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endymion96
Posted on: Yesterday, 04:13 PM


Group: Member
Posts: 361

Hope they are friggin' ready by Northern summer ... its only a few months away. Better be.
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endymion96
Posted on: Feb 17 2020, 06:54 AM


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Posts: 361

No that is just first-time users experiencing side-effects. They tend to lessen with use. The reason is too much drug at once. I've said this for years ... these side-effects can be mitigated. If you really want to use Vyleesi correctly without much side-effects, you would first load up with small doses to get your body used to the drug, then use the full amount in auto-injectors. Doing it fresh, having never tried it, is bound to bring these kinds of reactions.
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endymion96
Posted on: Jan 24 2020, 05:07 PM


Group: Member
Posts: 361

I live near Washington DC. Its been a pretty mild winter so far. So I imagine farther south would be even warmer.
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endymion96
Posted on: Jan 6 2020, 07:14 AM


Group: Member
Posts: 361

I am heartbroken to hear the sad news about the fires raging in Australia.I have heard reports that up to half a billion animals have perished in the fire or succumbed to injuries. My deepest sympathies from across the ocean in America.
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endymion96
Posted on: Dec 16 2019, 08:14 AM


Group: Member
Posts: 361

How about this for the final slogan ... "One 'S' to rule them all, Scenesse". Call channel 7 news and put this last nail in the coffin of Skin Cancer.
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endymion96
Posted on: Dec 5 2019, 07:42 AM


Group: Member
Posts: 361

I saw something interesting on the google site that Uhohinc mentioned that he found over here. It was a comment, made by Lachlan Hay, related to either Juxtaposer or Madman before the AGM ... and that was that the Scennese "implant" darkens both light and dark areas of the skin in regard to Vitiligo sufferers. This makes total sense since the implant infers a systemic application of the drug. Lachlan also mentioned that it would be much better to apply a surface topical (i.e. CUV9900) to ONLY the light patched skin of Vitiligo sufferers to achieve the best result. So I have digested this information in regard to the competitor's drug. It too effects systemically as the drug is delivered orally. Therefore, they may not have a winning formula when it comes to the Vitiligo market. As we know, this pool is much larger than EPP. Additionally, Clinuvel is looking to apply CUV9900 to children and babies as it may be a better way to go safety-wise because who knows what effect Scennese would have on growing babies and children under 18 and their budding immune system? So that is very positive news.
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endymion96
Posted on: Dec 4 2019, 04:56 PM


Group: Member
Posts: 361

There is truth to what LH is saying here. During the Clinuvel trials when they were noticing the side-effects of nausea, flushing, headaches, stretching, yawning, etc ... I knew from my experimenting that those side-effects were caused by releasing to high of a dose at one time. If, as I stated here years ago when I was yelling at the company on this board, they lowered the dosage and/or were able to somehow get a slow constant release, those side-effects would not have been as severe or would have disappeared altogether. As it happens, the more the drug is used, the less the side-effects occur. Of course the caveat here is that you are not over-dosing. The only side-effects that I found was the desire to stretch and yawn if the dosing was correct. That said, a pill form may be easier to control dosage. I sincerely hope that its efficacy is not so good so that my investment in Clinuvel remains safe. You guys are being unduly harsh on LH. He is presenting information that rings true with my experimentation, but I have to believe that this pill will not be so effective when all is said and done. My reasoning for this is due to the "lock and key" analogy. Scennese works extremely well because it mimics the natural key in a similar manner. I cannot see any key that isn't similarly formed having the same effectiveness.
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endymion96
Posted on: Dec 4 2019, 04:38 PM


Group: Member
Posts: 361

I can attest that the synthetic variant a-MSH linear peptide is a full agonist. Back in my experimentation days, I performed a crucial test after a few weeks of daily dosing. Normally, if I performed this test sans peptide, I would have become a deep red lobster as I do not tan hardly at all. My test involved heading out to the beach and laying on the sand between the hours of noon to 3pm in July on a sunny summer day. Mind you I did this test without applying any suntan lotion or protection of any kind. The result ... no sunburn at all. Later that evening, I had a developing tan ... which grew darker as the days went on. Now, obviously somebody might think that the tan was the goal. For me, it was not as amazing as the absence of a sunburn. That was the true magic and the reason why I am so frustrated that people like me must wait so damn long to use this drug commercially. I mean, what will it take, another 5 years for me to get my hands on it? The experience was truly life-changing. I can't imagine what EPP sufferers must think. Probably what I thought 10x!!! Now if this MT drug is only partially effective, it seems to me that it would not be my first choice. I have champagne tastes, so only the best, most effective treatment will do for me.
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endymion96
Posted on: Dec 3 2019, 03:06 PM


Group: Member
Posts: 361

If the newsletter was aimed at the retail investor, it was aimed at the unsophisticated retail investor. At the time of the AGM, I thought the info provided was great. DNA repair is the 3rd leg of the stool and upon successful demonstration, we will all have a nice, fat stool to sit on. What was lacking from the AGM presentation and the newsletter was not potential and vision, but concrete timelines for the vision to come to fruition. We have known about this plan for a few years now. The concentric circles diagram gave us the clue. I don't want to be negative, but this is the problem I see in the aftermath of the analysis of FDA approval ... the company is leaving everyone hanging. And as the SP sinks to pre-FDA approval levels, we're all getting paranoid. What would soothe my mind is an actual roadmap from the company.

Before FDA approval, I cut Clinuvel 18 years of slack. I allowed them to keep me behind a veiled curtain of secrecy and put all of my trust in management. Now that they have approval, all I am asking for is a little respect as an investor. If, for some reason, Clinuvel cannot reveal the roadmap just yet, then f-ing say so in the newsletter!!! Clinuvel, if you are reading this, the worst thing you can do to an investor is leave them hanging with their savings on the line (some of us anyway). I am quite sure that many of us might not be feeling this way if the threat of a competitor were not on the horizon. We will find out just how credible this threat may be in a few months ... and we will also find out how distant that threat is (not from Clinuvel but from MT timelines and roadmap). But in the meantime, where are the Clinuvel timelines/roadmap? Am I being too harsh on management or do you think we should know this by now? They have had years to review the phase IV data. They obviously know that DNA repair is already a reality, they just have to demonstrate it. I would think that this game plan was completed at least a year ago and the dominos have been set. If not, why? This is what I want to hear in our newsletter.

Ok, rant over. Serenity now!
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endymion96
Posted on: Dec 2 2019, 06:28 PM


Group: Member
Posts: 361

Go back and read the contents of that link all the way through. There were some interesting court cases where two biotech companies developed a drug for the same indication and the courts ruled both could be approved for use because one drug differed from the other by just one peptide or that one drug was administered once a week and the other daily and that this played a part in the determination that the two drugs were different and could each be approved for the same indication. Soooo, that 7-year exclusivity is not exactly a lock.
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endymion96
Posted on: Dec 1 2019, 05:16 AM


Group: Member
Posts: 361

Please stop the accusations ... its unbecoming. LH is who he has always been, albeit changing his perspective in light of new information. Is it overblown? That is what some of you think, but you are taking your accusations a bit too far. They best we all can do is wait a few months for the competitor's presentation of results and then re-evaluate. I appreciate both sides of the argument. However, this competitor is nothing to take lightly. Management has not yet addressed the topic so it is a normal feeling to be cautious and skeptical. Until we see hard facts and evidence one way or the other, there is no telling.
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endymion96
Posted on: Nov 27 2019, 04:32 PM


Group: Member
Posts: 361

The SP will grow on EPP sales now that we have expanded the market. Unfortunately, we will have to wait until Northern summer, 4-6 months at least. Groundhog day again. Money talks, bs walks. Show me the money! That is the driver for investors and that is the death knell for people shorting this stock. But until then, they will have their way. NASDAQ listing and a pump on DNA Repair and Skin Cancer prevention may also help. The funny thing is, this drug is the real deal. We should not need to pump it. When I found out that there are only 4200 investors in the company, I thought to myself, well that's a problem ... NOBODY knows about what this drug is capable of. This fault lies with management. Now that FDA has cleared the decks, its time to pump the shyte out of the future possibilities. Will they?
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endymion96
Posted on: Nov 27 2019, 07:59 AM


Group: Member
Posts: 361

As far as competitors, Clinuvel has ...

1. First mover status (FDA approved)
2. MC1R stimulation through synthetic peptide variant of natural hormone (implies safe to use)
3. Maximum efficiency due to absorption through the bloodstream
4. Infrequent biodegradable injection (will be about as frequent as getting pill prescription refills)
5. Tons of phase 4 safety data and analysis

That's off the top of my head, if you can think of more please add. So the competitors may have a drug that triggers MC1R, but is it confined to area OUTSIDE the blood-brain barrier. If it is not, they may get more side-effects than they wanted and this may not pass FDA scrutiny. Secondly, pill form delivery may mean less effectiveness. Stomach acid will see to that. But if enough drug passes the stomach and gets to the bloodstream, it may work albeit slowly. We will have to see what effectiveness results from testing. Lastly, they do not have 5+ years of post- prescription, closely monitored, blood panels, liver tests, health data like Clinuvel has. I'm sure the FDA will not be as swayed about safety as they have been provided via Clinuvel's dossier. There is a chance that all this matters and will buy us more time than we think?
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endymion96
Posted on: Nov 20 2019, 02:36 PM


Group: Member
Posts: 361

After reading the AGM report, my take is ... the slow progress of approval was due to previous reluctance of regulators. Timing was everything and it is only now during the last decade that Scenesse would have had a chance at approval. And so it was, approved by the EMA 2014 and FDA 2019. This approval was due to much scientific research and data collected during the trials. Mounting evidence of safety and efficacy could no longer be denied by the regulators and their changing attitudes finally tipped the scales. Because of EMA/FDA approvals, the medical community, covering much of the western world, now acknowledges that the claims of systemic repigmentation and system photoprotection are indeed TRUE and accurrate. Clinuvel now wishes to prove that the third leg of the triangle, systemic DNA repair is also TRUE of this drug. Therefore, it intends to pursue small human trials as soon as possible. Once this is accomplished and the data is analyzed and the expected result is shown to exist, approval (by the regulators) of this final claim will conclude the goal set out by Clinuvel. It will be at this point that they will be able to market Scenesse and its follow-on products as a Skin Cancer preventative.

