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post Posted: Today, 01:23 AM
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House Bill 759
By: Representatives Parrish of the 158th, Stephens of the 164th, Fleming of the 121st, Welch of the 110th, and Burns of the 159th
1 To amend Chapter 13 of Title 16 of the Official Code of Georgia Annotated, relating to
2 controlled substances, so as to change certain provisions relating to Schedule IV controlled
3 substances; to change certain provisions relating to the definition of dangerous drug; to
4 provide for an effective date; to repeal conflicting laws; and for other purposes.
7 Chapter 13 of Title 16 of the Official Code of Georgia Annotated, relating to controlled
8 substances, is amended by revising subsection (a) of Code Section 16-13-28, relating to
9 Schedule IV controlled substances, by adding a new paragraph to read as follows:
10 "(30.25) Solriamfetol, including its salts, isomers, and salts of isomers;"
12 Said chapter is further amended by revising subsection (b) of Code Section 16-13-71, relating
13 to definition of dangerous drug, by adding new paragraphs to read as follows:
14 "(17.05) Afamelanotide;"

post Posted: Today, 01:09 AM
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Looks like some additional competition in the Vitiligo treatment space...

"Speaking of Vitiligo..."

Vitiligo Clinic and Research Center

Update on IL-15 vitiligo treatment

Posted On: Monday, January 13, 2020 Posted By: John E. Harris Tags: Vitiligo, Vitiligo Research, Vitiligo Treatment
Many have asked recently for an update about the treatment to target IL-15 to induce durable responses in patients with vitiligo. There was a lot of excitement around this approach when we published our paper about a year and a half ago in the summer of 2018 (read about it here), especially from me! The idea was that autoimmune memory cells form within vitiligo spots and are responsible for the return of disease at those exact same spots when treatments are stopped. We discovered that those cells need IL-15 to stay in the skin, and therefore blocking IL-15 removes them, reversing vitiligo, and avoiding relapse of disease when the treatment is stopped. This was all shown in mice, not humans yet. But we did study human skin and found the same cells and same pathways active, so we have good reason to believe that this will work for human patients as well.

Based on these exciting results, I applied for a grant from the Immune Tolerance Network (ITN), a group funded by the National Institutes of Health (NIH) to support human clinical trials to test drugs that could have long-lasting benefit for patients with autoimmune diseases. They thought this was a great idea as well and funded the grant application to prepare for a clinical trial in vitiligo patients. In this trial, we proposed to test an existing antibody that targets the cytokine IL-15. Of course, I helped prepare for the trial, which required getting approval from the FDA to conduct the trial, obtaining the drug, and writing the protocol (or plan) for the trial to follow.

During this process, I obtained support from Medicxi Ventures, a venture capital firm located in London and Geneva, to start my own company to create a drug to target this pathway for vitiligo as well. This is all great news, because it seems that many people (very smart and discerning people) agree that this could be a game-changing new treatment for vitiligo patients. As founder of this new company called Villaris Therapeutics, I have financial ties to the company, and therefore a potential “conflict of interest” or COI with the proposed trial sponsored by the ITN. This means that if I could benefit personally from the success of the trial, there would be undue pressure on me when recruiting subjects, collecting data, etc.

Appropriately, everyone agreed that I could no longer lead the trial for the ITN because of my potential COI with Villaris Therapeutics, and thus the ITN elected a new “protocol chair” and principle investigator to lead the trial. This created a delay, and so the trial did not begin when it was projected, sometime in 2019. It is still planned to start soon, possibly in the spring of 2020, but unexpected delays can always occur, particularly because everyone is making sure the study is done safely and correctly. This is not a fast process and requires lots of patience. But it is still moving forward, and everyone is just as excited for the trial as we were over a year ago.

Now, we at Villaris believe that we are developing an even better drug than anything that’s currently available, and we are putting all of our effort into this. It’s no secret that our drug will target the IL-15 receptor rather than the cytokine, and for many reasons we think this will be a better strategy, more effective and thus longer-lasting, as well as safer. This is important and worth doing right, so we’re taking the time necessary to design this new treatment in a way that will benefit vitiligo patients the most. We actually don’t think it will take very long and hope to be testing it in early human trials within the next 2 years. Things are moving quickly because we’re passionate about this and it is our only goal. I’m working with the best of the best at Villaris – they’re brilliant, passionate, caring, and the personality types to “get it done”. Read more about the team and our approach at the company website at

So, don’t be discouraged that this drug isn’t ready yet, things are still moving full steam ahead and everyone just wants to be sure it’s safe, effective, and the best it can be. I’ll update everyone on progress when I can, but please know that I’m putting the same passion into this that I do everything else, including the clinic, our research, and advocacy work. Thank you for your support!

Dr Wally
post Posted: Yesterday, 11:58 PM
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In Reply To: bretto32's post @ Yesterday, 04:50 PM

“”the plan (whatever it is)””

The plan is the same now as it was decades ago: a safe, cancer preventative, Scenesse stimulated, EUMelanin photoprotective UVR barrier, skin tan for all.

