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Dr Wally
Posted on: Aug 15 2019, 10:01 AM


Group: Member
Posts: 427


“arzneggs” German for -ignorant, progress delaying regulator-
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Dr Wally
Posted on: Aug 6 2019, 12:55 PM


Group: Member
Posts: 427

It’s been an extraordinarily long and unjust road for all involved in getting this extraordinary drug to this stage of development but the rewards that will come a few years post FDA approval; incredible cancer preventative photo protection for millions (non implant- patch or cream or??) and the huge financial reward for investors will be well worth the wait.

The benign yet powerful Scenesse is going to change the world is an extremely positive way. Once the media get the true story out (after FDA approval) that lies behind the years of disinformation the public will loose their collective sh1t over this beneficial drug. And why shouldn’t they get excited? The world has been crying out for an effective (SAFE) way to protect their skin from sunlight overexposure for many many decades now. 👍🏽


Billy “waiting just on 20 bloody years,” is the absolute definition of patience.
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Dr Wally
Posted on: Aug 5 2019, 10:24 PM


Group: Member
Posts: 427

Biased demonising pseudoscience example from PADs post link from the other day.

“What is tanning?
Melanin is a dark pigment that is produced by melanocytes in the skin and gives natural colour to skin. After exposure to
***damaging sunlight *** (TOTALLY UNBALANCED BIASED VIEW ON LIFE GIVING SUNLIGHT) melanocytes in your skin produce more melanin to protect your skin from UV radiation. This makes the skin look tanned.
A tan is a sign of your skin being exposed to ****damaging UV radiation.***** (NO MENTION OF OVEREXPOSURE JUST “EXPOSED”) It’s your skin's way of trying to protect itself from further damage, so tanning is very far from being healthy.”

UVR is analogous to water. Would it be intelligent to describe water as being dangerous or damaging.
——-
Here is an example of the hysteria that is ingrained even in the minds of professional people.
Can you believe in 2019 a qualified dermatologist would rather subject her young children with their sensitive young skin to proven endocrine disrupting chemicals (suncream) and cover them completely from head to toe preventing any chance of endogenous vit D production that is critical in preventing many life threatening and debilitating diseases like cancer and autism to name just two instead of allowing them to benefit from a common sense balanced dose of natural life giving disease preventing sunlight. Freaking insane.

“As the mother of two active young kids I love UV protective clothing for its ease of use. My routine for our children is to apply a layer of ***SPF 50+ sunscreen then dress them in high necked, long-sleeved UV suits with protective sun hats with a large brim *** to shade their delicate faces and chests. We also tend to hit the beach at ***5pm.***”

🤯🤯🤯 Seriously! 🤯🤯🤯

This is the definition of sunlight hysteria that just won’t go away. I believe it’s this outdated mentality (ideology) is the primary reason why this brilliant cancer preventative drug has been resisted and treated unfairly for decades now.
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Dr Wally
Posted on: Aug 5 2019, 02:04 PM


Group: Member
Posts: 427


It’s been said here before a few times already: Only FDA Scenesse approval will end the decades long uncertainty that these shorters have thrived upon, causing confusion and enabling them to turn a profit from negativity.

They’ll be minimal negativity surrounding Clinuvel once that big fat stinking monkey is off of the company’s back. The strongest of possible growth (not potential growth but real long awaited company GROWTH) for a good decade post decision should put an end to all this shorting and related BS yes? 🥳🥳
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Dr Wally
Posted on: Aug 5 2019, 01:37 PM


Group: Member
Posts: 427

But only 8 weeks out and down over 30% (ath) you would have to be extremely confident to be shorting right now yes?. How can they be so dam confident?

Hopefully these shorters are doubtful of the drug itself. That kind of ignorance will 100% skew their judgment of Clinuvels future and see them ultimately looooose! 😎
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Dr Wally
Posted on: Aug 5 2019, 01:26 PM


Group: Member
Posts: 427

SP on the slide at this point in time instead of rising strongly in anticipation of a positive FDA decision for Scenesse in October (approx 8 weeks) would have to be seen as a fairly strong indication that many are sensing, some even hoping for (shorters), a negative outcome?

I’ve been understanding of management keeping the hype to a minimum in regards to Scenesse in the past as the fundamentals were proven and been well known to investors for years but not communicating in detail about the external issue/s that destroyed the US rollout of Scenesse for this US summer and that are feeding into the already high levels of uncertainty is slightly disconcerting. I might be looking at the situation wrong though? Wouldn’t be the first time.😐

Obviously we appreciate the frustration of the situation at hand but if the issues are easily rectified over the latest 3 month delay period it wouldnt be asking too much to have these issues clearly explained to us long suffering investors, would it? The sharing of That kind of information publicly would be allowed wouldn’t it? Would definitely ease the rising uncertainty and allow many edgy minds to relax.
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Dr Wally
Posted on: Aug 5 2019, 12:26 AM


Group: Member
Posts: 427


“Wouldn’t guess that the stock will be at this level in October... “

I’m praying to four different gods that it will not be 🙏🏽. . If the good people within the FDA that hold our financial futures in their hands decide another delay is somehow justified for Scenesse in October I’m 100% certain my head will explode with utter frustration and furious anger. 💀💀
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Dr Wally
Posted on: Aug 4 2019, 05:01 PM


Group: Member
Posts: 427


Just another example of professional ignorance in this space. No wonder the general public is so confused and at times hysterical about this drug, sunlight, skin tanning, photo protection, UVR, skin cancers and NMskin cancer. Unbalanced and outdated scientific ideology (beliefs) and government rhetoric paid for by sunscreen industry money have been behind the glacial progress and straight up hatred (by many) of Scenesse (Afamelanotide). Should see an enlightenment of some sort in this space after October. 😎

For professionals to continue to prescribe Sunlight abstinence; proven to be extremely damaging and dangerous to your health; to promote Toxic, ineffective, Vit D blocking, UVA wavelength penetrating, sloppy, environmentally damaging chemical suncreams is the definition of ignorance bordering insanity. 😑
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Dr Wally
Posted on: Aug 1 2019, 09:11 PM


Group: Member
Posts: 427

Sorry that I’ve attempted to reassure potential investors that have visited here over the years to gain a basic insight into this enigmatic company with the undisputed fundamentals that literally mean everything. I don’t trade or short this company like some here so I have no need to influence the SP in a negative manner. Yes just two simple facts from me: safety and efficacy and an opinion that management are on top of things considering the sunlight demonising regulatory environment they’ve been stuck dealing with for decades now. Big changes in this space Scenesse will bring. 🥳🥳

Doesn’t matter what countries in Europe that are creeping ever so slowly towards being able to treat their tiny populations of EPP patients (as good and positive as that obviously is), the most important aspect of this drug is it’s exemplary safety record (long term proven): efficacy, as incredible as it is even comes in second to it. This is what forces the hand of the FDA and in turn guides and reassures regulators world wide; without this stellar safety Clinuvel, EPP community and all the investors would be absolutely F ed! Look at the resistance and all the BS that Clinuvel has suffered from regulators over the years even though the drug is better than safe with its therapeutic aspect. Can’t deny this safe drug forever can they!

You don’t seem to get it though. Funny how the only two absolute truths about this company’s drug you fail to grasp the importance of. Sorry I couldn’t come up with some fake news story like you managed to pull out of your a$$ the other day. That was gold Mac. 🤣🤣🤯

I’ll go back and join the gang and thank you for that one.
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Dr Wally
Posted on: Aug 1 2019, 09:31 AM


Group: Member
Posts: 427

I don’t understand why anybody would believe anything this narcissistic day trader of Clinuvel says. Claiming that he/she “donated a larger than usual amount to the APF”, 😝pleeeease! contacting and attempting to influence via PM and ridiculing in the forum when it turned out they had NO idea and were completely WRONG about the RTF says everything you need to know about their personality and overall integrity and understanding of Clinuvels situation.

The company’s management are performing well under these unfortunate circumstances. The drug is incredibly safe and super effective at preventing the damaging and deadly effects of overexposure to UVR. The safety will eventually trump regulator ignorance and disinclination and become one of the most successful drugs ever produced. This is all i need to know. Hopefully the second stage of the journey can begin in October.
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Dr Wally
Posted on: Jul 30 2019, 01:14 PM


Group: Member
Posts: 427

If the FDA capitulate in October .... obviously 100% yes. If they decide to delay for whatever flimsy reason they can muster up again then who knows. The priority review gave me so much hope but this latest 3 month (shut down scenesse for another US summer BS delay after being so closely involved with the company’s NDA for years) has really annoyed me and set my thinking back somewhat that the FDA had accepted the science and data and had moved forward with a modern outlook in this space

Billions of dollars will flow out of one market and into another over a few short years once Scenesse is FDA approved and that kind of coin has some serious gravity. Big $$$ are always going to have some kind of pull but in 2019 and after multiple decades of drug safety and efficacy and millions of eyes watching over the final stages of this glacial journey surely Clinuvel will get the crowning break they deserve: the one that will change everything forever and we can all move forward positively into sunny days.