Apparently, any competition is years away from stealing any sort of market share. What surprises me is the total number of shareholders in Clinuvel, only 4,200. Wow! We are no where near the kind of viral growth I would expect from a biotech holding this kind of life-changing technology and opportunity for the future. I have to conclude that shares are very, very cheap even now. I applaud the vision spelled out in this report. This is the type of information I need to see from the company.
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endymion96
Posted on: Nov 19 2019, 05:02 AM


Group: Member
Posts: 361

If my maths are correct, that is equal to $41.44M US or $60.81M AUS.
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endymion96
Posted on: Nov 18 2019, 04:19 AM


Group: Member
Posts: 361

Maybe the company should appeal then. Their "false" advertising has been proven mostly true. The action of MT-II does indeed tan the skin and improve libido by way of stimulation of the Melanocortin system. These pathways have been approved by the FDA essentially. As for muscle building and improved fitness, the stimulation of the immune system apparently decreases recovery time between gym sessions or so anecdotal evidence from hard-core body builders would seem to suggest. Beg to differ Johnny H, but the manufacture of a small peptide chain such as Scenesse is fairly straightforward. This is not a complex drug compound. The fragility of it comes from breakage if handled improperly or violently mixed with bacteriostatic water. The only result would be less potency. The only danger that one may encounter would be taking a dosage in too large an amount which may result in anaphylactic shock. However, that would be on the user, not the drug. The real danger of blackmarket drugs is knowing whether you are getting an authentic product and not some cheap imitation in which the underground manufacturers may have cut corners to save money. A prime example of this behavior can be seen with groups producing THC vape flavors which have been contaminated and found to cause lung damage in the US.

I believe THIS is the main fear most people have in the blackmarket and the chief reason why approved drugs bought through official channels will always be preferred. The trick for Clinuvel (speaking from a financial point of view only) is to expand the market as much as possible. This will be done by adding medical conditions to the list of effective treatments. The FDA approved Scenesse without conditions. So WHY did Clinuvel offer pharmacovigilance to EPP patients in the US for a minimum of 8 years; essentially placing a roadblock on practitioners who want to prescribe off-label? Can this roadblock be overcome? Interesting question that I do not have an answer for. Will this extraordinary patient monitoring pave the way for wider acceptance and expanded medical need? Is this part of the looooong-game for Clinuvel? Is PW calculating a brilliant strategy that will "pay off in the end"? Or will this loooong drawn-out process only allow for competitors such as Mitsubishi time to catch up and steal the market away from us?
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endymion96
Posted on: Nov 12 2019, 09:51 AM


Group: Member
Posts: 361

No patent issues since it is not a peptide and has a different form of delivery to boot.
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endymion96
Posted on: Nov 12 2019, 06:18 AM


Group: Member
Posts: 361

This will become a major threat ... it all depends on the degree of efficacy. If it works, but not that well ... then we can all breathe a sigh of relief. If it works just as well as Scenesse, then its simply a matter of time until their drug is approved. We all must pay attention to the results which will be released in early 2020 at the scientific congress whatever that is. It will be impactful to our investment.
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endymion96
Posted on: Nov 11 2019, 06:45 AM


Group: Member
Posts: 361

I honestly don't know where I stand. I think my main source of frustration regarding compensation is that one person can absorb so much wealth while loyalty of long term shareholders gets nothing above and beyond what somebody who just bought in a year or three ago is getting. That is upsetting to me. We've been here as long as most in management if not longer. Yeah the SP is higher than its ever been, but 15-20 year holders get what bonus? Nothing. And I have been an ADR holder to boot, no voting rights. Maybe if we got some compensation for our loyalty that would make me not so hot to agree to the deal. Anyway, my voice is muted so this is all just venting. We should be so lucky with our short interest. the vultures over at Palatin average 60% short interest since approval. They've pecked it down to 0.80c US. So far no reverse split, but we shall see. Sales of the product will be coming in next quarter and I expect this to rocket. But with 227mln shares, their future is not going to be as bright at CUV with just 50mln. So, I look at both stocks and say, its not so bad over here.
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endymion96
Posted on: Nov 3 2019, 09:11 AM


Group: Member
Posts: 361

A lot of people have been holding on to this stock for many, many years. I'm not sure where to get the info, but can somebody do a comparison of shareholders to see how many people finally cashed out and are finished with Clinuvel. I bet there were many people who figured they made a nice profit and they dropped off. I suggested that this might be the case over a year ago. So we had pressure coming from this pent up demand to sell and we had shorters jumping on a SP rising catalyst to bring it back down. The good news is that the next rising catalyst may not bring with it such a drastic decline if we've shaken out the shareholders who aren't riding this out to the end ... and by end I mean the next 4 years. But I'd be interested in the comparison of shareholders then vs. now. Another question, did FDA approval bring in new shareholders?
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endymion96
Posted on: Oct 31 2019, 03:55 PM


Group: Member
Posts: 361

Hey PAD, this one is for you!
https://www.yahoo.com/lifestyle/suzanne-som...-221844130.html
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endymion96
Posted on: Oct 28 2019, 07:45 AM


Group: Member
Posts: 361

Right now the shorting action on Clinuvel is coming from CUV shares because there is not enough liquidity in CUVLY or LF to make quick trades (ie, get in, get out) intraday. Swing trading is a different beast though. That may be going on, but you have to time it right. With all the expected catalysts to drive the SP higher, I would not take a chance on this stock. Of course others might ... and that is why most traders can't hack it in the long run. They lose! That is why the fundamentals of a company are your friend over the long run. I do not care about the daily fluctuations because I know where we are headed.
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endymion96
Posted on: Oct 28 2019, 07:23 AM


Group: Member
Posts: 361

They do because they can only afford to lose so much of their portfolio in one day. If they took out a big position in a high-dollar stock and lost it, they would get wiped out in no time. Day traders don't always win. Show me a day trader that wins consistently and I'll show you that they are a very rare breed. Only 10% of day traders are successful over time. Most flame out because they make dumb moves and then try to double-down and win back their losses. Trust me, they stay away from high-dollar stocks because these are dominated by the big boys with HFT algoritms who can afford to throw around big money and take big positions. Day traders stick to medium-cap companies with SP's having high volatility to make their money. The minimum requirement in the US to be considered a day trader by the IRS in US$25,000 (and this balance must be maintained through the year), make at least 4 trades a day, and spend at least 20 hours a week trading. Most good day traders say you need double that, US$50,000 to make a go of it.
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endymion96
Posted on: Oct 27 2019, 09:28 AM


Group: Member
Posts: 361

One thing to keep in mind is ... the higher the SP, the less shorters will be attracted to the stock. The less volatility there is with the SP, the more institutional buyers will be attracted to get involved. The big boys play in the big pools and can afford the risk of paying for high-dollar stocks. I'm assuming that is why the SP of companies do not split until they reach a certain level where even in the split, the resulting SP will not invite too much trouble from shorts.
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endymion96
Posted on: Oct 25 2019, 06:52 AM


Group: Member
Posts: 361

PTN recent fall from grace (above US$1.50) occurred due to 40 million share ATM offering just a day or so after FDA approval. This dumb move by management killed all of the momentum and then shorters came in and drove it down further. SP is holding at resistance level now waiting for Vyleesi sales news to pull it back up and onward. I believe, due to the way AMAG (licensee) is marketing the drug and the education of doctors that must first occur, ramp up will start out slow and then accelerate ...as will sales. So, SP will follow suit. I do not expect this investment to blossom until at least a year of increasing sales has been achieved. But I do believe once the train starts chugging along, it won't be stopped. At any rate, I'm not sure an apples to apples comparison to Clinuvel can be made due to the ATM used to fund PTN future pipeline. Both companies have an FDA approved drug, and both drugs work effectively. I believe the investment in Clinuvel is the better bet right now because Palatin has an effectiveness issue that it must first dispell. Similar to how many people thought Scenesse was not very effective due to incorrect measurement of sunlight exposure during trials, Palatin has the same kind of thing with going on with HSDD measurement effectiveness. The drug works and works well. If they can expand drug to male population, it will explode since males respond much more easily and the measurement (i.e. boner) is not in doubt ... where other drugs like Viagra, etc ... failed to work on some men. Sales of Vyleesi have barely even started. I don't expect any news until early 2020.
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endymion96
Posted on: Oct 24 2019, 02:52 PM


Group: Member
Posts: 361

Unfortunately, this company's SP will never be truly safe from shorting until we have big institutional buy-in and millions more shareholders. There is a threshold where day trader interest declines and that only happens when volatility smooths out. When the hedge funds and instos invest, we will see these shenanigans end. But a NASDAQ listing is necessary step before that happens.
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endymion96
Posted on: Oct 24 2019, 10:10 AM


Group: Member
Posts: 361

Story of my investment life as well. Never have the money to spare to load the account beforehand.
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endymion96
Posted on: Oct 22 2019, 01:15 PM


Group: Member
Posts: 361

I think shorters played a part in the stock price movement, but I also have stated in the past what would happen upon approval. Perhaps a year ago, I predicted that the SP would spike, but it would then pull back by 25% BECAUSE so many of us have been invested in this company for so long that people were bound to exit at this moment. And true to form, some have admitted that they finally sold out or took a solid chunk off the board. This was all to be expected. The fact that we sit at a higher plateau now and that the SP fall seems to have subsided is good. For those who can afford the patience to see this thing played out, count me in your numbers. For those who chose to exit or take some profits, man I wish I had as many shares as you guys and gals. Hopefully, my ride or die strategy will eventually get me a ticket into the big leagues someday. Unfortunately, I am one of those who will have to endure more "time" to reach my goals. I wish I could quit my day job and go into semi-retirement, but that is not my path. My hope is we will all make it to see that grand party on Bondi Beach someday ... and that this drug treats numerous more diseases and people than we ever could have imagined. I will know my goal will have been reached when I can go to my doctor and get that first script. Until then, cheers to all for each hopeful, informative, venting, chiding, blue sky post. I am with you! Billy Boots especially.
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endymion96
Posted on: Oct 9 2019, 03:07 PM


Group: Member
Posts: 361

You know what? The US market has not yet had a crack at this due to the trading halt. So, several hours from now, we will see if the FDA news has travelled across the country and whose big pockets are ready to gobble up some CUVLY. Should be another blockbuster day. At the very least, most can be assured that SP is locked in at a nice level of support from here on out.
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endymion96
Posted on: Oct 9 2019, 10:22 AM


Group: Member
Posts: 361

I wonder if there will be more institutional buy-in now to buoy the price at these higher values now that risk is off the table? Something to keep an eye on.
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endymion96
Posted on: Oct 9 2019, 06:33 AM


Group: Member
Posts: 361

Dumb investors who shorted this stock. Did they do any due diligence? Odds of approval were extremely high, especially with Vyleesi approval a few months earlier and only known deficiencies in dossier submittal easily correctable.
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endymion96
Posted on: Oct 9 2019, 06:04 AM


Group: Member
Posts: 361

Their excuse is a health care system that rations care based on cost ... they tried to hide that fact by basing their decision based on supposed effectiveness when they knew the trials were flawed and patient feedback said otherwise. Now they are boxed into a corner I would think.
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endymion96
Posted on: Oct 9 2019, 05:08 AM