Ironically while the moronic resistance to safe Scenesse has been dragging on all these years we’ve literally been in the midst of a skin cancer epidemic with no effective treatments only authorities rhetoric promoting sunlight abstinence and constant application of suspect (in multiple areas) sloppy suncreams. It’s a f ing disgrace.

“” In the past decade (2009 – 2019), the number of new invasive melanomacases diagnosed annually increased by 54 percent. An estimated 7,230 people will die of melanoma in 2019. Of those, 4,740 will be men and 2,490 will be women. The vast majority of melanomas are caused by the sun.””

Hold up!

“The mechanism of melanoma is unknown, but is believed to be linked to genetic factors.11 The principal identified non-genetic risk factor is ultraviolet radiation (UVR) exposure, and the relationship between melanoma and UVR is 2-sided: non-burning sun exposure is associated with a reduced risk of melanoma, while sunburns are associated with a doubling of the risk of melanoma.12 It has long been observed that outdoor workers have a lower incidence of melanoma than indoor workers.“”

US regulators let it be known that a “tanning” drug would not be appreciated in clear terms to Epitan/Clinuvel (multiple times) back in the day and that’s why they took off to Europe to see if they could make an impact over there with serious diseases like EPP.

5 plus years later with years of positive data logged from the few lucky enough to have access and still there’s only minimal penetration in a few countries with this utterly safe and life transforming drug. Why?

Is it Clinuvel making an incredible amount of stupid mistakes, asking too high a price for the implant or is it stall tactics and BS from regulators that hate and don’t want to deal with the “tan” factor of Scenesse like NICE that we’re actually caught out being shifty. What they did says so much about the situation.

Why all the “draconian restrictions” and concern about Scenesse? Has somebody suffered a moderate case of nausea again have they ? puke.gif

“”CLINUVEL has had this interest and focus from the start of its program in 2005, however a linear route to proving the thesis was impossible without overcoming **FDA’s resistance to the use of melanocortins as a systemic photoprotective.**

**It is somewhat ironic that the leading regulator had long been most concerned about a hypothesised carcinogenic potential of alpha-MSH analogues, while our teams always had held the opposite view based on scientific data.**

Diametrically opposing the regulators’ view, we actually identified strong arguments in favour of alpha-MSH analogues in general, including SCENESSE® (afamelanotide 16mg)1 potentially being an anti-carcinogenic agent able to slow down, mitigate actinic damage and assist in DNA-repair.””

What’s up with twisting the data around like that?

Now we see the same concern in the US as in Europe, and that’s certain to stifle progress and the rollout in the US even further.

I’m not saying Clinuvel management are faultless but seriously look at all the evidence that shows regulators with their sunlight and tanning biases and fears are the primary cause of what’s holding this company down.

The EPP community need media backing to shame these block headed bureaucrats into action. Their stupidity is keeping the only true remedy for EPP and UVR overexposure and skin cancer in general, from reaching the masses and ending this totally avoidable, costly and devastating skincancer crisis.

Night, night boys!

“” The discovery of the endogenous melanocortin agonists in the 1950s have resulted in sixty years of melanocortin ligand research.””

The never ending quest to have Afamelanotide (peptide) accepted for its potent ability to stimulate a natural photoprotective,cancer preventative, therapeutic “tan” was accomplished in 2019.
post Posted: Yesterday, 05:51 PM
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In Reply To: Dr Wally's post @ Yesterday, 04:11 PM

Bro, I’m sorry to get antsy here but your view about regulators and whoever else and their biased view against afamelanotide because of tanning is looking outdated. The FDA recognised Scenesse as an orphan drug for EPP early on in the piece. The onus was on Clinuvel to prove that they would not go down the tanning path and have done everything in their power to adhere to that principle (to the satisfaction of the EMA and the FDA). How about focusing on what Clinuvel is doing right now? There is no bogeyman anymore, the sole focus should be on how Clinuvel conducts itself and how speedily they can follow trough on their stated objectives (which either continually delayed or were never in progress to begin with and the market was being fed BS to sate our appetites for news and material information. Woe betide the TGA should they cock up in any manner and incur your wrath!🙄

Remember, it was Clinuvel who’s application wasn’t kosher the first time submitted to the FDA and was summarily rejected, of which Clinuvel hid from its shareholders. That kind of behaviour says more about Clinuvel than the rejection does about the FDA. Add to that the growing pile of cash in the bank that is NOT being put to work is adding months if not years to the sp appreciation. Would $30-50 million in the bank sustain current sp levels? Possibly. Would investing that cash in R&D pipeline for expedited development bolster the sp? I have no doubt.

It is my view that you cannot blame others or seek to exlude Clinuvel’s methods of operation for delays and other misfortunes that befall Clinuvel. As fast as I’m concerned the ball is squarely in PWs court from here on in.

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post Posted: Yesterday, 04:50 PM
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In Reply To: Dr Wally's post @ Yesterday, 04:11 PM

I don't disagree with anything you're saying here. But why is it on the regulators to hand it to Clinuvel? Why is clinuvel not proving what their product is capable of and selling it to the world for what it is capable of?