I can’t accept that another delay (failure) in October is even an option. 😑



#has_there_ever_been_such_a_safe_and_effective_and _beneficial_drug_held_down_and_out_for_so_long_because_of_ignorance_or_corruptio
n_before?
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Dr Wally
Posted on: Jul 24 2019, 04:45 PM


Group: Member
Posts: 427

I wouldn’t go as far as to describe (some) of the past 24hrs postings as dire; ludicrous would be more apt. 😑
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Dr Wally
Posted on: Jul 15 2019, 02:32 PM


Group: Member
Posts: 427

It’s possible that once the FDA give in to the decades of positive data, EPP community pressure and straight up logic of the situation, multiple indications for Scenesse might see a green light in quick succession. Slight justice maybe for all the years wasted.

Once FDA approved for EPP, in depth information concerning Scenesse (the hype) that’s been kept to a minimum for over a decade, will freely flow and the reality of the drug (multiple health benefits and no safety concerns) will spread around the planet like a wild fire and communities will demand access to this utterly safe and effective photo protectant.

The FDA have accelerated the approval of all kinds of drugs and Viagra is proof that the drug doesn’t have to treat a serious or life threatening condition. With a safety profile second to none, why couldn’t/shouldn’t Scenesse be approved within a couple of years for multiple indications for the benefit of millions just like “Sildenafil” was in 1998?
—-

“”Sildenafil, the chemical name for Viagra, is an artificial compound that was originally synthesized and studied to treat hypertension (high blood pressure) and angina pectoris (a form of cardiovascular disease).

Chemists at the Pfizer pharmaceutical company found, however, that while the drug had little effect on angina, it could induce penile erections, typically within 30 to 60 minutes. Seeing the economic opportunity in such a biochemical effect, Pfizer decided to market the drug for impotence.

Sildenafil was patented in 1996, and a mere ****two years later–a stunningly short time compared to other drugs****–it was approved by the FDA for use in treating “erectile dysfunction,” the new clinical name for impotence.””
——
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Dr Wally
Posted on: Jul 14 2019, 02:18 PM


Group: Member
Posts: 427

“AFAICT, once the labeling requirements are communicated, ****it's a done deal, and approval is imminent.”****

“AFAICT” 😬....... Thank god for that! At first glance I thought i was reading something different and we were having another Clinuvel “fake news” FACT graciously laid before us once again as happened with the recent “RTF” letter fiasco. That non event that was guaranteed by a recently new member (Nov 2017) whom it’s said “literally has the FDA contacting him” created (strategically maybe?) much confusion and concern for many.

I checked my IM just in case I was lucky enough to receive a personal explanation (slightly intimidating I might add because of their significance) on the situation once again but sadly there was nothing there. 😭

From what your saying it seems like you couldn’t possibly loose or waste much of your coin if you were to invest the moment we hear from the FDA about the labelling requirements?? What happens if there’s another regulatory delay in October though? I realise your stating “it’s a done deal” and all but I got stung a couple of years ago after listening to the certainties that were being given by members that I thought knew what was going on AND were honest. My bad. 😑

Sure, Scenesse approval will happen at some stage (how could such a safe and effective drug with the constant pressure via pleadings from the long suffering and absolutely vulnerable EPP community, not get FDAs approval?... Eventually!) but to say it’s a done deal in October, after all the unjustified, time squandering BS delays and decisions that Clinuvel has suffered over the years, not to mention all the failed prophesying of the past, is disingenuous at best.

I realise you have nothing to gain by saying these things 🙂 but anyone that’s been here longer then 12 weeks would realise that when it comes to Clinuvels Scenesse, as good as things appear, it’s never “a done deal”: not till the FDA literally sign off on the approval papers is it going to be “a done deal”, hopefully in October.

This latest 3 month delay, after having all the FDA titles possible to achieve a speedy approval attached to it over the years:

“”Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling review" for an application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.””

is proof of that.
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Dr Wally
Posted on: Jul 12 2019, 11:38 PM


Group: Member
Posts: 427


“The one thing I found curious is that when speaking about the knowledge transfer between the EMA and FDA, the word "presume" was used”.

I wouldn’t read anything negative or mysterious into that other than PW expressing a little frustration maybe. Unless your the FDA commenting on their processes you are literally presuming yes?

Hopefully having the RTF issue cleared up once and for all today will give the ones sceptical and scathing of management a little more faith that they’re not burying bad news from investors.
——
IGGY I’m certain the infamous Reality Chump (RC) is the mastermind behind at least one of these malignant characters. 😾
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Dr Wally
Posted on: Jul 12 2019, 02:02 PM


Group: Member
Posts: 427


You could ask the same question when we’ve gone up in the past as well for no reason yes? FDA approval will bring absolute certainty and real stability. Until that beautiful day comes about just have faith in the safety of Scenesse. It’s the only thing that matters at this point in time. 😎
——-

But it’s just too easy to simply NOT read post from people you don’t like or post idiotic and immature garbage.
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Dr Wally
Posted on: Jul 12 2019, 01:57 PM


Group: Member
Posts: 427

“no I am patient and like to hang in there until they perhaps reach the $100”

Nobody could ever accuse you of being impatient. 19 years of waiting on a safe and effective drug like Scenesse is a regulatory disgrace and you seriously deserve a medal of some kind. I’m loosing my sh1t after only 9 years and this latest BS delay has literally compounded the frustration I feel. I just cannot comprehend how it could take decades to get such a safe and beneficial drug like Scenesse to this point.

The situation is insane when you consider authorities have been crapping on about a “skin cancer” epidemic for decades (with no signs of abating or effective treatments in sight) while Scenesse has been gathering dust on the sidelines because of the regulatory stonewalling it’s been coping for decades now.

As usual: MONEY talks and small Australia pharmaceutical companies like Clinuvel WALK the extended long and windy **detour** to approval with a few regulatory round abouts thrown in to burn some more time and cash. 😎

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Dr Wally
Posted on: Jul 11 2019, 03:31 PM


Group: Member
Posts: 427


I guess the ones that don’t trust or like management, yet believe in the likes of JH (CUV day trader who identified once as (Reality Check) who benefits financially by confidently expressing his opinions as though they were 100% fact, attempting to sway investors this way and that for a daily earn, will continue to believe what they believe.

JH has guaranteed us multiple times (even contacted certain members via IM to push his agenda) that Scenesse NDA had received a “RTF” letter and that management was not to be trusted. Very compelling JH but I know who I believe thank you very much.

A lesson on so called valued members. 🤡
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Dr Wally
Posted on: Jul 11 2019, 02:24 PM


Group: Member
Posts: 427

Who really knows what the FDA think of the “tanning drug” in 2019 and what they might do to either, clear the way for its safe use or continue with the ignorance and outdated ideological opposition that has pretty much turned this drug approval into a complete farce.

How could they not comprehend by now the obvious massive benefits to the health and lifestyle of the EPP community? How could they not explicitly understand how beneficial EUMelanin is to all humans?

How could they possibly delay and deny again in October when:

Vyleesi (Bremelanotide). The sister Melanocortin with a slightly riskier (negligible) safety profile has been approved already?

““The ultimate mandate of the FDA is to weigh up the risks of the proposed product versus the benefits offered.””

The biggest risk to the EPP community of approving Scenesse would be of drowning at the beach as they’ve been denied the opportunity to participate in normal life activities for so long. 😬

“Karyopharm bags an upset win at the FDA as regulators OK myeloma drug selinexor despite a host of objections”

Amongst a long list of extremely negative data the statement below takes the proverbial cake!

***In one study the FDA cited, the overall survival rate was worse in the selinexor arm.***

“”Then there was the toxicity profile, with a high frequency of treatment emergent adverse events among patients taking the drug. The agency cited a 94% rate of grade 3 or grade 4 adverse event. 10 deaths were due to a fatal adverse event in the main single arm study used for the accelerated approval. And 9 in 10 patients required a dose modification, with a majority requiring 2 modifications.””

“”That case persuaded 8 of 13 experts to vote against an early approval. *****But the 5 votes in favor illustrated the agency’s appetite for new drugs for patients who have run out of options.””*****🤬🤬🤬

Please tell me Why hasn’t Scenesse been approved already??
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Dr Wally
Posted on: Jul 10 2019, 10:21 PM


Group: Member
Posts: 427

“Why is Vyleesi administered sub-Q and not slow-release?

I know right! Somebody wasn’t thinking in the R&D department.🤯🤯

1 night of nasty vs a 2 month long female initiated porn bender..... IDIOTS! 🤣🤣
On second thoughts maybe they made the correct decision.
——-

Go The Blues. Better luck next year you dirty cockroaches! 🥳🥳🥳
No I’m not having a shot at one of the rouges. 🤓
NRL State of Origin.
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Dr Wally
Posted on: Jul 10 2019, 11:18 AM


Group: Member
Posts: 427

This latest BS regulatory delay has been extremely painful and hard to deal with. How much longer can these bureaucrats with the power to make or break put off the inevitable?

Anywayz last time I post anything towards Johnny H, Hamster72 or any other baiter. 🥳🥳🥳 I swear.

Doing good, doing bad, grinding out an earn, who really knows, who really cares.

Scenesse will be FDA approved one day: that, and it’s incredible long term proven safety profile are the ONLY things that matter to me.