Group: Member
Posts: 361

Go to lunch, not expecting any news ... and look what happens!!! I've been an owner of this company since 2004 ... back when 2006 was supposed to be the celebration year that Epitan got this drug approved. I found out about the company because I was researching a way to protect myself from extreme sunburn. Of course, after doing the requisite research I learned that I'm just one of those people who cannot tan due to a genetic defect on my melanocyte receptors. This drug provided hope for me in that respect, but it will now provide treatments for others with worse conditions as well. As they say, I'm not only a buyer, I'm also (hopefully) a user of this wonder drug. Cheers to all of you who have weathered this storm together with me. Its been such a long road ... we can finally take a little break and rest a little easier.
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endymion96
Posted on: Oct 7 2019, 01:27 PM


Group: Member
Posts: 361

I just want a nice pool in my backyard. On Night's Watch tonight ... listening to early David Bowie circa 1973. Shorts will scatter come morning time. I'd be surprised if this was not the case. Nothing else to offer but champagne wishes and caviar dreams! And finally, some relief to all sufferers whom this drug shall soon treat.
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endymion96
Posted on: Oct 5 2019, 01:56 AM


Group: Member
Posts: 361

I plan to drink heavily this wknd.
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endymion96
Posted on: Sep 30 2019, 11:16 AM


Group: Member
Posts: 361

Your modest parcel is more than I own. I wish I had more money to invest back then. As it was, I was taking out loans on my credit card to get what I now have. Its been a long road, I'm not selling until we hit $80.
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endymion96
Posted on: Sep 26 2019, 02:56 AM


Group: Member
Posts: 361

So do we think the shorts are going to hold through the FDA approval decision or will they break a day or two before? If they hold, are we to believe that their modeling says to them that the probability of a negative outcome is greater than the probability for approval? I mean, lol. What evidence do they have for that? If none, then short action should break very shortly unless they have no clue about the sh*t storm coming their way. I cannot fathom shorting to this degree at this moment in time with this company. Can somebody explain their logic?
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endymion96
Posted on: Sep 16 2019, 12:37 PM


Group: Member
Posts: 361

New dealer coming in, place your bets. Will the shorts get burned on early approval? Will the FDA fast-track this puppy on its last hand-off to the anchor runner? Or will history repeat and maintain status quo?
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endymion96
Posted on: Sep 5 2019, 01:23 PM


Group: Member
Posts: 361

Tick, tock, tick, tock, tick, tock ... well we got through August. Now for the agonizing grind towards the finish line ... brutal. Several bottles of Syrah and/or Jamison at the ready.
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endymion96
Posted on: Aug 17 2019, 10:21 AM


Group: Member
Posts: 361

I agree with that conclusion. This study bolsters the case even more that Scenesse will be approved. Firstly, because efficacy is not in doubt, secondly because EMA already approved it, and thirdly, because the FDA has had 4 years of additional data to review.

Tom Petty once wrote a song ...

The waiting is the hardest part
Every day you see one more card
You take it on faith, you take it to the heart
The waiting is the hardest part
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endymion96
Posted on: Aug 8 2019, 12:17 PM


Group: Member
Posts: 361

Also ... I forgot, company insiders bought more stock.
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endymion96
Posted on: Aug 8 2019, 11:48 AM


Group: Member
Posts: 361

PTN surged 20% ahead of the AMAG Q2 financial earnings results. AMAG is the company that bought the rights to market Vyleesi in North America. When the transcripts were released the next day and the results weren't so good, the SP dropped back down. Not sure why there was such huge optimism for Q2, its Q3 that counts because that is when Vyleesi sales start ... in September.
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endymion96
Posted on: Jul 24 2019, 10:45 AM


Group: Member
Posts: 361

I think the main area of concern was due to synthetic aMSH contributing to skin cancer ... at least that was the fear originally. I mean, its in the name "Melanocyte Stimulating Hormone". As years of research and real-world data piled up, this fear has been demonstrated to be unfounded. This is why I believe the FDA has absolutely no problems with the safety profile and will not restrict usage. Off-label prescription is a possibility.
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endymion96
Posted on: Jul 22 2019, 01:48 PM


Group: Member
Posts: 361

And eventually skin-cancer prevention! It is a mind-job on when to sell isn't it? Basically FOMO should keep the SP at great heights. The shorters of this company just don't have a clue about its potential and for that, they will get burned.
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endymion96
Posted on: Jul 22 2019, 01:21 AM


Group: Member
Posts: 361

Of the 48mil shares, do you know the percentage owned by Australians vs. US vs. Europeans vs. Asia vs. rest of world?
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endymion96
Posted on: Jul 21 2019, 06:38 AM


Group: Member
Posts: 361

True, but we could have said that every summer for 5 years now.
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endymion96
Posted on: Jul 20 2019, 10:43 AM


Group: Member
Posts: 361

This delay until October may be a blessing in disguise. If the FDA had approved Scenesse in early July, it would have been a terrible time to make in introduction to the US market. Summer is typically a very slow time when people are off on vacations and holidays. However, it is a great time to buy stocks on the cheap. On the other hand, the planned early October approval date will provide MAXIMUM momentum to the share price as investors will be in full motion looking for good deals. Its like timing when a big blockbuster movie will come out ... this is ours!
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endymion96
Posted on: Jul 18 2019, 03:46 PM


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Posts: 361

I'm not selling one share. I've always been ride or die with this company. I learned my lesson that when you try to time the waves for a few pennies, you end up missing the big one that takes you all the way home.
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endymion96
Posted on: Jul 18 2019, 01:42 AM


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New article on SeekingAlpha about Clinuvel. Article is negative about future prospects, but I don't believe it is well researched and taking into account all aspects. I can't figure out how to get the URL, but the title is "Clinuvel: Bubbling And Ready To Burst". Author believes current SP is a bubble and company is not worth investing in at this point. I have too much to say about that, but have to get to work right now.
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endymion96
Posted on: Jul 15 2019, 08:55 AM


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Bookmarked!
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endymion96
Posted on: Jul 11 2019, 01:37 PM


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I'm fairly certain you are on target here. I doubt the FDA has plans to monitor after approval. This is probably why they need to be very cautious with the labeling and manufacturing and hence the delay. 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'm surprised something more concrete was not applied. I guess Clinuvel is not privy to those communications; however, I am encouraged by the rest of the newsletter. These are the kinds of newsletters I like to see. Its taken years to be as forthcoming as it should have been all along, but I'll take it late than never. Everything appears to be going to plan and the future is looking fantastic.
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endymion96
Posted on: Jul 10 2019, 01:27 PM


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The reason I have been bringing up Palatin in relation to Clinuvel is for several reasons. Firstly, they are not a one drug company. Palatin has several drugs in the pipeline that work through the MC1-R receptor. This means they might possibly be a competitor even though their drugs are targeting specific diseases and medical conditions for which Clinuvel is not. Their business model is centered around the cyclic form of a-MSH whereas Clinuvel's is the linear form. In the US, off-label prescription is not uncommon. Another reason for comparison is management styles. Their management is much more forthcoming with information, but also has made some mistakes. People can learn from these mistakes and hopefully recognize certain moves by mgmt which may help them with their investments here. Also, we can also gauge the public's appetite for a new class of drug of which Vyleesi is the first melanocortin over the finish line. I don't think safety was an issue at all with PT-141. What is was ... was, as I have been shouting from the rooftops for years, a problem of dosing. PT-141 was rejected by the FDA because Palatin originally administered their drug nasally. From my research and experimentation, this meant too much drug too fast and bam, problems!!! So what they did was go back to the drawing board and repackage the same drug, but administer it sub-Q which is a slower process. It still has problems of being a bit much for some, but you can't go sticking yourself several times over the course of several hours to get the effect you are looking for as that would be impractical. So it all comes in one dose. This is why some minority of people will get nauseous or develop a heat flash with Vyleesi. Clinuvel has the lock on the slow-release administration method which makes it much more tolerable, but both drugs are safe and very specific and thus have an advantage over other drugs which are trying to accomplish similar outcomes. For instance, Palatin has a drug in the pipeline that will compete with Humira, Ozurdex, steroids, and others, but is much safer having much less contraindications. Treating diseases with peptides is a relatively new area of research. So it makes sense to follow related companies especially since Palatin and Clinuvel will be competing in the DNA repair and anti-inflammatory areas. What I am not sure of is how much overlap there is between the two companies and where the line is regarding infringement on patents. For instance, Palatin has developed an MC1-R drug that can be taken orally for inflammatory bowel disease. They have demonstrated that their peptide makes it past the stomach and into the intestines where it has direct action on the receptors. Could Clinuvel potentially do the same? Why is Vyleesi administered sub-Q and not slow-release? Are their patent infringements which prevent one from the other? So that is some of the reasons why I highlight this company. Could the two companies perhaps merge in the future? Many questions. Also, I think literally nothing will happen between now and the FDA decision on Scenesse in October, so I think some new lines of discussion can cure some of the boredom while we wait.
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endymion96
Posted on: Jul 9 2019, 07:40 AM


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Fun fact: I chose the bananna as my avatar years ago for one reason only. Who wants to know why? Its because Clinuvel kept slipping their schedules on us. <snare hit, cymbal crash> and laughter ensues ...
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endymion96
Posted on: Jul 9 2019, 02:07 AM


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If you need a new high while you wait, you can always join the fun over at Palatin. FDA approved drug over here, though management gaffed and issued 40 mil new shares a day after approval. Shorters had a field day (and still are). I got in super cheap as anyone can now at $1. But let me tell all you Cinuvel longs something, I really appreciate how stubborn and patient you all have been. For myself, I have been in this stock for 15+ years. I only recently took up a stake in PTN. However, the contrast in stockholders is striking. I amuse myself by reading the posts on the stocktwits board. The patience many of these posters display is that of an amnesiac who has ADD. They are bitching about the stock not going up within several months of buying in, much less a year. The "longs" over there maybe have been in for 2-3 years. We strong hands of CUV and CLVLY spit at that and fart in their general direction. The many weak hands of PTN say they will get out with 0.20 cents profit when the SP goes back up and they will wash their hands. This is why the SP is hovering at the dollar mark right now. Hahahaha ... I mean really? The sales of Vyleesi don't start until September and they can't even wait 2-3 months. I think Clinuvel management should give all of us medals, we're practically saints of patience.
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endymion96
Posted on: Jul 8 2019, 02:59 AM


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Did you see the other lecture mentioned, "The role of DNA damage repair and transcriptive stress in aging and the impact of nutrition"? If DNA damage repair slows down aging, eating fruits and veggies ain't got nothing on Scenesse!
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endymion96
Posted on: Jul 5 2019, 01:58 PM


