Peter Jackson. Guys like that have (for whatever reason) hidden agendas. Logic and reality of the situation don’t come into the equation for them but sadly it effects thousands of innocent vulnerable people like those with EPP and similar diseases and also frustrates the sh1t out of investors that have put their hand earned into a safe and wholesome product that could have and should have been approved and widely used, years ago. 😡
  Forum: By Share Code

Dr Wally
Posted on: Aug 6 2018, 02:43 PM


Group: Member
Posts: 344

“In addition, they questioned the NICE committy rather critically on aspects raised in the appeals, for example on the validity to use a generic Quality of Life measure, which knowingly, and I want to stress knowingly here, underestimates the positive effects of the treatment instead of the proposed EPP specific Quality of Life instrument, which is significantly more appropriate. “

What would make highly educated, powerful, medical professionals 😑 act in such a dumb and clearly biased way? NICE are fundamentally opposed to Scenesse and it should be obvious to everyone by now.
The summary of the appeal leaves no doubt that these guys have no shame and are prepared to say or do anything to prevent Scenesse (Afamelanotide) from becoming reality in the UK. Their dislike runs way deeper than the cost of the treatment.

“Dr Peter Jackson, the chair of the NICE committee, stated that EPP does not qualify as a disability because disabilities would be visible…”

Contender for the most idiotic statement made by someone that should/does absolutely know better. This unempathetic dinosaur doesn’t deserve to keep his medical license.
Let’s hope there are no Ignoramus’s like this inside the FDA residing over the ALL important Scenesse NDA.
  Forum: By Share Code

Dr Wally
Posted on: Aug 1 2018, 02:35 PM


Group: Member
Posts: 344

FDA- “There is no such thing as a safe tan. The increase in skin pigment, called melanin, which causes the tan color change in your skin is a sign of damage.”


FDA capitulation and approval of Scenesse will vaporise the ever lingering and substantial doubt that many potential investors in this stock are concerned about; that being that the most powerful and influential of regulators would more than likely NEVER be accepting or appreciative of a drug that seemingly goes directly against western governments 40 plus year rhetoric and dire warnings about sunlight and skin tanning. Ironically (Scenesse) Afamelanotide would achieve everything that these health agencies over the past 40 plus years with their scare campaigns and billions of dollars spent demonising sunlight have spectacularly failed to achieve.

Long term safety has been proven and the obvious health benefits are unparalleled with many more to be revealed after FDA acceptance. Scenesse approval opens the door for the mass use of Afamelanotide to provide systemic photo protection to millions of vulnerable people around the world and this is the real reason behind the regulatory go slow I believe. They don’t want it but the safety is now overwhelming, the photo protective health benefits are absolutely undeniable and the APF and public pressure is building. It’s simply a matter of when not if but I get the feeling some dinosaurs within aren’t prepared to roll over just yet.

When Scenesse is eventually FDA approved there’ll no doubt be massive interest from the media and the information snowball effect will begin. The truth will finally be revealed to the world (no more need for Clinuvel to withhold information about the reality of their product) and this enigmatic company with the much maligned drug that’s been spoken of for decades but never materialising will come to life. If 30 dollars isn’t achieved within a week of FDA approval then I’ll @#$& €$@#+ %&@. 🤓

FDA approval of Scenesse is just the beginning of something special. Is there anything that could compare to the market potential of a super safe 99.9% efficient photo protective (skin cancer preventative) with huge cosmetic appeal and a multitude of therapeutic effects. The rush for this stock will be legendary once that final but overwhelming FDA risk factor has been neutralised.
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Dr Wally
Posted on: Aug 1 2018, 02:34 PM


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Obviously you didn’t read through the whole article.😑
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Dr Wally
Posted on: Jul 28 2018, 10:27 PM


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Posts: 344

“and why is he mentioning fda can take up to 24 months?”

From what I understand of this standard or priority review program BS the 6 month or ten month timeframe is “a goal”, the absolute best case scenario for nice little non controversial drugs that tick all the boxes but for ground breaking, game changing, massively controversial drugs like Scenesse (that safely tan the skin and prevent skin cancer, flying in the face of their 5 decade old rhetoric) that 6 month timeframe can simply blow out for whatever reason they feel warrants it.
“Clinuvel 2020” is the cryptic clue that says to me that this is the year Clinuvel expects to gain FDA approval for Scenesse.
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Dr Wally
Posted on: Jul 19 2018, 02:13 PM


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Posts: 344



Oh sh1t!! Do you think we’ll see $10 anytime soon Nostradamus? Im ready for more but am thinking therell be a few more bargains to be had if not granted FDA priority review.
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Dr Wally
Posted on: Jul 17 2018, 05:06 PM


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Posts: 344

Best of luck to these guys on Monday 30 July 2018. The small vulnerable EPP community shouldn’t have to beg like this for a life changing and completely safe treatment. They should have had their suffering alleviated years ago. I get the feeling though that theres no chance that the dinosaurs at NICE will be accepting Scenesse until after the FDA find it in their hearts to do so. Who knows when that will be? 😑

FDA approval, public pressure and the fact the the drug is completely safe will be the forces behind them eventually having to accepting it. I don’t believe for 1 minute that pricing is behind their disgraceful denial of the facts.
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Dr Wally
Posted on: Jun 26 2018, 01:00 PM


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Posts: 344

Word on the street for the last 4 decades or so is “there’s no such thing as a safe tan”.

IgnoreAnus might be able to enlighten us on this subject maybe??🤓
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Dr Wally
Posted on: Jun 20 2018, 02:05 PM


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Wholly SH1t!! 😮😮😮 I wasn’t expecting that.
I’m not looking in the mirror again till I hear that Scenesse has been approved in the USA.
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Dr Wally
Posted on: Jun 20 2018, 01:46 PM


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Posts: 344

-“Verharven’s post of a couple days ago now has a tally of 432 views. The dog and pony show on this board doesn’t seem to be working? What do ya reckon Dr Wally?”-

So who are you IGGY? The dog or the troll, ooops sorry I meant to say pony,Seriously🤣.