The guy behind Hamster profile is calling for others to be banned. Ironic and insane. Jekyll and Hyde has nothing on this person. I have really got up his shirt this time and he is on a banning mission. I mentioned the irony already haven’t I. 🤯

**I also received a couple of IMs from Johnny H** in 2018 telling me in no uncertain terms how much of a big shot investor he was and putting sh1t other members that I’m certain most would see as being fair minded. Why? I outed the IM on the forum and never received another.

He trades this company on a daily/weekly basis (his admission, all good). I actually wasted a decent amount of money listening to his dodgy ramping advice in late 2017.

He brags about his so called substantial investment and the money he has made here. Absolutely NO shame at all. I don’t give a rats how many thousands of shares the person has but I won’t be falling for their garbage again that’s for certain.

The end!
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Dr Wally
Posted on: Jul 9 2019, 06:43 PM


Group: Member
Posts: 427

That’s actually 3 tings GC? 😾 I hope you don’t mind me calling you GC? 😬

1- do you literally know why Clinuvel is keeping low profile? Any chance you could divulge? Don’t know about anyone else but I would love to know.

2- Surely ShareCafe would stop multiple accounts being run from the same device/IP address, no? Especially when their conversing, working together and constantly thanking each other. It’s pretty obvious that a few have had multiple accounts over the years foe whatever reason hey. 😉

3- Rouge really? I thought you would have preferred Goldennnnn! 😽
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Dr Wally
Posted on: Jul 9 2019, 03:06 PM


Group: Member
Posts: 427

I don’t think anybody could deny that the “communiques” and news letters over the years have been anything other than disappointing at best, bordering on infuriating and at times confusing in general.

The question that should be pondered is: WHY did management decide to go all ambiguous and secretive about Scenesse around 2007-8 ish?

At one time they (PW) saw no problem in explaining clearly even on commercial television (as camera pans out over deeply tanned bodies on Bondi Beach) that “if the safety holds up” (I cant remember the rest so I’ll use my own words) the photo protective tan that people desperately want but are damaging and ageing their skin in a futile attempt to attain will become widely available in the not too distant future.

So: Are these guys as incompetent and disrespectful as many believe or have they been forced into this low key behaviour for some other reason?
———

Yes this post was erased because of my allegations about certain member that I wrote below the line. 😐
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Dr Wally
Posted on: Jul 8 2019, 11:25 PM


Group: Member
Posts: 427


I reckon your onto something too. To describe the predicament these shorters (johnnyHamster) might find themselves in if your assumptions of the situation over the coming months plays out as being “dire” would be quite an understatement yes?!😬

“There’s also the possibility of an early PDUFA with FDA completing their review before Oct 6th.”

But there’s no possibility of another regulatory delay leading up to Oct 6th though right? 🤔
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Dr Wally
Posted on: Jul 8 2019, 01:08 PM


Group: Member
Posts: 427

It seems FDA Scientific Workshops and FDA Advisory Committees Meetings are extremely similar things?

Looks like we got the “blunt end of the implant” here as well? Maybe this is what the FDA meant when they mentioned “fast tracking” of Scenesse.😑
6hrs for (EPP) vs 2 full days for (female sexual dysfunction.) Hmmmmmm! I guess that’s fair.
—-
6 hours were allocated for the:
Scientific Workshop for Erythropoietic Protoporphyria (EPP)
Description
Date: Monday, October 24th, 2016
Time: 10 am – 4 pm
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Great Room
Silver Spring, MD 2099
——
female sexual dysfunction (Brem).
“The FDA held a two-day meeting on 27 and 28 October 2014 to advance the agency’s understanding of female sexual dysfunction. During the first day of the meeting, the FDA solicited perspectives directly from patients about their condition and its impact on daily life.”
——
EPP (Scenesse)
“The public workshop is intended to discuss how best to facilitate and **expedite** 🤣😂 the development of safe and effective drug therapies to treat signs and symptoms related to EPP. “

“FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on disease symptoms and its impact on daily life, experience with current treatment regimens for EPP, and various aspects of clinical development of products intended to treat EPP.”
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Dr Wally
Posted on: Jul 5 2019, 01:24 PM


Group: Member
Posts: 427



The next “Communique” shouldn’t be that far off? Will be extremely Interesting to see if management express any frustration possibly outright anger over the FDA approval of the first Melanocortin (Brem). A diplomatic response if any might be given if the past is anything to go off, but can they really be blamed for kowtowing to the ones with the power to stall the process indefinitely and ultimately destroy everything they’ve worked for over previous decades?

With the FDA “Fast Tracking” of dangerous ineffective drugs like (selinexor) their most recent objectionable approval its no wonder their processes and integrity are being questioned by more and more people. The EPP community and many others are sensing that the playing field is not at all level at best. A large media backed campaign to shine some light on the pros and cons of Scenesse by the APF might be necessary if another costly delay occurs in October? 😎
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Dr Wally
Posted on: Jul 4 2019, 12:24 PM


Group: Member
Posts: 427


“I'm guessing the main reasons for **not holding an advisory committee** is due to exceptional circumstances i.e. difficulty validating efficacy or having a truly blind trial because of tanning.”

Sorry Mac but your guessing makes absolutely no sense. “difficulty validating efficacy or having a truly blind trial because of tanning” is the primary reason the meeting was arranged in the first place. 😐

Meeting up and talking with experts in the field and EPP sufferers literally expressed “real life” evidence to compensate for the so called ““difficulty validating efficacy”. That one off meeting really did provide the “optics” you say the FDA aren’t interested in: I’d say your right on the money with that guess Mac.

A sceptical opinion might be to suggest they (FDA) weren’t to keen on giving sufferers another chance to provide even more Scenesse affirming “optics” with a second meeting because it would’ve only created another wave of criticism and bad press, confusion and a tonne of inquiries into why the F this important drug hasn’t been approved already.

Approving toxic, sometimes deadly and barely efficacious drugs in half the time it’s taken to evaluate the ultra safe and effective Scenesse is mind boggling to most. Can only guess how frustrating it must be for people suffering from the debilitating symptoms of EPP.

#EPP Lives Matter!
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Dr Wally
Posted on: Jul 3 2019, 11:51 PM


Group: Member
Posts: 427

I know one thing for certain: the posting here would have been anything but dire if our original PDUFA date of 8 July 2019 had have been honoured.

On another cheerful note: (I’m of the opinion) the only reason the FDA didn’t bother holding the “advisory committee meeting” as part of the final review of Scenesse was because they realised that It was certain to make them look extremely bad.

It seemed like an extremely positive “let’s get this drug out to the US EPP community for summer” gesture at the time but looking Bach now I honestly believe they only did it to avoid the added and unwanted pressure and questioning it would have generated.

Another multiple hours length meeting with long suffering EPP patients explaining how Scenesse has given them life, experts in the field supporting the use of the drug with the media recording ONLY great, positive things being said about Scenesse as well as all the social media. It was definitely not something the FDA needed especially with a 3 month delay up their sleeve.

Anywayz, 3 more months of ramping, shorting, exaggerating, speculating, winging, wining and niggling: woo hoo! 😑

No I’m certain there’ll be plenty of positive posting and value adding events that will see the SP smashing through the 40 mark well before October.
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Dr Wally
Posted on: Jul 2 2019, 11:59 PM


Group: Member
Posts: 427


Here we go again! ..... You are completely fking mad!

I have absolutely nothing to hide unlike yourself Johnny. My handle on that forum was actually shane101. Your obsession with the eagle is a worry.

Have fun shorting CUV tomorrow! 🤡 goodnight!


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Dr Wally
Posted on: Jul 2 2019, 11:26 PM


Group: Member
Posts: 427

**Apologies to you Endymion96.**

You were correct in stating that a “spoon full of Scenesse” might be possible in the not too distant future.

My ignorance led me to believe (for many years) that Scenesse was literally and solely the implant formulation of Afamelanotide.

After feeling guilty of being a Know it all smart ass to you yesterday I thought I should do the right thing and fact check my ass: so I did and it’s clear that I was wrong. No need to thank me either ok.🤓 The facts are the facts!

“From today onwards, Clinuvel will adopt SCENESSE in **all references** to the drug in its further global clinical development.” 2010

https://newswire.iguana2.com/af5f4d73c1a54a....pdf?download=1


This is the second time I’ve had to apologise to you now you know.
I jokingly stated in a post one night (around 2004-5) attempting humour 😑 that I thought you, Endymion96, was actually Pier Walnut (Dr Philippe Wolgan) because of your extensive knowledge back then and the Melanotan.org boss Scotty totally freaked out and made me PM you with an apology. 😬 bit hysterical I thought as it was clear that I was joking with everyone.
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Dr Wally
Posted on: Jul 2 2019, 04:00 PM


Group: Member
Posts: 427

Don’t bother with this person any further PLEASE otherwise the moderator will delete this whole section of revealing posts and the true mentality of this person will go unnoticed once again.
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Dr Wally
Posted on: Jul 2 2019, 03:50 PM


Group: Member
Posts: 427


I’ve noticed on a couple of occasions that Hamster72 post have been pulled not long after posting.