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FWIW, Vyleesi did not require an advisory committee either. Stated reason by FDA was no safety concerns or efficacy issues requiring outside expertise. You can read about it in their approval letter and commentary in this news article.

https://www.buzzfeednews.com/article/danver...-women-approved
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endymion96
Posted on: Jul 1 2019, 03:11 PM


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Imagine taking a spoonful of Scenesse or popping a tablet? It might happen in the future. Check out this article describing the breakthrough discovery.

https://www.sciencedaily.com/releases/2018/...80221122406.htm
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endymion96
Posted on: Jun 27 2019, 11:33 AM


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Posts: 361

As we bide our time over here, I checked in on the strangeness over in PTN land. So the first melanocortin drug gains the all-powerful and nearly unattainable FDA approval and the SP goes down? Why, I wondered? So I started reading over on the stocktwits board. Apparently, the company issued 40 mil new shares right after approval and then promptly the company execs and insiders bought cheaply on the dip erasing shareholders expected profits, but securing the company's financing for the future pipeline development of 4 new drugs in development. So the result, 100 mil in the bank to fund the pipeline, insiders are fat and happy, institutions are able to buy in cheap now derisked, and weak hands and some long-time shareholders are selling their shares in frustration. But, the future for that company looks very bright. Moral of the story? You have to be wise to the ways of the masters at the top of the pyramid. If you don't know the games and how they are played, you might just sell all your shares in a fit of rage and lose out on the huge profits the wizards of wallstreet leave for the rest of us. The best play for the peons that got in recently (circa 1-2 months ago) would be to average down on shares right now, not sell out. Its fun to watch the game when you are not too invested. Since I got in (hopefully at bottom), I am going to enjoy the ride up. Still, patience is required. As we all know, "in the end, it will pay off"!
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endymion96
Posted on: Jun 25 2019, 09:49 AM


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Sloppy research too or ... might be paid to "omit" a potential treatment/cure by a competitor aka Clinuvel.
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endymion96
Posted on: Jun 25 2019, 06:12 AM


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Yes, I could see that point of view, but it sounded like he didn't know. If he knew, it would have been brilliant insight for him to explain it. While this drawback is a valid point of contention, the delivery mechanism can be overcome. Palatin has an approved melanocorin drug on the market, that is what counts as far as the pure investment is concerned. Sales will come eventually, especially with other medical conditions they are looking to treat or cure. Clinuvel has and is the same prop bet except it effects a different MCR.
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endymion96
Posted on: Jun 25 2019, 04:03 AM


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If he does not know why the drug is an injectable vs. a pill, he hasn't done his research and nobody should be taking his stock advice. OMG, this guy.
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endymion96
Posted on: Jun 25 2019, 01:57 AM


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In the absence of negative news on Vyleesi, I have to attribute this to profit-taking by long suffering shareholders. I bought more on the dip. Approval of Vyleesi is great news for Clinuvel and its melanocortin drug. I can't believe the shorters dared to short CUV so harshly last Friday. I have to think they believed Vyleesi would fail to meet approval and thus affect Clinuvel's stock price negatively? Since that did not happen, they should be afraid of the short-squeeze at this point.
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endymion96
Posted on: Jun 23 2019, 04:48 AM


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You are a risk-taker after my own heart PAD! Congrats on having the stones to go all-in. Let me know what date you will set for the yacht party next summer. As for a dude version of Vyleesi, why do they need a dude version? Wouldn't it be the same thing? Is it just marketing? I don't know how stimulation of MC4 affects females, but I do know from first-hand experience that MT-2 worked like gangbusters for me, bloodflow increase and the effect, "strong like bull". I tried viagra once just to see what it would do ... it gave me a heat flush so bad, I stopped using it. That's why I bought some shares of PTN as well. Some people are looking at the treatment of HSDD and the projected sales to come as minor. Who knows? The other drug on the market had poor sales so if that is all it was good for, they might be right about their cautiousness. However, back in my experimentation days, I already knew of Vyleesi's potential to rival viagra and actually overcome the side effect that I experienced. The nausea thing is due to injecting too high a dose all at once. I have been saying for years that this side effect was easy to overcome by taking lesser dose more frequently, but I guess that would be impractical if your only method was Sub-Q. That is why Clinuvel has an advantage. They locked up the slow-release administration method and topicals with their patents. Although I'm not sure if that would apply to other melanocortin drugs or just those that affect MCR-1? Anybody know?
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endymion96
Posted on: Jun 19 2019, 02:10 PM


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CLVLY volume today at 30.34k is about 10x normal. This rocket has achieved lift-off, USA has taken notice.
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endymion96
Posted on: Jun 10 2019, 07:36 AM


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Posts: 361

I actually like the "Frilly" text on the front with the graphic. I would move the more lengthy wording to the back of the Tee. Why? Well, people would see Friily w/graphic and ask, what's that all about? Then you turn around and show them the Clinuvel, the stock tickers, Scenesse, the amino-acid formulation, and a brief text of what it is/does ... world's first photo-protective synthetic hormone? Something like that, listing all the great qualities, anti-inflammatory, etc ...
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endymion96
Posted on: Jun 6 2019, 04:10 PM


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For me its not greed. Its being paid for not blowing my brains out after 15 years of waiting. Its also because I think this is a wonder drug that will help millions, not just EPP population. Its untapped potential. Three months is ok I guess, just wait a little longer and keep the pot boiling in anticipation. Hey, one of you high rollers wanna throw a yacht party when this is done? Unfortunately, I did not invest enough for a yacht, but Ill gladly come aboard and throw a few bottles of Champs around.
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endymion96
Posted on: Jun 5 2019, 06:04 AM


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As RabbitRun concluded, it will be illuminating to keep our eyes on PTN and see what happens there. If, for some reason, there is no delay and their drug gets approval, that may mean it was only CMC issues with Clinuvel and signs would indicate approval is almost guaranteed and will be forthcoming in October. If PTN is also delayed, then we could assume the FDA really is slammed and understaffed or behind. If PTN is not delayed, but rejected that should not be to worrisome for CUV because Scennesse does not pass the BBB and has excellent safety ... we would just have to wait for the decision in October (that would be the worst case scenario). To me, what the FDA does with PTN (in just a few short weeks) will speak volumes about the chances of Clinuvel. I would not be selling right now hoping to buy back cheaper because PTN could slap the writing on the wall as to what to expect with CUV. Anybody who gets out now may get caught with their pants down if PTN is approved. Plus the ASX200 listing, plus a NASDAQ listing all before October. I'm on pins and needles with what is just around the corner ... the PTN decision is targeted for 23 JUN 2019. Hold onto your hats!!!
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endymion96
Posted on: Jun 4 2019, 05:17 AM


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Posts: 361

I tend to think the delay is good news for the SP. In my mind, the ASX200 inclusion was set too closely to the FDA "assumed" approval date. Now that it will be spread out, this will allow a further opportunity for the CINUVEL story to spread and the SP to rise beyond where I think it would have landed. If we can couple this delay with a NASDAQ listing, even better ... actually much, much better. If the company can get their story out to American investors through a NASDAQ listing, you will see alot more people buying the ADR CLYLY on the run up to a listing, so I would keep an eye on volume there.

As for Dr. Wally's notion that all the big Sun Screen companies are dreading the approval of Scennesse, I wonder if there isn't some truth to that and I wonder if it is somehow impacting the FDA decision to delay. Makes you go, hmmmmm???
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endymion96
Posted on: May 29 2019, 12:50 PM


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All that shorting pressure and they still can't contain the rise? I'm sure people noticed the CLVLY volume. Its 7x times normal. This next month will be a very interesting time.
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endymion96
Posted on: May 13 2019, 04:19 PM


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Is this a Game of Thrones reference? I like it ... "Approval is coming"!!!
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endymion96
Posted on: May 4 2019, 01:47 PM


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I think most of the commentary is directed toward getting the manufacturing procedures nailed down and could be chalked up to software configuration issues. Either the procedures weren't captured properly or the software didn't have all the capabilities that the reviewers were looking for at the time. However, looking over the white paper, it seems the openLab software can address most of the problems discovered in the report. For example, the user roles and permissions problem ... on p. 10 of the white paper, it talks about a "Users" module which should take care of the problem. "The Users module enables simplified user management including definitions of roles and permissions". So it appears that the documentation provided by Clinuvel did not address setting up roles and permissions and needed to be updated because clearly the software can handle this type of thing. I believe audit trails could also be handled via the reports module and it looks like you could login remotely and securely view the data/logs as well from other stuff I was reading. The second link (software admininstration) talks about Instrument management/status and also activity logs on p.44. I think its basically just a matter of learning the software and documenting the procedures that they've missed.

http://hpst.cz/sites/default/files/attachm...-9120en-eln.pdf

http://www.ingenieria-analitica.com/downlo...inistrators.pdf
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endymion96
Posted on: Apr 30 2019, 02:03 PM


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I live about an hour from the FDA. Do you think Dr. Woodcock would let slip any info if I casually ran into her in the cafeteria by accident? lol. I think chances of an early decision are good considering that NH summer is only one month away. Why waste time when people are suffering? Shorts will rue the day, but thanks for letting me top off.
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endymion96
Posted on: Apr 27 2019, 04:45 AM


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Posts: 361

Anybody wanna take a guess why there is so much shorting on Clinuvel stock over the last several weeks? Do you think these people have no clue about the potential of Clinuvel and the impending FDA decision and just smell blood in the water? Day-traders? At some point in the coming weeks, the shorts will let up because they will inevitably lose. I wonder if they are aware of this? The FDA approval will be the launch point for all the other goals that Clinuvel execs want to accomplish. This one event will be the cataylst for all that is to come.
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endymion96
Posted on: Apr 27 2019, 01:53 AM


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I'd like to thank the shorters for allowing me one last grab for the ring. P.S. I almost said "punch at the clown" but thought better of it. At any rate, thanks!
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endymion96
Posted on: Apr 23 2019, 04:00 PM


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PD, I'm thinking NICE will have egg on their faces if FDA approves and Clinuvel expands their list of positive benefits of the drug to include what we know it does (i.e. DNA repair, etc.) for other diseases. They will look a bit silly to have rejected such a novel and miraculous drug.
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endymion96
Posted on: Apr 23 2019, 03:54 PM


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Does anybody know if the FDA has required a registry for other drugs? What are the implications if they do not require one? Does that mean off-label usage is a foregone conclusion and perhaps a much wider market than we think will spring up?
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endymion96
Posted on: Apr 23 2019, 03:45 PM