Your the ONLY one attempting (for god knows what reason) to twist the facts here. Everyone else is in total agreement about scenesse, it’s safety, effectiveness and incredibly bright future. I feel the only issue where there might be some disagreement would be on the subject of whom to blame for the length of time it’s taken to get this benign drug approved; inept management OR ignorant, stubborn ego driven regulators.

Scenesse is LONG TERM proven, PERIOD!
Your idiotic support of toxic Cimetidine and constant bashing of Scenesse is proof to all that lurk on this board that your just trolling and can’t be trusted.


-“The CUV share price is whatever the manipulators want it to be at any given moment. “-

Your right IGGY but It’s been that way for many years now as you know and will continue until FDA capitulation, acceptance and eventual approval of Scenesse. I’m pretty sure you realise this also but you love to troll so good for you mate.

-“Totally meaningless trading as it could snap up to $13 or down to $9.00 without any news; good or bad. “-

SEE ABOVE!
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Dr Wally
Posted on: Jun 18 2018, 12:23 PM


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Posts: 344

🤖
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Dr Wally
Posted on: Jun 18 2018, 12:23 PM


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Posts: 344


“Whoever thinks Clinuvel will meet the deadline replies
with a YES.”


It’s not something I’d be bragging about but as certain as I am of this drug one day being accepted by western regulators and changing the lives of millions and making billions/year I’m just as certain that July 1st will be pushed back with the high probability of further unjustified and ignorance based delays to provide further opportunities to buy in cheap.

That’ll be a big fat frustrated NO from me. Would love so much to be proven wrong though.
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Dr Wally
Posted on: Jun 18 2018, 11:57 AM


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Posts: 344

Yeah cool. I didn’t think there would have been that many but it goes to show how many people come here to get information on Clinuvel, and even though it annoys regulars, why it’s worth spending a few minutes shutting down Ignore anus’s ridiculous lies and flimsy deceptions. Go IGGY!!🤓
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Dr Wally
Posted on: Jun 12 2018, 01:39 PM


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Posts: 344

“ The drug is out of patent long ago.”

You don’t say. Scenesse is only called Scenesse because of the way that Afamelanotide is administered into the body. That being a dissolvable implant.
Dissolvable Afamelanotide implant = Scenesse. It seems your Ignoramus in name and nature.😸

I don’t know squat really about MNP technology, I only bought it up because I couldn’t recall seeing anything about it here but from what I’ve read it seems that very recent developments are enabling peptide size molecules to be successfully delivered via this route so could be slightly relevant, no!

Ive been under the impression for many years now that the transdermal cream was going to be the holy grail and never looked for or heard of another viable option for systemic Afamelanotide delivery. Stumbling across one that could now be way more efficient and effective, one that would allow many millions of susceptible people to benefit from the potent benefits of Afamelanotide, first and foremost for UVR protection, without the invasive procedure that accompanies the implant, was extremely exciting but slightly concerning at the same time.

SURELY Clinuvel has this angle covered though right? They’ve had plenty of downtime to not let anything as important as this escape their grasp and after all they are the leading experts in this field. Does anyone have any information or know anything about this possible scenario? Tia.

I post my opinions and thoughts hoping to spark a discussion so that maybe I/we all might learn something. Knowledge is power. I’ve no idea what your about with your ignorant statements but who cares really, you’ve proven yourself to be a constant deceiver for many years now. Some might say a incompetent shyster hey IGGY.🤣
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Dr Wally
Posted on: Jun 10 2018, 02:12 PM


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Posts: 344


“Topical competition?”

Forget about topical for serious mass market UV protection, Clinuvel could shock the world very soon and bypass that avenue altogether with the announcement of an Afamelanotide infused transdermal (microneedle) patch. Set and forget to realise all the benefits of the implant without any of the drama involved. Obviously this wouldn’t be spoken of till approval was given for Scenesse but who would know with these guys.

-“Microneedle (MN) arrays are minimally-invasive devices that are used to penetrate the skin’s outermost layer, the stratum corneum (SC), which is the principal barrier to topically-applied drugs”-

https://www.sciencedirect.com/science/artic...378517317300923

https://www.sciencedirect.com/science/artic...141813017332178

Not at all invasive like the implant with it’s minor surgical procedure needed for insertion. Most importantly the MNP is guaranteed to stimulate melanin as accurately and as potently as the Scenesse implant itself. Looking into MNP over the w-end i now understand why the cream would have to be labeled a “cosmetic”. Maybe this is the reason why we havnt heard much on the topical/transdermal cream front of late?

A minimally evasive, easily applied, super effective skin patch would be a massive leap forward and for obvious reasons would supersede the topical/transdermal cream even before its release. Having to apply cream everyday would be hit and miss at best and in terms of reaching the optimal levels of Afamelanotide needed to stimulate bulletproof amounts of melanin, like that of the implant, the cream simply couldn’t compete.

The drug (Afamelanotide) has proven itself beyond doubt so could a micro needle patch, instead of a cosmetic cream, for easily applied implant matching UV protection be on the cards in the not too distant future for the masses? The technology for peptide delivery seems to be available and advancements are happening every day so it’s only a matter of time till it’s announced by someone. It just better be Clinuvel!!!


-“Transdermal delivery of therapeutic biomolecules (including peptides) can avoid enzymatic digestion that occurs in the oral route. (Polyethylene glycol) diacrylate (PEGDA)‐based microneedles, with good biocompatibility, are easily fabricated through photo‐polymerization with a precisely controlled structure. It has successfully been used for the transdermal delivery of small molecule drugs such as 5‐fluorouracil. However, the delivery of peptide‐based therapeutics using this platform is seldom reported. This is because of the potential damage to the peptide during the photo‐polymerization process of PEGDA. Herein, we introduce a method to load PEGDA microneedles with peptides without compromising peptide potency.