Moderator, can you please leave these up so that the rest of the members here can see for themselves what this person is really about?
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Dr Wally
Posted on: Jul 2 2019, 12:00 AM


Group: Member
Posts: 427

“Hopefully there is a bull waiting behind the cage of fda approval”

That’s a great analogy NewToCli. I can clearly envision a raging bull that’s been poked in the ribs by many a matador though out the years whilst being kept in a dark dinghy tunnel and treated like sh1t, fuming and stamping preparing to get out and run amuck: hang on if you swap out the bull for the EPP community and the matador for the regulators (specifically FDA) you’ve got yourself another fitting analogy. 🤓

If the uncertainty vaporising, Clinuvel pipeline enabling, decision to FDA approve Scenesse (Afamelanotide) doesn’t release a raging beast, what decision ever will?



Derp derp derp! ..... I think I can hear the mutterings of a fraudulent faker!..... Boooooo! 🤡
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Dr Wally
Posted on: Jul 1 2019, 05:55 PM


Group: Member
Posts: 427

“Mitsubishi is doing it Not Cuv.”

Sorry are you suggesting Mitsubishi is producing Afamelanotide pill form? Surely not?


“What new has Cuv delivered so far?”
Who knows their treating us all like mushrooms aren’t they! 🤓

Seriously who knows what incredible things they’ll have to divulge once FDA sign off on Scenesse but I’m certain there will be plenty: much known already and a lot that isn’t. Till that happens we most likely won’t hear explicit details on anything of substance. As frustrating as that is I have faith in management and accept that that’s how it has to be for now.

We’ve known the fundamentals and the potential for years and they haven’t changed at all, gotten stronger if anything. Just hoping their keeping on top of the latest developments in this space so that things can really get rolling once FDA approved. Im sure they are.
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Dr Wally
Posted on: Jul 1 2019, 04:29 PM


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Posts: 427

As much as I’d love to get my hands on the implant (scenesse) taking a spoonful of them would be the last thing id want to do. A bit harsh on the throat don’t you think endymion96? 🤣 Pill form on the other hand 👍🏽👍🏽👍🏽

Just kidding mate, please don’t hate me for having a joke with you I’ve got no friends here as it is. 😭 Billy Boots maybe😬 hopefully.


It’s great news and you would hope that Clinuvel would be all over these advancements in peptide delivery (2017ish published) and incorporating them into their future Afamelanotide formulations if at all possible.

With game changing peptide advancements like this coming to light over the past couple of years you have to wonder where it leaves the topical/ transdermal formulations. A pill would have to be the most superior way to injest Afamelanotide for anyone other than EPP or similar conditions.

Could be another reason why we haven’t heard anything about the legendary photo protective tanning cream. Could be a pill instead? 😎
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Dr Wally
Posted on: Jul 1 2019, 01:20 PM


Group: Member
Posts: 427


Don’t worry Billy the positive Scenesse data, that has been demonstrated and totally consistent for decades now, will eventually prevail over stupidity, fear and ignorance and any other rotten force that has kept this brilliant drug out of circulation.
—-
“I just submitted the paperwork to pull the FDA's inspection records for Evonik Birmingham again. It should take about 2 weeks, and I'll post what I find.”

Top work Johnny Hamster will be keeping an eye out for your integral findings!
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Dr Wally
Posted on: Jun 30 2019, 11:09 PM


Group: Member
Posts: 427

You are exactly right Schlitzo but why shouldn’t I respond to an obnoxious fake, with multiple accounts accusing me of being a “plant”? Im not the one trading (shorting possibly) this stock daily and passing opinions off as facts that have yet to be proven..... Anywayz moving forward or possibly backwards. 🤯
—-

FDA -
“Speeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments.
The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible”

“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.”


Fast Track, orphan status, Breakthrough Therapy, Accelerated Approval, rolling review, Priority Review: is there an FDA designation (for a speedy process to approval) that Scenesse hasn’t had attached to it over the years?

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

Even with all these glorious titles that supposedly enable more frequent access to the FDA via meetings and correspondence and close scrutiny of NDA modules as they were completed (“rolling review”) so that nothing would be looked over as the NDA was thoroughly examined section by section to speed the process up significantly so that safe drugs can get out to desperate patients quicker, Scenesse gets shafted with another costly time wasting delay. THEN another (proven safe but you could have said at the time, slightly more “safety” concerns) Melanocortin (NOTE no tanning effects) is FDA approved.

If this isn’t conclusive evidence that the “tanning” aspect of Afamelanotide (Scenesse) I don’t know what is!

Yes, I am angry about the time it’s taken to get this exceptional drug to market and I put the blame squarely at the feet of regulators (mainly FDA) for the years that have been quite literally wasted for no good reason other than ignorance and irrational tanning fears if you consider them good reasons. Considering the “tan” is the all important factor of the drug that enables it to be such an effective photo protectant and makes my argument seem insane just remember the facts “ there is no such thing as a safe tan”. We all know this statement is absolutely ludicrous but that is the official rhetoric so go figure. A change in the rhetoric is a comin I reckon.

By no means am I trying to paint management as being perfect I just can imagine how difficult it must be trying to do the normal communications with investors and broader market and not come off looking stupid when the regulators are making the process as convoluted and time consuming as they possibly can and you can’t possibly call them out for it without risking further costly delays.

Now I realise that it wouldn’t be possible (would it?) that a little pressure from big Pharma, with billions at risk of superior photo protection coming along and destroying the status quo after Scenesse FDA approval, could be behind their reluctance to accept the positive data and that’s why I would never accuse FDA of corruption being at the heart of their never ending resistance of safest most important photo protectant of all time. Not a chance.
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Dr Wally
Posted on: Jun 29 2019, 12:39 AM


Group: Member
Posts: 427

This post has **nothing** to do with Scenesse or Clinuvel. It’s almost as immature as asking for “thanks” to make wally sad” and if you like Reality Check please DO NOT READ FURTHER!!
And I apologise in advance for this BS but whaderya do? 😑

“You write the same things over and over doc... what gives?”

You’ve got multiple accounts here and you think no one knows🤣🤣 what gives?

“Just please quit bitching about how long it took to make your money.”

???🤪 🤯 I don’t brag about how much I’ve invested or made here. Why would you bother.
You youse to make the same kind of idiotic and straight up random accusations when posting as Reality Chump. Get a grip Johnny H amster!

Your an overly confident multiple account faker that regularly states your convoluted opinions as fact. I actually lost money (bought a batch for $8 instead of $6.50) after listening to your crap many years ago (my stupid fault of course) so you really get my goat but I take everything you say, be it your hamburger72, reality chump or Johnny hotshot accounts with a speck of salt these days.

You can’t be all bad though as youve invested in Clinuvel and seemingly understand its potential so like I said yesterday: good luck with it all my fake @$$ brother! 😉 or sister?
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Dr Wally
Posted on: Jun 28 2019, 04:07 PM


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Posts: 427

Shorters aren’t the main problem here though are they. They do seem to flourish on uncertainty though and until the FDA quit with their baseless resistance to Scenesse much uncertainty will remain unfortunately.
The SP prior to FDA approval is irrelevant really.

Sorry that was Corbin that mentioned selling.

From what I understand shorting of stocks is beneficial to the market but I don’t want to get into that as I have no idea really. Ask RC / JH/ the hamburger72 I’m sure he/she will have some valuable advice that you can take to the bank.
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Dr Wally
Posted on: Jun 28 2019, 03:40 PM


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Posts: 427

19 years is a hell of a long time to wait isn’t it! . You must have wondered many times over the years: how and why has it taken this safe drug decades to get to this point when so many dangerous and toxic, even deadly drugs get approved in much shorter timeframes? And still theres much uncertainty in the market surrounding this company because of regulatory delays for unknown reasons.

It’s bad enough you’ve had your coin tied up in Clinuvel all these years waiting on ignorant regulators twiddling their thumbs and scratching their heads thinking of ways to deny Scenesses existence instead of simply accepting the undeniable data and obvious benefits to people’s health that Afamelanotide will bring.

The only thing you could do now that would be a bigger mistake than to have faith that these insensitive bureaucrats would be able to evolve their thinking and embrace a super safe and effective drug in a fair and timely manner, would be to sell now and miss out on the incredible returns on your investment soon after the inevitable decision is granted.
——-

The American Porphyria Foundation have had it with these dinosaurs.

To put the EPP community through another long hot summer with some BS delay when there is absolutely NO SAFETY CONCERNS WHATSOEVER says it all and they should be ashamed but I’ll bet their not.

2) CALL TO ACTION
The American Porphyria Foundation, on behalf of our members, views this change in review date as an unacceptable delay by the Food and Drug Administration. Patients with Erythropoietic Protoporphyria (EPP) have waited long enough for a full review of this treatment that has shown to be safe and effective over a dozen years of use and has been approved by the European Medicines Agency. It is not acceptable and unsustainable that U.S. patients only have access to Scenesse through great expense and travel. It is time for the FDA to #approveScenesse.

For some reason they don’t blame Clinuvel management at all from what I can tell.


———
Not so far up my own @$$ as to suggest my posts are anything other than *opinion* unlike (Reality Chump- JH - Hamster72). Nor do I need to post here under multiple identities. What’s up with that?
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Dr Wally
Posted on: Jun 26 2019, 04:12 PM


Group: Member
Posts: 427

Look billy once the SP gets ramped up off of the back of much talk of milestone events like ASX200 inclusion get **blown up and out of all proportion** your friend RC is the type that can “smell it” when the SP is topping out and the offload begins.