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G dawg, there was nothing ever terrible about it and the drug was never dodgy at all. The simple fact is ... under the then formulation of the drug it just had too many side effects. It gave you a tan, it increased your libido, it suppressed your appetite, etc. It did all this because the structure of the amino-acid chain was small enough to pass through the blood-brain barrier (bbb). Therefore, it activated more than just the MC-1R pathway to include the MC-3R, MC-4R, and MC-5R if I remember correctly. This is why it had so many side-effects. The FDA said, "nah bro, ain't gonna pass like that". They also said sunburn prevention was not a medical condition worthy of approval ... and they definitely did not want to approve a "tanning" drug and attach their name to it. But in my opinion, what the hell was wrong with all those side-effects? I'd take every one of them, lol. Eventually, the chemists found a way to silo the side-effects by tweaking the structure of the drug. Epitan regrouped as Clinuvel and refactored the drug to a straight amino-acid chain which was different from the original and too large to pass through the bbb. Therfore, it only had the obvious tanning side-effect without the others because it mainly activated the MC-1R. Of course it still retains all the really great properties of DNA repair and free radical scavenging, etc ... because that's what happens when the MC-1R is triggered, lucky for us shareholders. Palatin, on the other hand, took their formulation in the other direction and concentrated on the libido enhancement aspects. However, because their drug passes the bbb, they have more complications and may have a harder time getting FDA approval for their drug. But we shall see ...
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endymion96
Posted on: Apr 8 2019, 04:03 PM


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I'm thinking 19.00 USD is fairly cheap for Clinuvel after looking at RYTM, no?
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endymion96
Posted on: Apr 6 2019, 12:12 PM


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Frilly til' I'm silly.
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endymion96
Posted on: Mar 28 2019, 01:46 PM


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Can I play devil's advocate with the SP predictions? The volume for CUVLY is anemic. I would think that if US investors were aware of the pending FDA approval, they would be bidding up the stock right now and volumes would be greater than 10k avg per day. So that is not happeneing ... yet? What makes people think that it will? I mean, I hope it will but I just don't know. We should want a NASDAQ listing first way ahead of approval to make the SP rise as we all agree it should (ie company is undervalued). What I'm saying is NASDAQ listing gives the company visibility. If the NASDAQ listing comes near approval, I'm not sure the SP will bump that much post-approval. Therefore, I think the SP will be bid up by investors in the Aussie market, not the US unfortunately. If that prediction is true, then the question is will US investors buy into a drug after the pop of approval is done? They may in the future, but it could be slow progress here as well.
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endymion96
Posted on: Feb 21 2019, 06:19 AM


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Posts: 361

I believe it will continue onwards and upwards, but I did sell 2000 shares just to get my original investment back. All the rest is house money and I'm letting it all ride. However, there is a twinge of pain on what those 2000 shares might do in the future and what I might have lost out on. Its kinda like the guy who bought a pizza with 100 bitcoins back in the day, d'oh! This is what years of holding have done to me ... and years of watching the prior track record of the SP. I should have known better but played it conservative. I'll still make out very well in the end though.
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endymion96
Posted on: Feb 20 2019, 06:46 AM


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Does everybody think the SP is only going up from here? Does anybody think it will drop at all before the FDA decision?
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endymion96
Posted on: Oct 11 2018, 08:26 AM


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My guess is it is all based on high cost of the drug. Socialized medicine leads to rationing. I would bet that their cost to benefit analysis skewed the panel's decision. Using the unorthodox measure of effectiveness was simply a way to mask their true feelings and show them not as monsters for rejecting the drug, but instead as concerned and meticulous judges using the guise of effectiveness as cover.
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endymion96
Posted on: Sep 29 2018, 01:38 PM


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I might sell 1/3 to 1/2 my shares post-approval at the peak mania spike so I can buy a nice house and hang onto the other 2/3 or 1/2 for the duration while they explore new avenues in the next decade. Hitting the spike should be a fun game.
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endymion96
Posted on: Sep 27 2018, 12:40 PM


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Posts: 361

I will make a statement based on my experience of being long this company since the Epitan days. The SP will hold its value because its base is made up of all the long-timers. The new kids are just now getting in. They will not be selling at any value less than what they purchased (most anyway). So the SP will hold here as the lowest base of support and will be shooting up. If mania takes hold, it may spike. My target for the tip of the spike is +40. It could drop from there 25% but will steadily climb even higher if Clinuvel follows through on their long-term goals. It will be interesting to see how the players in this forum play the game from here on out. Can't wait for that celebration party we'll be having someday. Good hunting!
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endymion96
Posted on: Aug 28 2018, 03:19 PM


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Not everybody in the US is on Medicaid. In fact, most people try to avoid it and find free market alternatives. With the lynch pin being pulled out from DemocratCare via last year's vote on the tax system overhaul (i.e. no more tax penalties for skipping it) most payments would probably be dependent on the insurance companies prerogatives.
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endymion96
Posted on: Jun 25 2018, 04:53 PM


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Wouldn't the opposite of Ignoramus be Intelligensus?
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endymion96
Posted on: May 13 2018, 04:09 PM


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15k cuvly
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endymion96
Posted on: May 6 2018, 10:25 AM


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Maybe I missed the memo, but what is the significance of the cosmetic line rollout? I thought this was a pharma company? Is the product non-drug related? What is it?
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endymion96
Posted on: Mar 17 2018, 04:14 PM


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Yes to all of that. Now if they could just rework that brand logo ...
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endymion96
Posted on: Feb 23 2018, 01:16 PM


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The new logo should be a defibrillator. Guys, it really sucks. I'd like to know what was wrong with Frilly? That was distinctive branding. Ok maybe you don't wanna associate a lizard with skin care, but maybe you take that frilly part of the lizard and put a capital C in place of the head? Keep it simple. With the head gone you no longer have the "reptile" per se, but you keep his cape to imply protection and the Aussie connection. Moon thing is rediculous. Drug offers protection from the sun, not moon. Throw some sun rays around the frilly necked capital C and you got a winner logo.
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endymion96
Posted on: Jan 30 2018, 05:44 AM


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I would say that Dr. Agersborg's appointment was meant to keep it all in the family. Confirms my assumption that PW wants to steer this company away from any takeovers and into the stratosphere as a future big time Australian pharma. The phrase "new territories" is key.
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endymion96
Posted on: Jan 21 2018, 01:47 PM


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After all these years without a change in style or pattern, I think PW's non-communication with shareholders must be on purpose. So then the question is why? My guess is that he wants to fly the company under the radar to escape a potential takeover. He will not settle for peanuts. He wants to turn this company into a full-fledged Austalian pharma. And how is he going to do that? He is going to leverage synthetic-MSH into all sorts of areas as witnessed by the many studies we've seen. It may take another 5 years to get there, but the payoff is obvious. We will start seeing results in 2 years, maybe less depending when FDA approval is given.
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endymion96
Posted on: Dec 21 2017, 02:38 PM


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I wonder how much the rationing of healthcare and the ability to pay with limited funds comes into play in the NICE decision? I wonder if these regulators, without knowledge of the EPP sufferers and lifestyle choices, simple say, "hey they can cover up and shelter at home and they will be ok. We can't approve this, we've got bigger fish to fry"? It may actually work out that their negative outlook might actually work in favor of the drug and the FDA decision. The FDA might look at the safety data and the efficacy of the drug and say, "this one has a better track record than most of the stuff we approve, let's do it. Also, politically it would demonstrate our leadership by going against an obviously flawed reasoning by NICE. Let's give them a black eye on our announcement of approval." One can hope. If there is a political angle in these competing health organizations, I could see this play out.
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endymion96
Posted on: Dec 10 2017, 07:48 AM


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Unfortunately we have to wait at least another year or two before our patience and sanity will be relieved. The good news is ... the extremely long track record of safety of this drug is a cold, hard fact. Efficacy was never in doubt. Twelve or thirteen years ago, I knew of its efficacy through self-trials and wrote extensively about it on an old website some of you may know. Side- effects were known (i.e., headaches, sniffles, muscle weakness, etc ...) and those effects were the result of over-dosage. The key was slow-release. When a report from Clinuvel came out several years later listing these side-effects from trial participants, I was livid because it was known to me years before that you cannot administer all at once and that Clinuvel's slow-release product was not slow enough. I suspect and hope that this issue has been sorted out by now and perhaps is now incorporated as part of the final product. In the years following, we've all read about new research and the possibilities of this drug to not only treat light-related skin conditions and diseases, but far more. Clinuvel may ultimately have its hands on a life-altering drug that treats far more conditions and diseases than we can imagine ... noting that most of the discussions on this board, that I've seen, have to do with the small population on EPP sufferers and perhaps Vitiligo concerns, I suggest that it is only a matter of time that the mainstream wakes up to the possibilities of melanocortin stimulation. So with that, I offer this ... to bide your time as you wait for this glacier to melt ... I foresee this "other" research gaining traction and notoriety in the coming few years. What this means for us investors is a giant slow-building ramp of press coverage and interest in the company. By the time this thing actually pays off, it will have so much pressure built up that it may explode, nuclear style. With that I bid you adue for now.
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endymion96
Posted on: Nov 28 2017, 01:51 PM


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The funny thing is Clinuvel's mgmt is probably older than most of us. You'd think they would want to get the show on the road sooner so they might enjoy the fruits of their work? Maybe these regulators really do slow time down to a crawl? However, I did read that bit in the report about making sure the "Group" or senior staff were well paid in order to ensure the greatest level of effort and consistency, or whatever ... does it really take 15-20 years to cash in on an investment? Well, I'm still in my capsule on the way to Mars. Going back to hyper sleep.
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endymion96
Posted on: Sep 21 2017, 04:22 PM


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A little ZEST is good from time to time. Funniest thing I read all day! Lol
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endymion96
Posted on: Aug 8 2017, 10:13 AM


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Thanks! I appreciate the info.
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endymion96
Posted on: Aug 2 2017, 03:11 PM


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Hi all,

It's been awhile, remember I've been in hyper-sleep waiting for this drug and this company to land on Mars. I see we've still got a ways to go. Who can tell me when the major patents expire?
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endymion96
Posted on: Jan 17 2017, 03:48 AM


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My first post in a long while. Woke up from hibernation to Mars. Disappointed to see we're still a ways off. Anyway, enjoy the article!

https://www.lewrockwell.com/political-theatre/fda-rip/
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endymion96
Posted on: Sep 1 2016, 01:23 PM


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Slow-release is the ONLY method that would ever work. Back in my experimentation days, the slower and lower you went, the less side effects you had. In my opinion, even the delivery rate they have now is too fast. If they could slow it down even further and create a more constant dosage level while doing so, that would be "game over" or at least better for the end user in terms of lessening side effects to the point of zero.
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endymion96
Posted on: May 24 2016, 03:55 PM


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No, it's not that. It's because there are many sue-happy people looking for mega-bucks. FDA has to always make sure it's i's are dotted and t's crossed.
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endymion96
Posted on: Feb 28 2016, 06:22 PM


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HAL, have we landed on Mars yet? Ok, back to the chronos-chamber. Wake me when we're close please.
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endymion96
Posted on: Jun 5 2015, 12:25 PM


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I have been in hibernation. Anything happening? No? Ok, back to sleep. Its a long ride to Mars. HAL, please turn down the lights.
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endymion96
Posted on: Feb 15 2015, 04:09 AM


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The tanning thing will never happen. I've resigned myself to that. Would not even discuss that aspect unless and until a skin cream is researched and targeted for development. So for now, I will keep my feet in reality and try to steer the ship towards wider market applications. And yet, management has not given us much hope that there is any other possibity except for Vitiligo. Why? They have the research in front of them as easily as I can find it.