Microneedles are emerging as a proficient transdermal delivery system. It allows a variety of molecules to be transported into skin in a minimally invasive way, which overcomes the limitations of conventional needle injection.1-3 Polymer‐based microneedles are specifically attractive due to their excellent biocompatibility, biodegradability, and nontoxicity”-


https://onlinelibrary.wiley.com/doi/full/10.1002/btm2.10070
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Dr Wally
Posted on: Jun 5 2018, 09:34 PM


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Posts: 344

“So some lucky guy could conceivably win money from Johnny and have his bowels release on you.

This needs to be videoed “

WOW!!! 😵 “some lucky guy”. What the hell are you hinting at Seeva222?
This would have to go down as the single most disturbing post in CUV SS history, surely!
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Dr Wally
Posted on: May 29 2018, 11:11 PM


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Posts: 344


“Who.The hell.Writes an.Article with two.Lines.Per paragraph.”


-Giles Delaney is an experienced business journalist, having worked for newspapers and magazines in the Asia Pacific for more than three decades. As a guest writer, Delaney retains full editorial freedom and his views are his own. Delaney is happy to answer readers’ questions via mail@clinuvel.com. Answers will be posted on the CLINUVEL website.-

You should email the guy and ask him what his go is seeing’s he’s so “happy” to answer readers questions. Might explain as to what inspired this paragraph riddled (and in the spirit of Clinuvel communiques) rather ambiguous article in the first place.
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Dr Wally
Posted on: May 29 2018, 12:56 PM


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Posts: 344

I had a slight feeling that the post may have been slightly tongue in cheek but it seems that you missed the point of my reply.

Please God! When will the FDA finally put us out of our misery? 😆🤣😂
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Dr Wally
Posted on: May 29 2018, 11:38 AM


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Posts: 344


Wholly crap!! 😮That’s a bit OTT isn’t it? Reality Check, through his own actions, could be called many things but worse than Hitler? 😶
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Dr Wally
Posted on: May 28 2018, 05:55 PM


Group: Member
Posts: 344

#cimetidinehttps://www.drugs.com/sfx/cimetidine-side-effects.html"]#cimetidine[/url]
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Dr Wally
Posted on: May 26 2018, 01:45 AM


Group: Member
Posts: 344

Yes i know. I feel like a massive d1ckhead, I advised DoktorBen just the other day that Igno was a shyster but I didn’t think he would come out and state something as ridiculous and easy to refute as this. I didn’t think he would be that stupid. Yes I know Cimetidine. Ok I’m an idiot. 😑

Anyways It’s the perfect example for anyone new here to plainly see that Ignoramus has absolutely no credibility, will say anything, and is completely corrupt for reasons unknown.

There was a rumour that he sold his lot when he should have held so is now a jaded soul, the Clinuvel ghost in “no side effects” spandex.🤓

Thanks for the clarification Farma. I was actually hoping that this fake news story was going to turn out to be true. Oh well.
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Dr Wally
Posted on: May 25 2018, 10:58 PM


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Posts: 344



“The UK were in the Scenesse trials program and were willing to pay approx. $US7,000 per implant.”

Is this fake news? If this statement is true then I’m a victim of my own ignoramus but would be extremely happy about it to be honest. Would be absolute proof that NICE are NOT totally against Scenesse and that Clinuvel management did make a huge error in not accepting that price.

Thanks to anyone that can shine a little light on this subject for me. Don’t know how I missed this.
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Dr Wally
Posted on: May 25 2018, 10:21 PM


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Posts: 344

“Woman wearing this sun protective clothing is a common sight in Asia. I wore similar clothing on my recent trip to the Philippines.” Ignoramus.

Haha your a classic Iggy! The majestic sight of you in a spandex burkini, scooting around the back streets of Bohol on a Smokey old moped would strike fear into the local children and bring tears to the eyes of SS forum regulars.

Could be an awesome way to promote your “side effect free” photo protective/lifestyle range of island wear.

Ignowear! The first and last word in form fitting idiocy. ph34r.gif
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Dr Wally
Posted on: May 24 2018, 09:34 PM


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Posts: 344



“What is your fair price for the drug?”

Who cares what Iggy thinks is a fair price for Scenesse? For some strange reason he belittles the (proven beyond a shadow of drought) profound benefits of Scenesse and spruiks the non benefits of ridiculous drugs like Cimetidine for EPP instead. You are dealing with a shyster here DoktorBen. Save your breath.

Asking NICE on the other hand what they believe is a fair price for the implant could clear up much confusion and speculation. I’m of the opinion that NICE are simply being deceptive by using the price as a throw off when really they are dead set against this drug no matter what Clinuvel wanted to charge for it.

This battle with resistant regulators just goes on and on and is doing nothing but waste our precious time and money, not to mention keeping a completely vulnerable group of people living a life in the dark and shadows from accessing a completely safe drug that will enable them to live and enjoy their lives in the sunlight. Not for minutes but for hours. They have actually been begging these ignorant bureaucrats for a number of years now for access. It’s a fking joke.

We need to know, right fking now, what would they pay for this ground breaking treatment? If they won’t disclose to Clinuvel, a price that they would find acceptable, then that would say to me clearly that the real reason behind their resistance is ideological and not financial.
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Dr Wally
Posted on: May 14 2018, 10:10 AM


Group: Member
Posts: 344

“Make no mistake Iggy sure as shit has Clinuvel shares. “

Hopefully he’s got something. The poor old fella was spruiking the benefits of “Cimetidine” over Afamelanotide a few months back so he might not be lying.


Hahaha! Great minds think alike! 🤓


FDA priorityreviewvoucher

everything-you-need-to-know-about-fda’s-priority-review-vouchers
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Dr Wally
Posted on: May 12 2018, 11:13 AM


Group: Member
Posts: 344



“SS members hold close to as many if not more than the 3rd to 8th biggest insto holders”

Is this accurate or just a guess? How did you find this out?