Selling then buying back in a number of dollars lower when reality and in some cases panic kicks in and the whole process goes around and around and around. A few thousand here and there adds over the years.

Do you remember what drove the SP up last time to 29.999 before it crumbled away to approx $22?

Selling on the news after weeks, months of ramping is the norm here.

If FDA approval doesn’t bring absolute certainty and end most of the games that people like RC play daily (with Clinuvel) nothing will. (My slightly educated opinion)

Their not doing anything illegal so you just have to have a really thorough understanding of what your investing in I guess and keep your eyes open and observe and don’t believe the hype! And if you think RC is going to help you out then you might want to think again. RC is not as stupid as he/she makes out.
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Dr Wally
Posted on: Jun 26 2019, 11:38 AM


Group: Member
Posts: 427


“You loved the company and drug for years and now you're so negative. What gives?

Plants abound ”
—-
Grow up sociopath you are the biggest fake here!!

My opinions (that admittedly not many agree with) and occasional tongue in cheek posts have been consistent since day one.

I know you are also here as **Johnny H** and you were here as the infamous grub **Reality Check (RC)** until you irreparably disgraced yourself.

Sad thing is you get plenty of “thanks” as the full of sh1t ramper JH and you had a decent amount of thanks as RC if I remember correctly so good luck to you and ALL who believe your lies.

Your not
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Dr Wally
Posted on: Jun 25 2019, 04:41 PM


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Posts: 427

Any chance you could give your thoughts on how it was possible that Bremelanotide got FDA approval before Afamelanotide?

It’s a fair question that doesn’t indicate anything other than how the F did this happen?

I see the decision by the FDA as actually making it 100% impossible for them to now deny Scenesse so it’s a positive thing.

Who are the fools “selling or getting out”?
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Dr Wally
Posted on: Jun 25 2019, 02:04 PM


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Posts: 427



“I'm $34.76 bid for 5k.”

Be careful you don’t get burnt Hamster72.

I’ll pay $200 via PayPal for a semi coherent reason as to why:

A drug from the Melanocortin family (Bremelanotide) with dubious benefits that barely exceed placebo, extremely similar to Clinuvels Scenesse (Afamelanotide) only it (Afamelanotide) has even LESS risk associated with it as it has NO crossing of the BBB just got approval for a condition that fades into absolute insignificance when you consider ALL of the life changing/saving/ therapeutic benefits that Scenesse (afamelanotide) will bring, was approved last week.

Don’t get me wrong, I don’t see Brems approval as a bad thing (has to be good) just baffles my mind as to how it could be cleared before Scenesse. There has to be a logical reason behind it all yes?

Is there something seriously wrong with this drug that after decades of nothing but positive data we don’t know about? Please don’t mention it here if there is ok. PM me with that information. 🤓

Is management so inept that they are the reason decades later we still wait with some even fearing outright rejection?

Is FDA (for some unknown reason) the main reason behind the never ending regulatory journey?

So much uncertainty still exists. Can you imagine what people think is behind this never ending journey outside of the forums? It wouldn’t be uncertainty it would more likely be complete confusion as to what’s been going on all these years and what might happen with the mythical tanning product or drug or whatever people believe it to be.

Is the approval and astronomical potential really “baked” into the SP right now?
Thinking solely EPP and serious associated conditions is it even close?
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Dr Wally
Posted on: Jun 25 2019, 11:40 AM


Group: Member
Posts: 427



The data is clear and everybody (even FDA) understands that Scenesse is better than safe.

What’s holding Scenesse down is exactly the same issues that stalled its progression back around 2005. Is it possible that FDA will move forward with a modern understanding free of irrational fear this year? 2020? 2021? Only the bureaucrats inside the FDA would know the answer to that multi billion dollar question.

Some say it’s managements fault the FDA won’t approve this drug. The same management that run the company so well financially.
What can you possibly do when the most powerful of regulators has been ideologicaly opposed to your “tanning” drug for so long? Keep your head down and let the data and EPP community do the talking and hope for the best I guess.

The FDA will eventually be forced to approve Scenesse but if it doesn’t happen on this next date around October you can be assured that EMA style time wasting games have begun if they havnt already.

Why would FDA approve (Bremelanotide- Melanocortin) over (Afamelanotide- Melanocortin) when Afa has even less risk associated with it and the known ability to change thousands of lives (EPP) and protect millions more from skin cancer with many more benefits to be realised.
—-
Billion dollar (toxic) sun cream industry - There’s no such thing as a safe tan guys! nothing to see here. Go back to sleep!

Clinuvel- F you there is! And we have decades of proof. Your days are numbered sloppy!

EPP community- why are we still suffering? Why can’t we access this safe therapeutic drug so we can fully participate in this life? Another summer of darkness and isolation. Why would you do this to us again? Is the drug unsafe or something??

FDA- Hmmmm how much longer can we pull the rug over everyone’s eyes here delaying the inevitable.
We realise that the “tan” is nature’s perfect photo protection and there’s no logical reason in 2019 that it should be feared anymore but if we approve Scenesse our 4 decade old rhetoric and cosy relationship with big pharma and the status quo will be totally up ended. Everything will change. 😱

Clinuvel and EPP community- everything will change for the better you bunch of F Witts! Get on with it already!! 🤬 Your embarrassing yourselves now.
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Dr Wally
Posted on: Jun 21 2019, 03:18 PM


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Posts: 427

Moto? Pier must have taken off for a late lunch, I can only see a dusty old mope head. Might be Iggy??😸
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Dr Wally
Posted on: Jun 21 2019, 02:56 AM


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Posts: 427

As much of a rip off as the approval of Brem ahead of Scenesse would be I guess it would have to be seen as extremely positive in that if the FDA feel that this way less deserving Melanocortin should be approved then how on this great F ing earth could they possibly deny our incredibly beneficial Melanocortin in October.

It wouldn’t surprise me to see a negative outcome for Brem tbh but it wouldn’t be an indication whatsoever of Scenesses chances of FDA approval. The two drugs are closely related but are worlds apart in the benefits they bring and the populations they treat.
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Dr Wally
Posted on: Jun 20 2019, 01:51 PM


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Posts: 427

Yeah I should have said “you might not wake up in the morning AFTER (hopefully)”. 😵

It couldn’t possibly happen could it?

For what reason other than corruption or absolute stupidity based on outdated ideological differences would they deny this drug?

Too much good data in 2019. Also too many people in need of this safe treatment and too many eyes watching over this final stage of the process for any more shifty BS to take place I reckon.

By shifty I mean bureaucratic shiftiness.
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Dr Wally
Posted on: Jun 20 2019, 01:13 PM


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Posts: 427

I don’t believe there’s anything new happening here Billy other than the realisation by the market that the FDA will acknowledge and accept the long term ultra positive data and come to their senses in October 2019 and everybody knows that that one decision will change everything forever.

Sure it’s possible that the FDA might not approve Scenesse but it’s also possible you might not wake up in the morning either yes?

Once the uncertainty of this drug has been eliminated via a positive FDA decision everyone will be on the same page with the knowledge that the vast potential of this company will stand every possible chance of being realised. The only question left to ponder then will be how many billions of dollars will be made over the coming years.
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Dr Wally
Posted on: Jun 18 2019, 08:30 PM


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Posts: 427



“It is great to see CUV growing exposure in China.”

If only it were true. 😭
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Dr Wally
Posted on: Jun 18 2019, 06:14 PM


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Posts: 427



First Chinese citizen treated with Scenesse implant, Wai Yu So Tan, has revealed to Chineese media that his lifelong dream of becoming an authentic looking member of his local provinces Jackson 5 cover band has now become reality after receiving official confirmation that the communist party will be supplying his implants so long as he performs monthly at official party meetings in Pinggu district.

Wow! 🥳🥳🥳
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Dr Wally
Posted on: Jun 18 2019, 12:32 PM


Group: Member
Posts: 427

Did you even notice that I didn’t mention (even one time) the long term proven safety or therapeutic value of Scenesse in that last post? your a hard man to please. 🤨
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Dr Wally
Posted on: Jun 18 2019, 12:15 PM


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Posts: 427

No it’s not greed after all the years wasted because of irrational fears and ignorance it’s simply a fair realisation of a game changing and well proven product with NO negatives and a 99.9% chance of FDA approval. With the slightest of insight into this ginormous photo protection “space” it should be rather obvious that the company is still extremely undervalued. We should have been at this stage years ago though.

And photo protection is but one of many incredible aspects of this company.

Only a whack job conspiracy could prevent Scenesse from becoming available. 😑

Can you imaging what it will be like once ALL uncertainty has been erased the very second the FDA cease with their silly resistance to this vital drug? The feeding frenzy hasn’t even started yet but there’s blood in the water.
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Dr Wally
Posted on: Jun 18 2019, 12:59 AM


Group: Member
Posts: 427


“they never ever live up to their own timelines and, yes, they bury stuff. What ever happened with the cosmetic line that was delayed due to a supplier issue ? That kind of misleading statements, I don’t like”

It’s definitely been a frustrating ride over the years up until recent months. Any chance you could share your thoughts on why these guys (Clinuvel) would choose to act this way when they seem to be managing the rest of the company so competently?