Due to the communication style of the company all we can do is sit back and hope the plan (whatever it is) comes together.

Dr Wally
post Posted: Yesterday, 04:11 PM
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In Reply To: bretto32's post @ Jan 17 2020, 05:09 AM

*** Warning opinion below ***

The seemingly never ending resistance to, and the glacial pace of Scenesse acceptance and roll out, is due to a (incorrect, biased and outdated) fundamental outlook by regulators and health organisations when it comes to sunlight and skin tanning. Note- Scenesse tans the skin.

Good news is the use of Scenesse for EPP and associated diseases over the next couple of years will force a complete transformation in this space from one of fear and ignorance into one of understanding and appreciation of a fully photo protective Scenesse boosted “skin tan”. Until it is understood the old fears will remain and the rollout will continue to be glacial.


“””The risks of inadequate sun exposure have been largely ignored. Recently, however, scientific inquiry has increasingly turned to the benefits of moderate sun exposure and the public health risks of inadequate sun exposure.”””

The risks and benefits of sun exposure 2016.

“”Public health authorities in the United States are recommending that men, women and children reduce their exposure to sunlight, based on concerns that this exposure will promote skin cancer.

On the other hand, data show that increasing numbers of Americans suffer from vitamin D deficiencies and serious health problems caused by insufficient sun exposure.

The body of science concerning the benefits of moderate sun exposure is growing rapidly, and is causing a different perception of sun/UV as it relates to human health. Melanoma and its relationship to sun exposure and sunburn is not adequately addressed in most of the scientific literature.

Reports of favorable health outcomes related to adequate serum 25(OH)D concentration or vitamin D supplementation have been inappropriately merged, so that benefits of sun exposure other than production of vitamin D are not adequately described.

This review of recent studies and their analyses consider the risks and benefits of sun exposure which indicate that insufficient sun exposure is an emerging public health problem. This review considers the studies that have shown a wide range health benefits from sun/UV exposure.

These benefits include among others various types of cancer, cardiovascular disease, Alzheimer disease/dementia, myopia and macular degeneration, diabetes and multiple sclerosis.

The message of sun avoidance must be changed to acceptance of **non-burning** sun exposure sufficient to achieve serum 25(OH)D concentration of 30 ng/mL or higher in the sunny season and the general benefits of UV exposure beyond those of vitamin D.””

Right now a drug that “tans” the skin continues to be just too difficult and contradictory to the decades old tried and true (utterly ineffective) rhetoric that we’ve all grown up with.

Regulators- Better to keep our heads in sand than to bother reeducating ourselves, turning our backs on old scientific theories and rephrasing our old school (photo phobic) slogans PLUS our friends with the billion dollar/year suncream company’s would not be happy.

Good chance they’d stop funding our suncream promoting, sunlight phobic programs that we make a good earn on each year.

The war on sunlight is still as strong as ever in most circles and here lies the true reason why Scenesse still struggles to get ahead.

***Please don’t freak out and do your head in if you can’t see what in saying here, it’s just my opinion***

“” The discovery of the endogenous melanocortin agonists in the 1950s have resulted in sixty years of melanocortin ligand research.””

The never ending quest to have Afamelanotide (peptide) accepted for its potent ability to stimulate a natural photoprotective,cancer preventative, therapeutic “tan” was accomplished in 2019.

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post Posted: Yesterday, 11:33 AM
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In Reply To: LegendInMySpareTime's post @ Jan 17 2020, 09:49 PM

I saw this question posed before. I don't know these stocks well, I buy on gut and emotion. I like PTN for kidney and IBD indications, pipeline. If AMAG has been under-promoting due to financial distress this could be a great thing. If there is a clause in their agreement that makes PTN free because of this, keep the money and find a big pharma suitor, even better. Also a buy and hold, all or nothing guy. 200K shares each of PTN and AVH. I count myself blessed to be in this position. Looking for home runs, willing to take a risk. Melanocortins still untapped and PTN for me is a way to diversify the class.

If Vyleesi sees a label extension to ED treatment, gives me a boner without even taking it!

I let it ride and see what the future brings. Still like the odds. But Avita for Wounds, Vitiligo and Cosmetic applications really excites me. What I didn't realize was the crapload of outstanding shares.

I now enjoy a roughly 500-600% gain is my CLVLY, time to enjoy some of that. Adding a G-Wagon to the fleet in days. None of us are getting outta here alive.

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post Posted: Jan 17 2020, 11:35 PM
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In Reply To: royco's post @ Jan 16 2020, 06:04 PM

How long more Will they allow this rogue outfit to go on? Probably until there is enough public pressure demanding a cancer preventying solution. Cancer associatiions should be fighting this fiight for us but they don't know

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post Posted: Jan 17 2020, 09:49 PM
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In Reply To: PunkassDerm's post @ Jan 17 2020, 02:01 PM

Hey PAD, what's your take on recent developments with PTN/AMAG? PTN still worth a shot in your opinion?

post Posted: Jan 17 2020, 06:21 PM
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In Reply To: polyphemus's post @ Jan 17 2020, 01:01 PM

It was written in obfuscation

Reminded me of my college papers.

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