FDA Priority Review Voucher
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Dr Wally
Posted on: May 12 2018, 01:58 AM


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Posts: 344



Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs
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Dr Wally
Posted on: May 12 2018, 01:38 AM


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Posts: 344



https://www.sciencedirect.com/science/article/pii/S2452302X1600036X

FDAs approval process clearly explained from start to finish. Old news for most around here obviously but people new to Clinuvel should get something from it.

“FDAs mission includes ensuring that new medical treatments reach the public as quickly as possible while simultaneously ensuring that new treatments are both safe and effective.”

Tick and tick! Might be a smooth ride through the NDA process after all. 😊

The NDA
The NDA (38) includes all data concerning the drug; all information about the manufacturing process and facilities, quality control, and assurance; a complete product description (chemical formula, specifications, pharmacodynamics, and pharmacokinetics); indications; labeling; and proposed risk evaluation and mitigation processes if applicable. A typical NDA can run 100,000 pages, and according to the Office of the Federal Register, the application fee in 2016 for an NDA that requires clinical data is $2,374,200 (39,40). The FDA has 60 days to determine if they will file the application once it is received (41).

FDA reviewers will evaluate clinical data, analyze drug samples, inspect the production facilities, and check proposed labeling. The Federal Food, Drug, and Cosmetics Act requires that there be “substantial evidence” of drug safety and efficacy (42). The FDA interprets this as needing at least 2 adequate and well-controlled Phase III trials with convincing evidence of effectiveness (29), although this is not a guarantee of approval. The FDA often convenes advisory panels of experts to review the data, and usually follows panel recommendations. Approval may include specific conditions, such as requirements for post-approval (Phase IV) clinical studies, distribution restrictions, changes to labeling, or other requirements.

FDA review occurs within 180 days of receipt of a complete application (38). An accelerated process is available for generic drugs, products that provide “meaningful therapeutic benefit” over existing drugs, those that concern serious or life-threatening conditions, or those that address a previously unmet medical need. If the application is found to have deficiencies, the clock stops on review while the manufacturer is given an opportunity to respond to the deficiencies or withdraw the application. If approval of the NDA is denied, the FDA sends a complete response letter describing specific deficiencies and recommending ways for the applicant to make the application viable. Unsuccessful applicants may request a hearing.
Upon review and approval of the NDA, the manufacturer is free to manufacture and market the drug. A summary of the timeline, costs, and overall probability of success for the drug development process can be found in Figure 1 (12,41).
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Dr Wally
Posted on: May 11 2018, 03:14 PM


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Posts: 344



This “skin and body care” OTC product is intriguing. I’m sure most here are hoping that this doesn’t turn out to be a complete fizzer and a decision that they’ll/we’ll regret. Maybe Pier Walnut has lost his mind after all these years of banging his head up against this now moronic regulatory brick wall that just goes on and on and on. Maybe he hasn’t! 😑

Trransdermal Afamelanotide (“Scenesse Topical?”someone wrote the other day) bit hard to rub an implant into your skin but I get it) has been mentioned a couple of times now. It would have to be seen as a complete genius of a move if Clinuvel were able to sneak their “holy grail” topical/transdermal Afamelanotide out into a multi millions (conservative) of sales/year market after struggling for decades (still struggling) to gain acceptance by the overwhelming majority of regulators for the implant version that is only going to be available to around 10 thousand patients. How this could even be possible? It seems like such a ludicrous idea. Would be a complete blow out if it was somehow accomplished.

Might they have bypassed the FDA altogether and possibly negotiated some kind of deal in one of the many Asian countries/jurisdictions where pharmaceutical regulations aren’t as thorough or as strict or even non existent? What would the point of doing this though if they were going to have issues getting that product back and onto the shelves in the US or any other county that has a regulatory agency and process? That idea doesn’t seem at all feasible.

On the other hand what would be the point of bringing some garbage run of the mill moisturising cream out in the US or anywhere else for that matter unless you have lost hope in bringing your no1 product to market anytime soon and you just want to be seen as though your actually creating some kind of value by getting something, anything into the market place instead of sitting around for another couple of years doing nothing other than praying for approval.

The impression I get though from many here is that management are completely stupid and inept so this product launch will probably confirm this to be true and create a sh1t load of worrying questions surrounding the future of this company or conversely it will be a legendary move that will restore much needed faith and blast the SP into the stratosphere quicker than those pencil neck bureaucrats at the FDA can erect another set of time wasting regulatory road blocks to beat our hard earned gains down into single figures once again.

Please god let something positive come from this “skin and body care” launch! 😟

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Dr Wally
Posted on: May 10 2018, 01:25 PM


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Posts: 344



“IF Scenesse is not approved by the FDA on completion of the NDA process in late 2018 early 2019, it is confirmation to me that there are some truly dark powers that work behind closed doors. “

It’s not at all about unknown “dark powers”, maybe if they get their hands on an implant or two when they eventually wake up and come to their senses, then yes, they could be considered to be “dark powers” couldn’t they 😉 but after the many years wasted through regulator resistance, based on outdated and unbalanced science that considers sunlight to be some kind of poisonous evil force, not to mention the millions of dollars that’s been squandered because of their incredibly paternalistic bs, I simply see them as a bunch of ignorant, unempathetic, idealistic, outdated, overly bureaucratic, slow to react, time wasting #@&$.

This company should have had 5 successful years up it sleeves by now and EPP sufferers and shareholders living the good life but because of their ignorance we have a bunch of competition breathing down our necks, riding off of the company’s pioneering research and hard work instead.