Could it be that The FDAs moving of the goalposts, changing of the rules and creating delays whilst hoping that negative safety data would turn up to end the drugs prospects, are behind the seemingly sh1thouse investor relations?

“The strong earnings growth is reflected in impressive double-digit 37% return to shareholders, which paints a buoyant picture for the company.

CUV is financially robust, with ample cash on hand and short-term investments to meet upcoming liabilities. This suggests prudent control over cash and cost by management, which is an important determinant of the company’s health.

Looking at CUV's capital structure, the company has no debt on its balance sheet. This implies that the company is running its operations purely on off equity funding. which is typically normal for a small-cap company. Therefore the company has plenty of headroom to grow, and the ability to raise debt should it need to in the future.”
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Dr Wally
Posted on: Jun 15 2019, 08:21 PM


Group: Member
Posts: 427


ASX200 inclusion does nothing to eliminate any of the uncertainty that still exists of a possible FDA rejection. 😱 I’m sure there’ll be interest because of it that didn’t exist before but that might take some time??

I’m 95% certain that that won’t happen but there are many out there that are of the belief that the FDA will either drag this out for a couple of years yet (a la Euro) OR simply say “NOPE” erasing the hopes of the EPP community of living a normal life without to hassle and cost travelling to the other side of the world for access to the super safe drug AND devastating investors financial futures all because of idiotic fears of “tanning” abuse by the masses.

So even at this late stage of development it’s just too risky for some to invest especially if your not thinking outside of the box by only factoring EPP into the equation.

FDA approval on the other hand (obviously) evaporates any remaining uncertainty about the future of Clinuvel and guarantees that the incredible potential of this drug, that has been dreamt and talked about for decades, will 100% be realised over the next few years (post approval)

For what it’s worth I’m of the opinion that this game changing potential is no where near “baked into the current SP either. What other drug or company can you compare Clinuvel and it’s enigmatic, controversial drug Scenesse to? None! 😎
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Dr Wally
Posted on: Jun 11 2019, 07:54 PM


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Posts: 427


Agreed!
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Dr Wally
Posted on: Jun 11 2019, 06:42 PM


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Posts: 427

🥳🥳😛🤪😖😣😞🤯🤐🙏🏽

SP is staying strong.
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Dr Wally
Posted on: Jun 11 2019, 02:02 PM


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Posts: 427

Yes it’s rather obvious I know.... This latest “3 month delay” has really effected me. If it happens again in, whenever the new date is, Sept, Nov, Oct?? I’m going to throw my gigantic plastic blow up walnut straight in the fireplace: whilst it’s alight! 💀 💀💀
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Dr Wally
Posted on: Jun 11 2019, 01:28 PM


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Posts: 427

When there’s nothing left to say, about the longest running display of regulator decay, keeping the safest and beneficial of drugs on replay, we at the FDA simply say, delay, delay, delay, DELAY!

I reckon this statement by the FD of A would look good plastered on the back of a poo brown turtle neck skivvy. Any chance of getting a couple of them printed up PAD? 🤓

I’ll send one out to IGGY and RC as an early Christmas present.

I can see IGGY powering down to his local village chemist (drug store) on his electric scooter to withdraw his pension to purchase a tube of Cimetidine sporting one of these metrosexual fashion statements. ✌🏽
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Dr Wally
Posted on: Jun 10 2019, 03:59 PM


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Posts: 427

“I’m the context of “safe tan” from UV exposure it makes sense that it’s all dangerous.”

But to say it’s “all” dangerous is as basic,unbalanced, unscientific and unhelpful to Scenesses cause as saying that “all” water is dangerous to a company attempting to bottle it for consumption. It’s just straight up wrong so to me it honestly makes little sense.

What about the all important Vit D synthesis that needs strong UVR to occur. How can it possibly be “all” dangerous: it simply is not. . For whatever reason some people are reluctant to acknowledge the obvious nuances in this space.

It’s too easy to simply say “there’s no such thing as a safe tan” but it’s a dumb statement. The demonisation of sunlight by authorities has made many people hysterical. It’s done way more damage than its prevented. The results of which have been coming to light over the past couple of years. Multiple serious diseases and irreversible eye damage.

“You only tan once you get DNA damage and then alpha MSH is released to trigger the tan and possibly DNA repair also (this part isn’t as clear)”

“It has been traditionally believed that skin pigmentation is the most important photoprotective factor, since melanin, besides functioning as a broadband UV absorbent, has antioxidant and radical scavenging properties.
Besides, many epidemiological studies have shown a lower incidence for skin cancer in individuals with darker skin compared to those with fair skin.
However, there is growing evidence that the relationship between pigmentation and photoprotection is far more complex than assumed.
It has been suggested that UVR-induced photodamage and its repair are signals that induce melanogenesis. To put it another way, epidermal pigmentation may represent the mammalian equivalent of a bacterial SOS repair mechanism.”

Sorry edited a couple of times there.
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Dr Wally
Posted on: Jun 10 2019, 12:48 PM


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Posts: 427


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671032/


The actual science is so clear and the cancer preventative properties have been well understood for many years but still were feed the “there’s no such thing as a safe tan” BS.

“Human skin is repeatedly exposed to ultraviolet radiation (UVR) that influences the function and survival of many cell types and is regarded as the main causative factor in the induction of skin cancer. It has been traditionally believed that skin pigmentation is the most important photoprotective factor, since melanin, besides functioning as a broadband UV absorbent, has antioxidant and radical scavenging properties. Besides, many epidemiological studies have shown a lower incidence for skin cancer in individuals with darker skin compared to those with fair skin.

Skin pigmentation is of great cultural and cosmetic importance, yet the role of melanin in photoprotection is still controversial. This article outlines the major acute and chronic effects of UV radiation on human skin, the properties of melanin, the regulation of pigmentation and its effect on skin cancer prevention.”

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Dr Wally
Posted on: Jun 10 2019, 12:26 PM


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Posts: 427

While the comments are mostly true, the real reasons behind this idiotic, wasteful (in terms of life and of finances) glacial wait that is certain to end with Scenesses approval primarily because of drug safety and EPP community pressure, are not so clear (to me). You obviously see things completely differently. That’s ok. Nobody knows the actual truth behind this unnecessary and unfair wait just yet.

It’s my opinion that the FDAs long term ignorance and ideological opposition and deeply seated irrational fears of a drug that “tans” but ironically this “tan” actually photo protects like nothing else on this earth can and actually repairs the skin helping to prevent skin cancers, has been behind at least 90 plus % of it.

Why the FDA didn’t jump at the chance to get absolutely behind this drug years ago is going to be a very interesting story to hear.

Having the most powerful regulator opposed to your drugs existence for decades, unable to publicly criticise them without potential serious (further time squandering) consequences, seemingly unwilling to accept the undeniable evidence has forced them into this behaviour. I don’t for one minute believe they look upon shareholders with contempt I might be wrong.

I understand it’s fking absolutely frustrating but blaming management when the stubborn resistance from regulators, virtually world wide, for such a safe and beneficial drug, is seemingly so clear (to me) accomplishes what exactly? Clinuvel management don’t seem to be as stupid as some people think based on the way they run the financial side of the company. Am I making a critical mistake basing my thinking on this?

I had footage from 2007 ish (channel 7 news story- OZ) on my DVR of Dr Wolgen looking out over Bondi Beach (in between multiple close up shots of deeply tanned bodies) spruiking the potential of Scenesse and actually stated that if its (safety) were to hold up, wink wink nudge nudge the photo protective drug (seen solely as cosmetic by most) would become widely available in the not to distant future.

Clearly their approach to publicity changed dramatically at some point for some reason. I believe they’ve gone done the route of “non specific communication” for necessary reasons but things will change on a monumental scale once FDA approved that’s for sure.
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Dr Wally
Posted on: Jun 9 2019, 07:33 PM


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Posts: 427

So X-ray, I guess theres little chance of you purchasing a slick T off of PAD with - Thanks to a walnut called Pier, I’m now a multi millionaire! - embroidered across the back then?

Picture of a digital clock at 11:59 on the front maybe? 🤓
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Dr Wally
Posted on: Jun 9 2019, 01:03 AM


Group: Member
Posts: 427

Now ur cookin! 😎

I realise its early on in your new endeavour but what about working on a stylish polo with an embroidered logo that even P Walnut would be keen to get about in?
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Dr Wally
Posted on: Jun 8 2019, 11:11 PM


Group: Member
Posts: 427

Yes they definitely should have stuck with the original lizard. It was a very solid no nonsense logo that had a really good feel about it.

What about instead of “frilly”: “Clinuvel somewhere and “Potent 100% natural photo protection” so people can get a grasp of what it’s all about. 👍🏽

Or potent 100% natural skin cancer prevention? That would get people interested and asking questions quick smart.

The AA sequence is a great idea nice touch. I’d be happy to wear it about (and pay a decent dollar) if it was on a quality shirt just saying.😎
  Forum: By Share Code

Dr Wally
Posted on: Jun 4 2019, 03:56 PM


Group: Member
Posts: 427

I haven’t sold **1** share since investing in 2010...... Not 1.