What I am looking for is a statement from them saying ... at the moment and in the near future we are developing the drug for the treatment and cure of Vitiligo; however, with current advances in science, we have evidence of future treatments for the following diseases and we expect to head toward that direction as soon as revenues dictate.
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endymion96
Posted on: Feb 9 2015, 04:28 AM


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Yes, of course ... these things will take time and money. But my point is ... get the word out that you have the patent rights and that you WILL be pursuing this direction in the near future once significant revenues allow. Has this been said? No. Why? Do they not have the patent rights? If they do, then why wouldn't you let it be know that you hold an approved drug with potential to change the world? This is easily backed up by research reports of the last 10 years. I can site several that I have been reading lately ... they just blow my mind with what they have proven ... in vitro. So this begs the question. Where is the PR machine? As others on this forum have demonstrated with articles about other drugs and pharma companies, one does not need an approved drug to strike home company value. But we have one now. Some variants of this drug are simply more selective as to its effects. Scenesse is approved; these variants I speak of are subsets. It should not be too hard to push these variants over the finish line as a cure and treatment for many other diseases that affect a much wider class of people. It could simply be that approval was so in jeopardy due to the regulators that all had to remain quiet. This is my hope and this is why I am still hanging on, but I have not bought any further shares. I don't know what you call that, pessimistic optimism?
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endymion96
Posted on: Feb 8 2015, 05:45 AM


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LRS, I appreciate your summary of milestones to be accomplished. I am still hanging in there, but at the same time, PW's statement about not pursuing the anti-inflammatory, anti-microbial, and anti-oxidant qualities of this drug that have been scientifically proven in the research reporting of many individuals and labs spanning many countries over a period of the last decade ... in favor of its photo-protective properties, which is merely a side effect of what the drug is actually doing, seems misdirected to me. For instance, research has shown that the appearance of Melanocortin receptors throughout the body and in the skin and brain particularly demonstrates that they play a VERY important role in the defense of the body and are a vital part of the immune system. To not comment on this fact or to brush it off as what was the phrase, "just not practicle or possible" or not "ethical" at this time seems misguided. Cosmetically, yes, but as for the other possibilities, WTF? PW, please correct me if I am wrong.

While I will be holding on to my CUV stock, at the same time, I will be looking for other companies who wish to exploit the tremendous potential health benefits of this drug. My original question (asked last September) about the patent rights of Clinuvel regarding Scenesse where it concerns its anti-inflammatory, anti-microbial, and anti-oxidant effects have never been answered. And in fact, the Chairman's Address presented some doubt in my mind if the company will even pursue this direction in any meaningful way and in any meaningful timeframe, as I have heard no statements to contradict my fears other than ... maybe down the road we might look into it?

If some people on this forum want happy talk they are entitled to their opinion. If others want a counter-balance to happy talk presented with logical reasoning by somebody who has been tracking the progress of this drug for 14 years ... you will hear it from me. As a long term investor, I appreciate the work that has been done thus far. It truly is a tremendous accomplishment. My point however is, when research has proven that we stand at the precipice of science with this drug and the company shrugs off its potential with two sentences in the Chairman's Address, some of us investors better take notice and start asking hard questions ... and keep asking them until we get answers from management.

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endymion96
Posted on: Feb 7 2015, 10:19 AM


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I feel like Linus ... waiting for the Great Pumpkin to appear out of the sky! Sad to say, but I have heard what you are saying many times before. At this point, actions speak louder than words. So I will sit and wait in the pumpkin patch until that day comes.
The reason I believe PW is not on target is because of a post I made about a month ago which showed hard scientific fact that anti-biotics paired with a long-acting MC1R analog will do amazing things. If I were PW, I would start game planning this new capability as fast as I could. If he wants to light a fire under the share price and assist all of the longs as he said he would, that syngistic effect is the golden ticket and the way up on a rocketship. Another reason to want to boost SP is no fear of a takeover or a buy-out. Simply the mere mention that Scenesse along with an anti-biotic can cure the most virulent strain of MRSA out there (given the safety profile established already) would be a home run ... even at Phase II.
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endymion96
Posted on: Jan 12 2015, 05:28 PM


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Yep, this is what I have been saying all along.
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endymion96
Posted on: Jan 7 2015, 09:46 AM


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We already know the answers. Its not one incident of sunburn that can cause skin cancer, nor is it a long buildup of UV exposure over one's lifetime that causes it either. Skin cancer will occur when certain parts of your DNA have been mutated such that some genetic piece no longer function(s) and/or causes certain cellular imbalances. Repeated UV exposure for sure increases the chances that certain harmful mutations may occur, but skin cancer is not gauranteed by some arbitrary long period of time ... it completely depends on which mutations occur (because the body failed in preventing or blocking them although it usually does) ... and its not just one mutation, its several specific ones. You'd have to be unlucky enough to be afflicted with just these mutations.

So the development of skin cancer is a series of specific mutations. Its like unlocking the combination to a multi-combo lock. How many digits in the combination, I am not completely sure, but there are several. Wth each UV exposure you take the chance that one of the digits in the combination is found. Eventually, if you are unlucky, your repeated UV exposure will finally crack the lock and open the cancer vault. Scenesse skips the inherent riskiness of exposure and in fact strengthens the lock by boosting the immune system repair pathways which insure the lock's combination stays secure. In other words, it prevents the digits of the combination from being found. The tan is a side-effect.
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endymion96
Posted on: Jan 4 2015, 04:36 AM


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You don't seem to be listening. Do you think my "overdose" was the normal? No. I was experimenting just as Epitan was experimenting with dose ... but on my own. And from my experiences with dosing levels ... and from Clinuvel's reported info on their slow-release implant, I am telling all who read this, it is NOT slow enough. From the info Clinuvel reported of VERY COMMON and COMMON side-effects ... and from my own experiences in very much lessening those stated side-effects, I am telling all who read this, it can be done. Why after all that did I invest? Because the drug works. Period. What do I think of PW and his golden compensation package, I was iffy before, but after discovering the posted side-effects, not much at all. Wondering who is really minding the store now? I invested because the drug works and this is the company with the rights and patents. Simple as that. It works so well, if you have dry skin in winter ... so dry that you scratch yourself raw, then take 1mg every other day 4 times for a total of 4mg ... no more dry, itchy skin for two months ... Enough to get you through winter's harshest. And the first subcutaneous injection made the itch go away, the rest were for a lasting effect. I suspect those suffering with EPP are willing to take on the side-effects because they are temporary unlike the disease they are afflicted with. I would as well. The thing is, once the drug is in your system and active, re-taking it a couple months later, the side-effects aren't as great. But to those who had never been exposed, the first time will be a doosey unless Clinuvel heeds my advice and make the so-called slow-release implant alot slower. All that said, it is a life changing drug. Do see now why it was not such a slam dunk weall thought it was with the regulators? But the thing is, it could have been. And with a small change it could be rectified.

P.S. in my opinion, a cure for dry skin is the very, very, very, very least of good things this drug will treat. I have unlimited optimism for this drug. My negative comments as to its administrative protocol not withstanding.
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endymion96
Posted on: Jan 1 2015, 06:25 AM


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Excuse me but were you one of the early pioneers running experiments with the real drug? Have you experienced what it feels like to overdose yourself on this? You feel absolutely sick to your stomach and will vomit within 30 minutes. You will not be able to sleep. You will have a headache for many hours. You will feel the need to continuously stretch your body. You may have facial flushing and feel hot. You will not want to eat for feeling nauseous. Your sinuses will act up and it will appear as if you have a cold. Don't brush off my complaints like that. You know nothing about it. I have experienced it first hand. If its bad enough, you will feel like you are going into shock and need to lay down ... but you can take an antihistamine to countact the effects. Once you have experienced an overdose, you never want to do that again. Its freaking ridiculous that these effects are counted as very common and common among the patients. All that is required is to lower the level of steady stream dosing to minimize them and yet Clinuvel at this point is going to market with the current implant. Yeah, its tolerable, but why should anyone tolerate it when it can be corrected? After all this time. Sorry to be the bearer of unpleasant news, but this is a misstep regardless of whether you want to believe it or not.
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endymion96
Posted on: Dec 31 2014, 02:12 PM


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In addition, you have to condition the body to deal with Afamelanotide with very small dosing levels at first then build up to a bigger level. The slow-release has to be tapered if that is even possible. Facial flushing and vomiting? Oh my goodness, I did not expect this kind of misstep at this point. I certainly hope somebody from Clinuvel is reading this and the lightbulb turns on.
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endymion96
Posted on: Dec 31 2014, 01:59 PM


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I can't believe after all their trials ... that they do not know the reason why there are so many common side-effects ... it is because they are releasing too large of a dose in too short of a time! It is incredible to me. If they could develop a better slow-release formula, these side-effects would be minimized completely and may not even be felt other than the back needing a good stretch and a lessening of appetitie. Headaches and nausea would go away. Do they not know this at this point? What the hell? You can't release 90% of 16mg in 48 hours. That is ridiculous. I'm very shocked. No wonder the drug was approved under extraordinary circumstances. Please Clinuvel, do yourself and your patients a favor and refactor your implant.
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endymion96
Posted on: Dec 11 2014, 09:33 AM


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Sorry, wrong choice of words. Completely cosmetic is not what I meant, perhaps cosmetic in appearance is better. But of course, the negative psychological effect is not something to simply brush aside and it is the entire reason that Clinuvel chose this path. In my opinion, this disease was chosen in the short term because it is bonified, but it also shows the power of the drug's pigmentary response. However, my point is that people die from other diseases where research has shown that a-MSH analogs will improve, treat, and maybe even prevent such as Alzheimer's Disease and the damaging effects from a stroke.
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endymion96
Posted on: Dec 11 2014, 08:38 AM