When you consider some of the poisons that they’ve approved over the decades, to keep this incredibly safe and effective drug down and out for so long is criminal. Long term safety has been proven long ago and anyone that questions efficacy is blatantly playing games or has some kind of corrupt agenda. Times up FDA!!
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Dr Wally
Posted on: May 7 2018, 06:56 PM


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Posts: 344

Its still here you just haven’t realised who it is and what it calls itself yet. Same style just slightly less obnoxious as it doesn’t bat on about plants or its other delusions. Sorry about the term “it“ but I have no idea if it’s male or female or transgender so I’m playing it safe in this overly sensitive PC environment.

On another possibly negative note. I have no doubts that one day Scenesse will gain the all important FDA approval at some point in time. How could they not support it given it’s benign nature, cancer preventative properties and host of other amazing health benefits that are only just beginning to be understood but I’m not convinced that these guys (FDA) are ready to roll over just yet and give up their 4 decade long war on sunlight.

I’m preparing myself for a European style farce with US regulators unashamedly wasting our precious time simply because of their long standing ignorance in this space. If they do deny again it will obviously be bad for the SP, god only knows how low it could go if they were to remain ignorant and illogical but you could look at it as just another great buying opportunity on this long winding road to understanding, acceptance and ground breaking approval.
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Dr Wally
Posted on: May 1 2018, 11:43 PM


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Posts: 344


“Vallaurix 4 years of R&D didn’t create much value? Wonder if the results of the vitiligo study will ever see the light of day. Been a long time waiting. “

Getting FDA approval for EPP is the ONLY thing that matters. I wouldn’t worry too much Iggy, everything else will fall into place real fast once this happens. You’ll see some real value created on that day and for many years to come.

Sell that old moped and buy a few shares.
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Dr Wally
Posted on: Apr 28 2018, 10:47 AM


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Posts: 344



“When will the announcement come? Soon, I have a feeling.”

WTF! Please! Next thing you’ll be saying you can “smell” $20 already.

Erodes any good work you do here.
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Dr Wally
Posted on: Apr 24 2018, 03:23 PM


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Posts: 344

Haha! So dodgy.
How’s yr moped going?
Also is that Egore dude related to you or what Iggy? He seems like a nice enough guy. 😑
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Dr Wally
Posted on: Apr 24 2018, 02:48 PM


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Posts: 344

I pray daily to the regulatory gods that the all powerful FDA have well and truely gotten over their tan phobia. Surely the overwhelming, positive, long term safety and efficacy data that has been well established has evolved their thinking and allayed all of their fears and concerns.

You would have to think that if theyve managed to move forward in a logical manner then their “priority review” will be granted at some stage. That decision would have to be the strongest of indications that their resistance has completely abated and their golden tick of approval is virtually assured. It will be incredible if that decision is publicly announced though you would have to think. Does it have to be announced by law?

Surely they wouldn’t foolishly hand out their PR “voucher” if they hadn’t fully accepted the science, acknowledged the plethora of health benefits that this drug will bring to society and have fully come to grips with their “tanning” conundrum that has unjustly held this company down for so long, would they?

If they did and then turned the drug down it would have to be seen as a completely treacherous and disingenuous thing to do and proof that many more illogical and irrational games were coming our way similar to the games played in Europe since the EMAs shambolic and limp wristed joke of a positive decision going on 5 years now.

They can play games with efficacy data but only a ignoreannus fool would try and deny the truth concerning efficacy because we all know clearly why P values were a little lacking and always will be with a drug like Scenesse. At the end of the day safety is king and thats the main reason why Ive kept my faith with this company and its this A1 safety that will see this drugs approval at some stage. How much longer can they continue to deny, a better than extremely safe, cancer fighting drug like this??
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Dr Wally
Posted on: Apr 3 2018, 11:54 PM


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Posts: 344



Some thoughts from Jim Mellon that I heard tonight that has obvious relevance to our company.

ABC Australia, The Business.
“British billionaire investor Jim Mellon agrees the worst is yet to come for the worlds biggest tech companies but he believes biotech stocks will survive the carnage as investors look for technology that will provide a public good.”

“Using technology in a way that benefits mankind.”

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Dr Wally
Posted on: Mar 23 2018, 02:44 PM


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Posts: 344

“If we are still above 10AUD by next week and it does not sell off, then I will say things are looking good. “

I don’t believe sitting above or below 10AUD next week will be an indication of anything other than the fact that games will continue to be played by some to make some very small gains after another spike for no specific reason.

It’s a pretty safe bet to say it will continue to go on like this (even more so with the speculation of this skin care range) up until the very day the undeniable, long term scientific data pushes the FDA into reevaluating the way they view sunlight, photo protection and skin tanning. The realisation of the benefits (if they don’t explicitly understand already) to society will force them into approving this brilliant, SAFE and life changing drug that the entire EPP community are desperately seeking.

FDAs golden approval will be the only action that will give the market the ultimate certainty it’s been waiting for for so long and that will finally see SP blast off to god only knows where. That should put an end to the see sawing for a while you would think.

I wonder what no fast track will do to the price though? Now that will be a solid indicator of where the FDA are at and how things will likely play out over the next year or two of this seemingly never ending journey I believe, not the manipulated sp.
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Dr Wally
Posted on: Feb 7 2018, 09:20 PM


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Posts: 344

The words fast track any where near the word Clinuvel make me angry for some reason.🤬

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Dr Wally
Posted on: Jan 31 2018, 01:54 PM


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Posts: 344

The only thing left to speculate when it comes to this ledgendary pharmaceutical saga is, for how much longer will regulators resist this safe, effective and simply beneficial drug?

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Dr Wally
Posted on: Jan 31 2018, 01:24 PM


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Posts: 344



“if that happens all the pieces to the puzzle will align thereafter. “

What do you mean “if”??😺
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Dr Wally
Posted on: Jan 11 2018, 02:23 PM


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Posts: 344



“PW expected to stay till 2021 (persuaded at what price?). “


If these guys can manage to get Scenesse approved by the all powerful FDA at some stage over the next 12-24 months, executive compensation will be the last thing we will be thinking about I reckon.