Also I haven’t opened multiple accounts here like many others have. I chose this stupid name in jest and stuck with it for better or for worse and as yet I haven’t disgraced myself to the point where a new share cafe account has been needed - yet.😆

Look when I post I realise it’s a repetitive message but there are thousands of people that come here occasionally for information and never comment. My message has always been about Scenesses safety (sorry mcgyver) efficacy and that eventually those strong and long term proven aspects of this photo protective drug will see it approved and glory will be had by all with the foresight to see what 99% of others haven’t.
  Forum: By Share Code

Dr Wally
Posted on: Jun 4 2019, 03:21 PM


Group: Member
Posts: 427

Fair call except for the “bogey man” part. To believe that most regulators have been ideologically opposed, irrational and totally hysterical over the years to anything in the sunlight, tanning space wouldn’t be far from the mark would it?

I guess we’ll all find out the truth one day as to why it’s taken so long. Hopefully sooner rather than later.
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Dr Wally
Posted on: Jun 4 2019, 02:57 PM


Group: Member
Posts: 427

I’m not sure what you mean Hamster?? I was very confident that 8 July was going to be the day everything changed for the better.

Alls I know is that if I didn’t explicitly understand the safety and effectiveness of this special drug THERE IS NO WAY I would have invested even 1 tenth of what I’ve invested. It’s given me 100% confidence that approval will eventually be given so when the SP drops or another unjustified delay occurs I sleep well at night and never panic about my investment in Clinuvel.👍🏽🙂

Are you IgnoreAnus? 🤡


SAFETY PROFILE!! SAFETY PROFILE!! 🖕🏾

Sorry the last part of my post was directed towards Mcgyver. I get the feeling it’s not going to matter😑
  Forum: By Share Code

Dr Wally
Posted on: Jun 4 2019, 02:36 PM


Group: Member
Posts: 427

“The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision”

What would be your thoughts on the situation If we were to get near the “goal date of 6 October 2019” and the FDA decide that they need even more time to study the data? Say another 3 months or so. For how much longer will you be so understanding of the FDAs processing of Scenesse?

Should it really be this time consuming to get such a safe and effective drug to market? Many dangerous drugs get FDA approval in way less time.

It just makes no sense to me other than to believe that the FDA are still ideologically conflicted and big suncream pharma with their many billions at stake (if Scenesse is approved) are behind the endless resistance.

We have a long term proven super safe and effective (therapeutic) drug, desperately needed by a few thousand vulnerable people that has turned into the longest running saga in pharmaceutical history with another 3 month delay now added.

The uncertainty must be keeping so much investment out of Clinuvel. Some people say the approval is “baked into the SP already but with everything still very much up in the air I don’t see how that could possibly be.
  Forum: By Share Code

Dr Wally
Posted on: Jun 4 2019, 12:59 PM


Group: Member
Posts: 427

I just refuse to believe (foolishly maybe) that Clinuvel management with all the time and FDA resources they’ve had, could have allowed “ deficiencies” be they “significant” or not to occur.

They’ve been solely concentrating on the scenesse NDA and nothing else for obvious reasons. The future of Clinuvel hinges on Scenesses FDA approval.

They’ve had the FDAs close guidance throughout the entire NDA process “drip feeding” the modules to the relevant people for ultra close scrutiny over many years!

Are they (clinuvel) really that inept or are there deeper issues at play that they have absolutely no control over?


"We are sympathetic to the finite resources the US FDA currently has and will patiently wait for the communication on labelling and post-marketing commitments by 6 September,” Dr Wright concluded.

This statement is totally clear in that Clinuvel are “ patiently waiting” on the FDA, not adding or fixing or refining anything their end.


If Clinuvel were knowingly insufficient in ANY area to then publicly communicate and strongly indicate that they’re simply “waiting” on the FDA because they are under resourced would be a straight up unnecessary deceptive lie.

Why would they say that? What would they have to gain?

Scenesse safety will win in the end! 😎
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Dr Wally
Posted on: Jun 4 2019, 12:57 AM


Group: Member
Posts: 427

What could they or should they have done differently?

Do you think the FDA would have approved Scenesse already but for the (alleged) incompetence of Clinuvel management?

We’re Epitans managerial shortcomings behind the initial brushing of the drug by the FDA back in 2004-5?

  Forum: By Share Code

Dr Wally
Posted on: Jun 4 2019, 12:27 AM


Group: Member
Posts: 427



No Seeva. Only AUMelanin. It’s the third type of melanin that’s never mentioned. It’s only found in the skin of indigenous Australians. 🤓
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Dr Wally
Posted on: Jun 3 2019, 11:35 PM


Group: Member
Posts: 427

“It is not unusual to see the FDA extend its own timelines when it finds that it requires more time for review and to arrive at a final benefit-risk assessment,”

Being one of the safest drugs around it’s absolutely mind boggling and I often wonder how it could be that the regulatory process of ultra safe Scenesse has become one of the longest (if not the longest already) FDA approval processes in pharmaceutical history.
To require even more time to review “risk benefit” after all this time when so many nasty drugs have been green lighted over the years in half the time is insulting to ones intelligence.

My plea to the FDA.

I understand that Scenesse is a groundbreaking and game changing technology that flips all the rules and regulations about tanning and sunlight exposure that you’ve been batting on about for four decades now on its head and blows up the status quo in this space and is certain to destroy the billion dollar sunscreen industries ineffective and toxic business model, but for f@ksake think of the peoples health and end this deadly ignorance.

Move forward and embrace the safe future of photo protection and skin care. You’ve been crapping on about a skin cancer epidemic for decades now whilst the answer to this nasty disease has been right in front of your faces for decades and we know you know it.

Hopefully these quotes will inspire you to rethink your disgraceful outlook on Scenesse and the vulnerable EPP community that are counting on your support to lead a normal healthy life.😁

“Stop being afraid of what could go wrong and start being excited about what will go right” Tony Robins.

“Resistance at all cost is the most senseless act there is. -Friedrich Durrenmatt”

“He who rejects change is the architect of decay. The only human institution which rejects progress is the cemetery. -Harold Wilson”

“Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has. -Margaret Mead”
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Dr Wally
Posted on: Jun 3 2019, 10:51 PM


Group: Member
Posts: 427


“There are two major pigment types present in the skin: eumelanin and pheomelanin. Each is made exclusively in melanocytes and each derives from the amino acid tyrosine, which is oxidized and cyclized through the actions of tyrosinase and other pigment enzymes (Fig. 6).
Tyrosinase is the rate-limiting enzyme for melanogenesis and plays a role in converting the amino acid Tyrosine to DOPA and then to DOPA quinone. Eumelanin is a dark brown/black bioaggregate of melanin pigments derived from 5,6-dihydroxyindole-2-carboxylic acid (DHICA) and 5,6-dihydroxyindole (DHI) which themselves derive from DOPA and DOPA quinone (Ito & Wakamatsu, 2003).
Eumelanin is an inert pigment capable of efficiently absorbing UV photons as they enter the epidermis (Hoogduijn et al., 2004). Skin darkness is directly related to the amount of eumelanin present in the interfollicular epidermis. Thus the darker the skin complexion, the more eumelanin is contained in the skin and the less UV is able to penetrate the epidermis.
Heavy deposition of eumelanin in the epidermis explains in large part why dark-skinned individuals are relatively protected from acute and chronic UV pathologies. Fair-skinned individuals, on the other hand, are deficient in epidermal eumelanin and express pheomelanin preferentially (Rees & Healy, 1997).
Pheomelanin is also derived from tyrosine, but there is incorporation of a cysteine during its biosynthesis. Retention of the sulfur atom donated by cysteine is thought to be responsible for pheomelanin's reddish/orange color and its pro-oxidative chemical nature. Pheomelanin is much less able to block UV energy and in fact may synergize with UV photons to promote free radical formation and carcinogenesis in the skin.”


https://www.sciencedirect.com/topics/medici...istry/eumelanin
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Dr Wally
Posted on: Jun 3 2019, 07:42 PM


Group: Member
Posts: 427

What possible influence on this rotten biased unjust process, do people think the CEO or management of our smallish Australian pharmaceutical company with the much maligned “tanning”:drug could have over the all powerful US regulator? Id imagine nil to none.

This frustrating life and money wasting glacial journey full of potential never quite being realised is all the FDAs doing *in my opinion.*

Pushing the date out by a further 3 months effectively wiping any chance of the EPP community gaining access to this vital drug for another US summer for no good reason was not at all expected (by me) after being granted their PR. I really thought they’d woken up to themselves as they must clearly understand by now the game changing health benefits that this revolutionary and absolutely SAFE SAFE SAFE SAFE drug WILL definitely bring if ever allowed.

Have I mentioned the safety profile of this drug yet?? Well it turns out that it’s 10 times safer than 95% of drugs in circulation!! You’d think it had toxic, addictive or deadly side effects like multiple FDA approved drugs that are are widespread in the community and approved in half the time it’s taken Scenesse to get to this point wouldn’t you!

FDA would have realised a long time ago the incredible safety and efficacy and therapeutic value of Scenesse (afamelanotide) and they would have realised also that they have no logical or rational grounds to outright reject it so I guess this latest decision is further proof that they havnt capitulated just yet (obviously) and are still struggling to come to terms with the future of photo protection for whatever reason. More delays for feeble reasons are the only play they have left and they’ve shown that their more than willing to go there to accomplish what?