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I also found that phrase a curious turn of words. Thinking on it further, it makes no sense at all. A Vitiligo treatment would be completely cosmetic and I have no doubt that Scenesse works not only as a photo-protective drug but also as an anti-inflammatory with EPP. So what is he really saying? My guess is it has something to do with the regulatory bodies and the pressure they are exerting on the company not to let the cat out of the bag just yet. Although I could not blame management for going along, I do wonder when the dam will burst? I think we all need to hang in there for at least two more years to see if the regulatory bodies relent. The science is becoming hard to ignore. Along those lines though, how could they prevent a synergistic use with antibiotics? If PW is not aware of this research, somebody needs to let me know. Because if the real reason of slow pace is regulatory in nature, this type of new research could make acceptance more palatable.
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endymion96
Posted on: Dec 10 2014, 04:44 PM


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New research shows that a-MSH combined with conventional antibiotics makes for a potent weapon against bacterial infections such as MRSA. I'm sure you've all heard that humanity may be reaching the end of the line with antibiotics against the mounting resistance of bacteria. Well, this articles explains that this point of view may no longer be true. This is a very exciting prospect for Clinuvel. It is my belief that taking the company in this direction would lead to more profitable results. Or at least the announcement along such lines. This is the kind of thing that excites investors. Hello PW, are you reading this? Make it happen before somebody else does.

http://www.plosone.org/article/info%3Adoi%...al.pone.0073815
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endymion96
Posted on: Dec 3 2014, 03:27 PM


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I can add a little to this discussion ... a long-lasting form of alpha-MSH such as the drug we have all invested in has many potential benefits. Tumor growth is driven by the cell's ability to outwit the normal processes which cause it to die. Normally, a cell has a limited lifespan and can only divide so many times before its ability to divide further is degraded to the point where it enters into the death phase and is purged from the body. Cancer is the ultimate form of mutation, but it takes many DNA mutations to get to this point. Along the way, these mutations may bring about a form whereby the processes that control cell death are shut off and cancerous or pre-cancerous cells become immortal (able to divide indefinitely). But in order to get to this state, the DNA mutations must occur. So the question is, how do these mutations occur? There are several ways but UV damage, heredity, carcinogens, and free radicals all play a part. The great news is that our little wonder drug turns on many valuable pathways that defeat such situations from getting out of hand and may even play a part in stalling or reversing the aging process. It does this through its anti-inflammatory effects, and DNA repair pathway effects, its anti-oxidant effects, and its increased production of eumelanin which provides UV protection. This is why I am willing to wait it out. Because of its long-lasting effects on the MC1-R, Scenesse provides much more than simple photo-protection. I am still researching when I can, but I am looking to see if its effects on the body actually work in a way to halt tumor growth. I have reason to suspect that it can because if it does, it would solve the progression of many types of cancers due to the fact that once a cell can no longer divide indefinitely, it will eventually die out and thus, if it is cancerous, the cancer would in turn eventually die as well.
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endymion96
Posted on: Dec 1 2014, 05:31 AM


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I am going to hang on for another year or so and see what FDA approval brings? My hope is that Scenesse gets approved in the USA and that regulatory restrictions aren't as tight as they are in Europe. Then I am going to hope for off label prescriptions for other indications and word of mouth to spread in a big pool of potential investors.
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endymion96
Posted on: Nov 29 2014, 04:58 PM


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I don't think there is anybody out there that does not appreciate what has been done here to date. But let me say this, Instead of investing 10 years ago, I could have bought all my shares in July and done just as well. All I want to know from the management team is the forecasts for future milestones so that I can gauge my profitability timeline. If that happens to be 5 years from now, I will take my money out and come back later. It is not a bad thing to want to know these things. Time is money.
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endymion96
Posted on: Nov 25 2014, 03:10 PM


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I am also reading that an alpha-MSH derivative with a long half-life (Nle, D-Phe alpha-MSH or NDP-MSH) had the beneficial effects of reducing neuronal death (death of brain cells) and hippocampal damage and thus, improved functional recovery from stroke if given treatment between 3 and 9 hours after insult of stroke. In the US, the stroke is the 4th leading cause of death affecting something like 800,000 people a year. Imagine the possibilities?
Here is the article. It is a recent 2013 general survey of alpha-MSH and its anti-inflammatory effects. Clinuvel and other companies are mentioned toward the end.

http://www.hindawi.com/journals/iji/2013/985815/
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endymion96
Posted on: Nov 25 2014, 01:38 PM


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Treatment for arthritis anyone?
"Our results indicate a-MSH and related peptides as a potential new class of drugs for the treatment of inflammatory arthritis."

http://arthritis-research.com/content/11/5/R151


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endymion96
Posted on: Nov 25 2014, 01:19 PM


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I thought you had the right intuition, but wrong timing. I would have waited until after AGM. I am expcting a surpize to come out of that meeting. But you got back in, I think in the nick of time.
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endymion96
Posted on: Nov 18 2014, 01:16 PM


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Exactly, which is why I would like to hear a response straight from the horses mouth. We, as shareholders, need to judge just how great of an investment owning a share in this company is. We need to know when to expect a good return on our investment. If the answer to my questions is that they don't have it all locked up, then my next line of questioning will center on how soon will we see shareholder value increased and what are they going to do to make that happen. And finally, this can all be traced back to Resolution #9, Dr. Wolgen's proposed compensation and hitting the proposed goals set forth. I, like a few others, think those goals are not set properly and I also think the compensation is too much (at this time). We all need to be treated fairly. And compensation should be rewarded when fairly earned. Getting a drug approved by EMA is a major milestone indeed, but so is 10 years of investment without a return. Both balance each other in terms of patience and committment.

From what I read in the Annual Report, Dr. Wolgen and company have laid out solid plans for the future and I applaud them for this direction. What I need to know is, will my investment be a good one or a great one. Time is money. I can almost guarantee that if, Dr. Wolgen wants that compensation package, then he will pull out a surprize for us before the AGM occurs. Shareholder voting ends Wed, Nov. 26 I believe. So we may have news before then.
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endymion96
Posted on: Nov 17 2014, 08:55 AM


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Does anybody know the answer to the following questions and if not, can somebody ask it at the AGM? The question is, "Does Clinuvel hold patent protection over future possible indications of Scenesse such as those associated with its effects as an anti-oxident and/or as an anti-inflammatory?" In addition, "How will Clinuvel position itself to 'stay steps ahead' of the competition (as Dr. Wolgen stated in the 2014 Annual Report) and in what regard? Branding/Marketing, IP, Research, etc?".
Along those lines ..."Is patent protection limited to drug delivery methods targeting MC1-R at this point? Or is it strictly limited to only the exact formulation of Scenesse targeting at MC1-R? Or does it encompass all analogs of alpha-MSH? Please elaborate. Could a competitor develop a different analogue and target MC1-R? Just how is Clinuvel insulated from competitors at this moment and how long will it enjoy such beneficial positioning?"

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endymion96
Posted on: Nov 6 2014, 11:07 AM


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I think the big prize will be had once they finally prove that this drug can be used as a preventative for skin cancer. That is a clear medical need and appropriate use. It is also what the discoverers of the drug had envisioned when they first set out to do the research. The buzz over a preventative/treatment/cure for skin cancer is what the investment world will go bonkers over! Imagine that?
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endymion96
Posted on: Nov 5 2014, 02:49 PM


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Who would vote for this takeover bid? I wouldn't.
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endymion96
Posted on: Nov 4 2014, 02:40 PM


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But I have been saying all along that strategy won't work with this group because we keep buying on the troughs and not selling on the crests ... most of us anyway.
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endymion96
Posted on: Nov 4 2014, 02:36 PM


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If the manipulators are manipulating, they are doing it for a reason. Could there be a large shark looking to shake out the small players with crazy SP moves? I could see somebody doing the old rope a dope. Swing up then down, then up and down ... and lull all of to thinking it will be safe to sell at the high side and buy at the low side. And as we take ever bigger risks by putting more of our shares out on the crests and troughs, they will at some point in the future ride a big wave up and this time buy out the sellers and push the SP way up. Then some of you will be caught with your pants down? I don't know ... Just trying to put out a plausible scenario on the manipulation. Otherwise, why start swinging it up and down? Why not push it up and keep it there?
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endymion96
Posted on: Nov 4 2014, 09:29 AM


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Yes, I saw that too .. as Seeva pointed out. Either the ADR market did not buy what the AUS market was selling yesterday and is now establishing a more normal SP rise or the ADR market is very, very thin and should just be ignored? Or a combination of both if that makes sense? It will be exciting to see what the AUS market does today. My belief (as I stated yesterday) is that the manipulators are testing the sell point. If we don't see a big sell side today, they may just push the SP even higher until they see action. At that point, they will know the current high/low sides. If my theory is correct, must of us are long and they will need to push the SP higher than they think.

If any of you on here are selling, it would be interesting to know if you are just taking some profits because you don't think the SP can get higher for awhile or if you are reducing your holdings for good because you want out? Personally, I never used to play the roller-coaster games because I always thought that this stock would take off like a rocket and not come back down to these levels ever again. Over the years, I've seen things play out differently. That is why I think its going to be really hard to push the SP up until we get above of the $10 range.

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endymion96
Posted on: Nov 3 2014, 04:51 PM


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Oxidative stress comes about due to the production of pheomelanin. I find it interesting that the sufferers of Vitligo are often in the higher Fitzpatrick groups ... their melanocytes normally produce eumelanin except in areas where they don't ... hence the patches of lost pigmentation. We know that Scenesse seems to bring back the pigmentation and fill in these areas. So it is acting as a powerful anti-oxident and also is switching back on the repair pathways.
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endymion96
Posted on: Nov 3 2014, 03:51 PM


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If anybody wants to get an idea of just which pathways, targets, processes, genes, enzymes, and in general, biology is involved ... have a read of this article by Dr. Fisher and Dr. Hsiao. It is very new, August 2014. I was reading it trying to find more info on how an alpha-MSH analog could effectively prevent or reverse melanoma. The key here is MITF regulation. It is the master regulator of the melanocyte cell.

http://www.sciencedirect.com/science/artic...002707?via=ihub
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endymion96
Posted on: Nov 3 2014, 02:33 PM


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Anybody think this is a test to see when the longs might start selling a bit of their holdings? Or am I being a conspiracy theorist?
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endymion96
Posted on: Nov 3 2014, 10:00 AM


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Klomp, thank you for posting the info. I don't think Scheme #1 will occur unless the bid would be substantially higher, say in the $20-30 range (and even then the BOD would only give you the chance to vote, I couldn't say what the outcome would be). By virtue of an approved drug, with more indications and other formulations to undoubtedly come down the pike, the company now has a sure revenue stream coming in. The BOD, I think, would reject any such low-ball offers below $18 because of that. Especially since they have once again reiterated (for the third time) that Clinuvel is transforming into a major commercial operation. Wolgen of course wants to be at the helm of an historic company such as this with a drug that will change the world.