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Dr Wally
Posted on: Dec 3 2017, 02:20 PM


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Posts: 344

http://www.sharescene.com/index.php?act=at...st&id=48888



Hey don’t be blaming me, The Honourable Pier Walnut, for the longest, slowest, most ridiculous, drawn out, road blocked, fast track, priority review of a completely safe and effective orphan designated drug in the history of pharmaceuticals EVER.
I must say though that were closer than ever to being granted a semi, pre-approval, approval (with a number of special (completely reasonable of course) conditions and for the safety of the community a “black box” warning thrown in because you can’t be to sure these days can you) in the good ole US of A, ok guys!!

Just quietly I lay the blame for the somewhat stagnant relationship between Clinuvel and regulators squarely at the feet of “Stan the man” for obvious reasons as you will now see. Here on slide 47, which somehow got left out of our AGM presentation, we see Stan the man in action for the 1073rd time (we’ve had him under surveillance for some time now) since we disassociated ourselves from that lowdown fake suntanning company Epistan or whatever it was called back then. The dumbass keeps cutting the phone line (slide 47) every time I try to call FDA to tell them that if they would simply approve Scenesse for the beloved and tiny EPP community wll stop our research into the cream that nobody would want anyway. Stan has guaranteed me that I shouldn’t be worrying myself or the FDA for that matter as our new formulation doesn’t tan the skin in anyway, only in a fake tan (cosmetic) kind of way if you know what I mean, hint hint nudge nudge! Love your work Stanley.

Just so that I could never be accused of not communique ing with our respected SHs I’ll let you guys in on a tightly held company secret. After polishing off the last of the bottles of “Domaine Leroy Musigny” (that the previous CEO Wayneo had left behind in the Clinuvel cellars with a little note attached “not to be opened till 2010”) one night a few years ago with my old friend Florian ummmm...... Hancock, we decided to call the “cosmetic” cream EPICTAN!! but on second thoughts we decided to go with Chevere cream or something like that.. It seemed way more appropriate seeing’s we have absolutely nothing to do with anything that, could involve, will involve, should involve, does involve or at any time after FDA approval of the first Melanocortin might involve, any Afamelanotide based tanning contraptions, peptides, creams, cheveres, injections, bio chips or Clinuvel branded lines of clothing or broad rimmed hats as we’ve moved right away from that overly hyped and toxic section of the market. No money to be made in that space I’m afraid.

If the truth were told I feel kind of bad for just having a tanned complexion and being CEO of Clinuvel. My psychologist agrees that it sends the wrong message to the regulators and community. If only we could come up with an MSH that regulators would approve of and get behind, maybe ( y-MSH, gamma - melanocyte smashing hormone)? Guaranteed to be no tanning of the skin, whatsoever. Winner!!
I’ll give Elon a call when our phone line is back in action and see if he can do a 100 day or it’s free kind of thing. More on this in the coming weeks!

Oh sh1t!..... Did I forget to mention at the AGM that we could be getting 12 weeks, or another way of looking at it, a glacier cracking 84 whole days taken off of the decades long struggle for acceptance of our safe and effective little drug Scenesse?? Well it really could happen and before 2020 I might add. Just don’t hold your breath ok all you lovely little EPPers and shareholders out there. If there’s one thing we here at Clinuvel have realised over the decades of research and testing; its that it’s way cooler in the shade anyway.



CLINUVEL would like to thank all of its Board of Directors (accept for Stan) just kidding) worldwide staff and once loyal shareholders past and present and we really love and appreciate all of the hard working folks at our most favourite regulatory agency in the whole wide world! ❤️ You know who you are!
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Dr Wally
Posted on: Nov 30 2017, 09:28 AM


Group: Member
Posts: 344


“Naturally big derma don"t want chivere.(or scenesse)
ever
eu dermatology is big in..especially

.France
a developed eu country, rich, with epp trials and no scenesse for their patients in 2017 while ema approved in 2014. “


With totally unwarranted resistance (40 years or so of positive research) coming from professionals (big derma) that obviously know how beneficial to the health of ones skin, completely safe, life changing (for EPPers) and potentially life saving to a huge section of society this prophylactic drug is, what chance does Clinuvel stand?

I get the feeling that the glacial progress of this drug and company has very little to do with management. I’ll be the first to agree that their timelines and projections to milestones and success have been proven time and again to be absolutely worthless but they have been running into a brick wall now for many many years.

Regulators realise the outcome of Scenesse approval in the states and its only going to happen with fundamental change in their thinking and approach to the negatives and positives of sunlight. The “carcinogenicity waiver” gave me hope that things were going to change but it seems like they’re still content to drag this out in the hope it will somehow go away.

Isn’t the FDA full of dermatologist? “big derma”?
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Dr Wally
Posted on: Nov 27 2017, 09:31 AM


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Posts: 344


If you could post an update I’d really appreciate it, cheers mate.
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Dr Wally
Posted on: Nov 27 2017, 09:23 AM


Group: Member
Posts: 344

I hear there’s something going down tomorrow!😎

2018 is fast approaching and after decades in the wilderness sh1t is about to get real, real fast, even if regs continue to drag things out. Safety is king!

How are things going to unfold at the AGM? Will management at this late stage of development continue being vague, cryptic and ambiguous in their ways in the hope they don’t create any unnecessary hype that could annoy the regulatory gods even further OR will there be a change of mindset this year producing a bullish approach to things brought on by years of frustration that their proven cancer preventative drug (to mention just one aspect) has been wasting away in bureaucratic limbo land for no good reason costing the company millions, the drugs supreme safety/efficacy or the realisation that years of appeasement hasn’t helped or sped up the process at all?