Don’t despair though, as has been mentioned already this delay changes absolutely nothing concerning the big picture . Scenesse incredible safety’s and efficacy and ever enduring EPP community will eventually force (shame? Not fking likely🤬) an approval out of the FDA at some stage.

Clinuvel 2020 wasn’t mentioned a couple years ago for no reason was it!
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Dr Wally
Posted on: Jun 2 2019, 11:48 PM


Group: Member
Posts: 427


Your poor wife! 😬
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Dr Wally
Posted on: May 28 2019, 07:51 PM


Group: Member
Posts: 427

“for many of us time to wait was enough by now and not in for another 3-5 years of waiting and hoping.”

Of course if you feel it’s time flip a little coin then it’s time. There’s no point having a sh1tload of money on paper and never realising and enjoy it’s power. Take all the profit you need and enjoy it, you had the foresight to invest in Clinuvel so you deserve to profit, it’s all good. 👍🏽

I just can’t see the SP fading significantly for a decade or more. FDA approval isn’t the end of the road by any means it’s actually the beginning of a new and exciting chapter in medical history. FDA approval enables the stunning potential of this company to become reality.

It’s been a long long long road to get to this point but “ it will pay off in the end” as someone wise once said. 😎
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Dr Wally
Posted on: May 28 2019, 05:17 PM


Group: Member
Posts: 427


It’s all very positive and exciting but when you consider the wide ranging potential of this special drug within a few short years of FDA approval $35 SP is just a warm up. 😎

It’s been said that we might see a significant drop in SP not long after approval but I fail to see why that might happen. I just see value adding expansion and incredible growth for many years to come.
  Forum: By Share Code

Dr Wally
Posted on: May 27 2019, 01:25 AM


Group: Member
Posts: 427

“No approval ......... ohhhhhhhh the pain ...... can’t even think about that .”

Me neither!

If the FDA havnt come to terms with and fully appreciate the incredible benefits of this ultra safe photo protective drug by now they never ever will.

It’s obvious that they were ideologically opposed to it for a long long time (slowest fast track approval in pharmaceutical history) but they’ve been working closely with Clinuvel for many years now so they would explicitly know how safe and effective the drug is so the fears of 2004-5 simply could not/would not exist anymore to cloud anyone’s judgment.

Call me biased but in light of all we know (which is probably around 50%) to not approve Scenesse would be the utter definition of stupidity and an inquest into the decision making process would be well and truely justified but I simply cannot see that happening. The drug is needed now more than ever and if the slightest grain of logic exists in this world Scenesse will be approved and ironically hailed soon after by the very same authorities.
  Forum: By Share Code

Dr Wally
Posted on: May 21 2019, 01:41 PM


Group: Member
Posts: 427

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: 427

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: 427

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: 427


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: 427

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?
  Forum: By Share Code

Dr Wally
Posted on: May 14 2019, 02:28 PM


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Posts: 427



“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..
  Forum: By Share Code

Dr Wally
Posted on: May 9 2019, 03:29 PM


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Posts: 427


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. 🥵
  Forum: By Share Code

Dr Wally
Posted on: May 9 2019, 12:40 PM


Group: Member
Posts: 427

“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.
  Forum: By Share Code

Dr Wally
Posted on: May 7 2019, 11:06 PM


Group: Member
Posts: 427



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: 427


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


Group: Member
Posts: 427

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).
  Forum: By Share Code

Dr Wally
Posted on: May 7 2019, 06:54 PM


Group: Member
Posts: 427

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: 427

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?
  Forum: By Share Code

Dr Wally
Posted on: May 7 2019, 02:20 PM


Group: Member
Posts: 427

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. 😐
  Forum: By Share Code

Dr Wally
Posted on: May 1 2019, 12:46 AM


Group: Member
Posts: 427

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


Group: Member
Posts: 427


D'oh! Double post again! Why?🤬🤬
  Forum: By Share Code

Dr Wally
Posted on: May 1 2019, 12:28 AM


Group: Member
Posts: 427

“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. ********
  Forum: By Share Code

Dr Wally
Posted on: Apr 30 2019, 09:36 PM


Group: Member
Posts: 427


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: 427


ironically might make more sense 🤓
  Forum: By Share Code

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


Group: Member
Posts: 427


ironically might make more sense 🤓
  Forum: By Share Code

Dr Wally
Posted on: Apr 28 2019, 07:52 PM


Group: Member
Posts: 427

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”.
  Forum: By Share Code

Dr Wally
Posted on: Apr 27 2019, 08:38 PM


Group: Member
Posts: 427


“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.
  Forum: By Share Code

Dr Wally
Posted on: Apr 26 2019, 09:46 PM


Group: Member
Posts: 427


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. 😉
  Forum: By Share Code

Dr Wally
Posted on: Apr 18 2019, 02:55 PM


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Posts: 427

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: 427

“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


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Posts: 427


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


Group: Member
Posts: 427

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: 427

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


Group: Member
Posts: 427

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: 427

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


Group: Member
Posts: 427



“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: 427

“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: 427

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: 427

“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


Group: Member
Posts: 427

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: 427


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


Group: Member
Posts: 427

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: 427

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: 427

“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


Group: Member
Posts: 427



29.980 Boooooooooooo! 🤣

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


Group: Member
Posts: 427

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: 427


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. 😬
  Forum: By Share Code

Dr Wally
Posted on: Mar 18 2019, 08:10 AM


Group: Member
Posts: 427

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


Group: Member
Posts: 427

“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: 427

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


Group: Member
Posts: 427


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


Group: Member
Posts: 427

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


Group: Member
Posts: 427



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


Group: Member
Posts: 427

Fair and sensible call but we all know what’s going to happen around July. 😎😎😎🥳🥳🥳
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Dr Wally
Posted on: Feb 12 2019, 03:23 PM


Group: Member
Posts: 427

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: 427



“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: 427

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


Group: Member
Posts: 427

“”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: 427

“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: 427

“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: 427

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: 427

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


Group: Member
Posts: 427



“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.

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


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Posts: 427

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


Group: Member
Posts: 427


“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!! 😫😫👽
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Dr Wally
Posted on: Dec 6 2018, 09:36 PM


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Posts: 427

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


Group: Member
Posts: 427

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


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Posts: 427


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


Group: Member
Posts: 427

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


Group: Member
Posts: 427

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


Group: Member
Posts: 427

“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. 🤟🏾
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Dr Wally
Posted on: Nov 20 2018, 10:16 AM


Group: Member
Posts: 427

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


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Posts: 427



“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. 🤓


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


Group: Member
Posts: 427

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


Group: Member
Posts: 427

“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”. 😸
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Dr Wally
Posted on: Nov 13 2018, 01:51 PM


Group: Member
Posts: 427

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


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Posts: 427

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


Group: Member
Posts: 427

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


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Posts: 427

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


Group: Member
Posts: 427

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


Group: Member
Posts: 427

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


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Posts: 427

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


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Posts: 427



Tell me more!! 🤓
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Dr Wally
Posted on: Nov 8 2018, 10:34 AM


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Posts: 427

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


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Posts: 427


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. 😎.

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


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Posts: 427


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


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Posts: 427

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


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Posts: 427

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


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Posts: 427


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


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Posts: 427

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


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


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Posts: 427

Drug safety will trump regulator corruption, preconceptions and paternalistic concerns. It will guarantee Scenesses approval at some stage. Absolutely no doubt about it.
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Dr Wally
Posted on: Oct 23 2018, 12:57 PM


Group: Member
Posts: 427


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


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Posts: 427

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


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Posts: 427


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


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Posts: 427

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


Group: Member
Posts: 427


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


Group: Member
Posts: 427


“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: 427

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


Group: Member
Posts: 427


“ 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. 🤖👽
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Dr Wally
Posted on: Oct 8 2018, 11:31 PM


Group: Member
Posts: 427

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


Group: Member
Posts: 427

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


Group: Member
Posts: 427

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


Group: Member
Posts: 427

“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.**

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


Group: Member
Posts: 427

“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: 427

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


Group: Member
Posts: 427


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


Group: Member
Posts: 427


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


Group: Member
Posts: 427

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: 427


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


Group: Member
Posts: 427


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: 427

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


X-RAY $100 would be (edit) reasonable I reckon. 🤓
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Dr Wally
Posted on: Sep 27 2018, 11:20 AM


Group: Member
Posts: 427

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


Group: Member
Posts: 427

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: 427



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. 😑

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


Group: Member
Posts: 427


“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.




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


Group: Member
Posts: 427


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. 🙂

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


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Posts: 427

Hahaha! Y’all ain’t fooling anyone round here IGGY. 🤣 where you been?
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Dr Wally
Posted on: Sep 11 2018, 06:15 PM


Group: Member
Posts: 427

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: 427


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: 427


—————

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


Group: Member
Posts: 427

1000s of tiny and even single share sells doing a good job at keeping the SP down; for the moment that is.🤐
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Dr Wally
Posted on: Sep 6 2018, 01:27 PM


Group: Member
Posts: 427

“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: 427

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: 427

“ 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: 427

“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: 427

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.##
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