My ANZ trading app is undergoing maintenance atm but when I checked the goings on a few hours ago it looked as though there was very little available below $10..... I like! 🤠

I realise it’s the old run up on no news around AGM time scenario but I get the feeling (seems logical) that even though FDA green light could be well over 12months away?? there will be little drift back (if any) like we have seen in the past. Market radars would have to be picking up on this incredible opportunity blipping away right now!
Hold tight and GLTA.
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Dr Wally
Posted on: Nov 26 2017, 11:04 AM


Group: Member
Posts: 344



Hahaha, sounds fair enough but without character limitations easily gotten around. 🤣
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Dr Wally
Posted on: Nov 25 2017, 01:31 PM


Group: Member
Posts: 344



“May I suggest that the board migrates to iHub.”

Seems a little dramatic. It’s not that difficult to just scroll past posts or posters that you don’t like is it? Lot of history here at SS.
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Dr Wally
Posted on: Nov 21 2017, 11:14 PM


Group: Member
Posts: 344



If I could share my opinion on the so called “priority review.” If It’s given it would have to be seen as an extremely positive event. Not because of the massive 16 weeks knocked off of the wait but because it would surely be an extremely strong indication that their resistance to Scenesse could be coming to an end and maybe sooner that some (me) might think. If not given then prepare for an EMA/insurer style circuse to play out for who knows how long.
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Dr Wally
Posted on: Nov 21 2017, 02:31 PM


Group: Member
Posts: 344

“Same situation as CUV with a lot more clarity in SPL's communication.”

The only difference (and it’s a massive difference) being that the FDA doesn’t hold fundamental objections to their drugs existence. It’s going to be a massive about face for these guys to finally accept and approve Scenesse knowing precisely where that decision will lead but I can’t see how (long term safety together with a long suffering EPP community with no other viable options) they can possibly continue to resist the facts or deny the benefits. Logic must and will prevail here at some point in the not too distant future.

Once they get over their illegitimate concerns they’ll realise that this potent skin cancer preventative Afamelanotide will accomplish so much more in this space than their ineffective “sunscare campaign” ever could achieve and they’ll swiftly become advocates for it. There are no logical reasons why they shouldn’t or couldn’t get behind it. Why should the tanning of ones skin for health benefits be looked down on?
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Dr Wally
Posted on: Nov 17 2017, 06:07 PM


Group: Member
Posts: 344


To have 16 weeks taken off of the wait with a so called “priority review” (longest approval process in history for one of the safest most effective drugs) would be an insult after all the years wasted waiting for ignorant overly paternalistic bureaucrats to sign off on this safe and vital drug.
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Dr Wally
Posted on: Nov 17 2017, 08:28 AM


Group: Member
Posts: 344

After all the years waiting and stressing dealing with bureaucratic regulatory ignorance, having achieved supreme long term safety that will force an approval from these stubborn c@nts at some stage and with the finish/starting (approval finish, profit start) line in sight WHY would the majority of shareholders go for a takeover for 30 40 50 dollars when hundreds are a very real possibility maybe 18-24 months away.

Could a takeover occur sub $50? If so why now?
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Dr Wally
Posted on: Nov 16 2017, 02:59 AM


Group: Member
Posts: 344

“Just imagine what might happen to interest levels if management ever start actually promoting the company themselves.”

Sh1t would get real the very moment they did that but management have kept their cards extremely close to their chest for many many years now for very specific and understandable reasons. Even with the low key, kowtow approach they continue to be treated as though they are trying to have poison passed as medicine. So frustrating!
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Dr Wally
Posted on: Nov 10 2017, 01:19 PM


Group: Member
Posts: 344


"Berlin, Chemnitz and Düs- seldorf are the only treatment centers for EPP sufferers and only a small number of about 25 patients are treated there. This is far too little in around 400 known cases of illness, "criticizes Heike Schmitt.

So far, those affected only have the opportunity to apply for one of the few treatment places and to take part in the annual lottery, explains Heike Schmitt from painful experience and adds hopefully: " Maybe someday we will be rewarded for our efforts and finally enjoy the sun. The drug is already available”.
—\x00—\x00

The unfortunate symbiosis that exists between European regulators (that have always been against Afamelanotide because of their (now outdated) position on sunlight and irrational fear of what the approval of Scenesse will unleash on the world) and unscrupulous insurers is a formidable combination that is unashamedly showing no sign that they might be prepared to re evaluate their illogical position and blockading of this safe and effective drug as is shown once again in this recent German article.

Of more importance though is the machinations going on in the US of late. EVERYTHING hinges on a positive FDA decision. I feel that if (when) the FDA tick of approval is given (sometime in the not too distant future) it would go a long way in clearing out the stubborn, ignorant and unjust resistance that remains in Europe. FDA holding back this golden approval gives much weight to lingering European concerns and hesitation.

Worryingly, US regulators have held the same fears surrounding Afamelanotide usage (2004) BUT you would really hope that 14 years later with scientific proof of long term safety, life changing efficacy not to mention all the positive attributes and stunning lack of negatives that they’ll give up on the old rhetoric at some stage soon and embrace the many benefits of this wonder drug. I can’t see how these bureaucrats in 2018 can legitimately continue to deny its existence and benefits.

If logic doesn’t see us through SAFETY sure will.
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Dr Wally
Posted on: Oct 8 2017, 12:43 AM


Group: Member
Posts: 344



In Internet slang, a troll (/ˈtroʊl/, /ˈtrɒl/) is a person who sows discord on the Internet by (attempting to) start quarrels or (attempting to) upset people, by posting inflammatory,[1] extraneous, or off-topic messages in an online community (such as a newsgroup, forum, chat room, or blog) with the intent of provoking readers into an emotional response[2] or of otherwise disrupting normal, on-topic discussion,[3] often for the troll's amusement.
Wikipedia.
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Dr Wally
Posted on: Oct 6 2017, 08:51 PM


Group: Member
Posts: 344


Wow, thanks for that IG......... Why the f@ck did you think I'd be interested in this messed up mumma? I hate big norks! 👨🏿‍🚀
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Dr Wally
Posted on: Sep 28 2017, 01:56 AM


Group: Member
Posts: 344


"Within 48 months we will probably be able to say that no european or US EPP patients will need to suffer any longer and all can live a quasi normal life. (and mrs Lyons can finally retire :-) "

Seriously that has to be Clinuvels 2020 vision.
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Dr Wally
Posted on: Sep 24 2017, 10:44 PM


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Posts: 344

4:30am post - "no capacity in German hospitals, bureaucracy is very big problem"

8:04PM post - "great support from the German government representatives (positive influence on the German health insurance funds) for a faster distribution and treatment with Scenesse"


This is extremely positive news the best I've heard in some time. Thank you for sharing it. 🙂
Just to clarify, was there acknowledgement of issues in the past with government bureaucracy that had been stifling progress? then at some stage of the same meeting talk that something significant has forced bureaucratic change and the resistance to Scenesse (in Germany at least) is finally fading?
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Dr Wally
Posted on: Sep 21 2017, 10:38 PM


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Posts: 344


Hey endymion96 good to see your still about. 🍌 👍🏾 Are you still in contact with Scott from melanotan.org by any chance?
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Dr Wally
Posted on: Sep 20 2017, 11:30 PM


Group: Member
Posts: 344

FDAs ironic conundrum and the inevitable paradox.

The all powerful regulatory agency (FDA) that has for decades stated unwaveringly and categorically that "there is no such thing as a safe tan" deciding the future of a drug that literally stimulates a completely safe, photo protective tan that will (off the back of supreme safety and EPP community testimony) eventually be used by millions.
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Dr Wally
Posted on: Sep 14 2017, 07:06 PM


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Posts: 344

"Much as I'd like to be able to agree with you, I don't think it'll be that simple"

Has anything ever been straight forward or simple concerning this company?


"but NICE, AWMSG, SMC etc. are all their own beasts, and don't care much what the FDA says."

They might be but to say they "don't care" what the worlds leading regulatory agency says or does concerning a drug that they themselves are literally in the process of scrutinising and possibly approving, couldn't be right could it? Why would they deny, reject or NOT take into account extremely solid and reputable data from (gold standard) FDA? If negative data turned up it would be swooped on and progress would be halted so why would FDA acceptance not be used to help clear up any lingering doubts?

Even if European regulators "don't care" or pay no attention to a positive FDA decision it would be used to great effect by advocacy groups when lobbying government agencies thats for sure. EMA approved, FDA approved, what really is the concern or problem here NICE! Please explain! Lingering doubts about US approval surely are a large part of the problem in Europe. It provides a solid argument and goes a long way to support and justify the denial of Scenesse.

The regulators and insurers in a lot of countries would like to see the back of this drug so whilst ever the US hold out on this critical decision they have a justified reason to stall and refuse access. It's only an opinion but I truely believe that any remaining resistance will fade way soon after US approval. The drug is super safe. The only concern now is how long the FDA will drag the remainder of this process out for. Hopefully 21st century act will change some attitudes and speed things up.
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Dr Wally
Posted on: Sep 14 2017, 01:22 PM


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Posts: 344

"You cannot ignore the determined resistance to the Scenesse roll-out in the EU. "

Sure, It cannot be ignored but it's simply a consequence of the drawn out approval process and uncertainty of US decision. As soon as FDA approves Scenesse the European regulatory and insurer resistance in the concerned countries will completely evaporate.
Everything hinges on US decision.
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Dr Wally
Posted on: Sep 13 2017, 10:40 PM


Group: Member
Posts: 344


Yes I have to admit it's possible but on what grounds could they legitimately deny this drug now that long term safety has been completely proven and so efficacious that it is literally giving a new lease of life to sufferers of EPP.

It would be an absolutely outrageous decision if US regulators were to shun Scenesse at such an advanced stage of development and in the face of so much positive data. The EPP community is crying out for this treatment with a lucky few going to extremes to attain it. That people would travel to the other side of the planet to be treated speaks volumes. These guys have been left in the dark for too long now for no good reason. Safety, logic and empathy will trump old irrational tanning fears for sure.
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Dr Wally
Posted on: Sep 13 2017, 08:24 PM


Group: Member
Posts: 344



"After FDA approval, Clinuvel will no longer have to fear being crushed under the regulatory boot. The biggest threat to the company will be long gone and in the past. Clinuvel can finally put the hype machine into full gear and start selling its pipeline to investors too."



SPOT ON! It will be an exceptional day for the EPP community when the FDA accept the fact that there really IS such a thing as a SAFE tan. Will be a pretty decent day for shareholders too I reckon. 👱🏾👍🏾
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Dr Wally
Posted on: Aug 29 2017, 08:56 AM


Group: Member
Posts: 344



"Here clinuvel is sitting on a super antioxidant and can't get mainstream coverage even if they bought it. "

Are they looking for it? I was under the impression that Clinuvels approach (at least for the previous decade) was to keep any substantial information to an absolute minimum even for shareholders in an attempt to keep sensationalism of the product to a bare minimum so as to not annoy the almighty regulators for whatever reason.

If they wanted media attention it could be organised in an instant with a product like this so I'm a little confused about this situation like many others it seems.

What is the consensus on why Clinuvel has kept out of the media spotlight for so long?

Once FDA approved how will these overlords be able to prevent the massive public interest in this drug?



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Dr Wally
Posted on: Aug 27 2017, 07:22 PM


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Posts: 344

Scenesse (implant) is definitely and specifically designed for the devastating condition EPP. No one else.

Everyone else (for many other conditions or reasons) will be able to attain the benefits of Afamelanotide via a transdermal patch or cream.
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Dr Wally
Posted on: Aug 27 2017, 05:22 PM


Group: Member
Posts: 344

The enigmatic tanning drug that never materialised. After 3 plus decades I reckon there would be millions around the world that would strongly relate to your story.

Once FDA approved id love to hear Clinuvel managements take on why such a safe and effective drug was held down and kept away from the general public for so long. I'm sure the regulators have a long list of completely legitimate and reasonable reasons for doing so.
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