Scheme #2 may be a slight possibility only in the sense that some entity may gain a majority of the shares, but I doubt it would come close to a takeover because most of us longs (and quite frankly that probably includes 80% of the shareholders as my guess) aren't going to reduce our holdings by any substantial amount. We all realize the potential ... and have realized the potential from the very beginning. I think this is in fact how we all found out about this company ... we researched the topic, found the drug, which led us to Epitan/Clinuvel, and then we invested heavily. It is my belief that the makeup of the shareholder base with its long standing position in holding shares will not let go until we receive just reward for our long wait. When that day comes, all who are invested now will have ample opportunity to sell their shares to a large pool of brand new investors who will be buying in at 10-20x today's price. That is my take anyway.
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endymion96
Posted on: Oct 31 2014, 06:10 PM


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One last thing. I wanted to point this out a few days ago when it crossed my mind, but forgot about it. After reading the Florian post, the idea surfaced back into memory. Wolgen and others in Clinuvel stated that "safety" is THE number one priority going forward. To me, this is a signal that he is setting up the prospects for all future indications to adhere to that one principal for one gigantic reason. Years from now, when the safety profile is set in stone ... this drug will eventually go mainstream. Perhaps for mostly humanistic reasons, deservedly so. And why shouldn't it? And why shouldn't we reap the rewards? People keep talking about a potential buyout by Big Pharma? Nonsense. Wolgen alrady telegraphed he is not going to let that happen. And as I said previously, the regulators are not yet prepared to let the dogs loose on this drug so it will not even be a possibility for years. By that time, things will be well in hand.
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endymion96
Posted on: Oct 31 2014, 05:29 PM


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Posts: 361

Since Florian seems to read our posts, let me say, I agree whole-heartedly on the human dimension. I venture to say almost everyone on here invested in this company because of it. And of course because we saw the huge potential for this drug to treat millions of people, we as investors also saw the huge potential to gain monetarily from the science. My personal story ... I am one of those guys who does not tan. Never have. I remember getting savage burns at the beach, while my friends soaked in the sun. This sad fact led me to do research on the internet to try and discover how I could protect myself and maybe even improve my appearance. Of course I saw all the fake products and even tried them, but there was this one bit of research that actually held promise of a cure for my condition. I eventually became so obsessed, I started reading 1000 page books on "The Cell". I become interested in biochemistry and Immunology and I even thought about going back to school to earn a degree in the field.

But, as the summers went by and progress was slow, I took to researching the patents to see if I could get my hands on this drug. Because of my condition, I was willing to take the risk. But I did so with reputable peptide manufacturing companies here in the US. That first summer 8 years ago ... as I sat on the beach in mid-day sun, after having experimented with dosages and gone through an experimental course, I sat there in disbelief. No burn ... maybe a little color after a full afternoon, but knowing what I'd experienced all my life, by comparison, there was no burn. At that point, this drug was my miracle cure. Invest in Epitan, oh yeah you better believe it!
So, my point is, most of us here probably bought this stock years ago, when the risk was very high, and the probability was that it would never succeed, on faith that a cure might eventually be available. Most of us bought this stock because we were sufferers of various skin disorders, but we had hope that one day there would be a miracle cure. So now, after 10 years of waiting ... I want my cake soon and I will someday eat it too. Anybody else with me?
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endymion96
Posted on: Oct 31 2014, 03:31 PM


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Posts: 361

I think we all kinda know when this rocket is going to leave the launch pad. It will happen when we start seeing much more revenue come in. Money talks, bullsheet walks. Next on the agenda will be FDA approval, US market investors will then think, hmmm this company has just opened up the market to a bunch more people. Then of course, the Vitiligo trials will attract attention. At this very moment, the thing that will push momentum forward is insider buzz. I still have yet to see the folks who provide the stock tips to the masses tip them off to our de-risked beauty. That should happenly shortly. That is currently what I am tracking ...
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endymion96
Posted on: Oct 31 2014, 03:14 PM


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In The Groove! Now there's a blast from the past. What about Melanotan? I wonder if he's still around too?
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endymion96
Posted on: Oct 30 2014, 09:30 AM


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Don't forget Eczema, Rosacea, AK ... Wolgen hinted at SAD too ... not to mention there have been no trials to see whether this would reverse or prevent Melanoma or SCC. Clinuvel should at least run the mice studies and see what those results are. Imagine if they were positive ... that is the kind of buzz that would shoot the SP up to where it should be. For that, I would let Wolgen have his performance bonus.
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endymion96
Posted on: Oct 29 2014, 04:03 PM


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I am just tired I guess. I have been holding my shares for almost 10 years. Shouldn't that be worth something by now? Figuring the time-value of money? I guess I will go back to hibernation. On the bright side, my investments in other areas such as graphene, 3D printing, uranium, and SSD technology are doing well.
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endymion96
Posted on: Oct 29 2014, 03:13 PM


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This is not shareholders at all. Did you see PortoMan's chart? Who sells 17, 1, 22, 7, etc ... shares every 5 minutes? It is a conspiracy. They way you frame it, it makes one think people are done with the stock. That simply is not the case. But that is exactly what the manipulators want people people to think. So why reiterate their bull?
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endymion96
Posted on: Oct 29 2014, 11:26 AM


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Posts: 361

The volume is low and yet these manipulators who are selling and driving the price down further ... they are killing the goose for the long run. Imagine you are a new investor looking at this company's stock price fluctuations! Who would come in and join a party like this? Anybody out there with a lot more money than me, you might wanna consider playing the game in the opposite direction to counteract this nonsense. Why don't you try buying anywhere from 1-70 units every five minutes and push the price up? Freaking ridiculous that the price would drop so low just after the company has de-risked. Sure you make a few bucks for now ... but if you let the SP build, you might attract more people to the company and sell later at a much higher price! Well my friends, after the manipulators have had their fun, where will we be? I don't see this mess straightening out until the company starts raking in serious revenues.
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endymion96
Posted on: Oct 29 2014, 03:00 AM


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It is probably a group of people in collusion ... would be akin to a group of card-counters ripping off the casino. Porto's got it right though ... fantastically small parcels being bought at 5 minute intervals. This group aren't very refined.
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endymion96
Posted on: Oct 29 2014, 01:27 AM


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Posts: 361

Manipulation is easy and could easily go the other way, but for now, the downers are controlling the game. Any uppers in the house? How low will they drop this stock? Last time it was down to $2. Just remember people ... until we get a wider shareholder base, this kind of thing will continue. Do not despair! I wonder if I should go back into hibernation so as to forget about these quick traders for awhile? They are really annoying.


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endymion96
Posted on: Oct 28 2014, 02:41 PM


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I can't tell you how excited I was to read the report. There are so many hints in that thing as to where Wolgen thinks he can lead us, its just incredible. The future of this company is going to be huge. If anybody hasn't read it yet, read it a few times and you'll see Wolgen is pretty clear in his wording that he can take this company to the top without a doubt. When I read about Seasonal Affective Disorder in the report ... that pinged my radar screen. Call me crazy but that may become a future possibility for this drug. Probably way in the future, but he is definitely hinting at a wide market potential. If the FDA and EMA need diseases, we'll give them diseases to treat. I think that is what he is hinting at. But again, this must be done slow and steady ... so we have a ways to go.
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endymion96
Posted on: Oct 28 2014, 02:31 PM


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Normally, your analysis would be spot on, but I know many investors have been in this stock for so long they have grown grey hairs by now and just want to take what will be a nice profit and get out while they can still enjoy it. That is why I see a tough slog up around the $10-15 dollar range. When we burst through that, the sky is the limit ... but as said, not for several years. If I am wrong, I will be very happy to be wrong. But seriously now, how could anybody be selling this stock when the company and the management team and the future possibility for treating a wide range of skin diseases is so clearly attainable? This is why I say the only sellers now are the day traders who have no knowledge of this company, stock, or drug. It makes me ill, but in the end, we'll all meet on the beach and have the last laugh. Those day traders are just making it that much longer to get there. But really, what roadblocks does anybody see at this point?
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endymion96
Posted on: Oct 28 2014, 10:41 AM


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Posts: 361

My honest opinion on this stock right now is that the people who are buying is basically us ... who've known about and been invested in this company from the beginning and perhaps those who came in several years ago. Those selling are professionals who were tipped off about this stock and are in it for a quick buck. Until volume gets into the millions, the SP is up for manipulation down/up. The problem with this short-sighted thinking is that eventually those of us buying will run out of money and/or be beaten into submission such that we will no longer be buyers. And then what happens? Those dummies who are selling have lost out on selling at a much higher price because they thought they could milk this cow all day long. What they don't know is how many trials and tribulations we longs have suffered over the years. So if they want to play this game, they are basically killing the goose that lays the golden eggs for quite some time. Price spikes that we dream of seeing are still far off because of this. If you are waiting for $10-$15 range, that will not happen until after FDA approval and Vitiligo trials are over and Vitiligo indication is approved. At that point, we will sit near $10 because some longs will just want to get out and take a modest return on all their years of investment. If you want to wait for the big bucks, that is still 5 years off in my opinion. Medium bucks is 1.5-2 years away.
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endymion96
Posted on: Oct 28 2014, 08:44 AM


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And volume was 10x normal ... so that is pretty good, eh?
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endymion96
Posted on: Oct 28 2014, 02:42 AM


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"Can we seriously expect Clinuvel to manage an indication like Vitiligo without partnership? Assuming approval is 2-3yrs away, we would have to build a substantial global network at large cost. Would the regulators be similarly "scared off" by a partnership with Big Pharma?"

I'm not sure, but this is what I believe Clinuvel stated in their latest announcement ... and that is why I brought it to everyone's attention. What is your take?
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endymion96
Posted on: Oct 27 2014, 03:57 PM


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Posts: 361

If what I read and surmised is correct, Clinuvel cannot consider a buyout from a large pharma because they would then scare off the regulators. They would scare them off because EMA does not trust that proper care would be taken to limit off-label use in the much larger distribution channels of these giant pharmas. So, Clinuvel is now stating that they are transforming from an R&D company into a commercial operation. This is necessary to prove to the regulators that if/when future indications and drugs come before their panels, upon approval, that the company can be trusted due to its intimate relationships within the field of prescribing medical professionals. At the same time, Clinuvel will be expanding the market with such indications and drugs under protection of IP and market exclusivity as a growing pharma in its own right. The future looks very bright!
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endymion96
Posted on: Oct 25 2014, 12:57 PM


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One thing bothers me about the EMA press release and that is that they stated that .... there was a lack of robust efficacy data because of the difficulties of placebo-controlled trails. Patients in these studies were not willing to expose themselves to sunlight for fear of developing painful symptoms. They went on to say that approval was given under exceptional circumstances with the condition that Clinuvel puts in place a robust risk management plan that ensures close surveillance of the safety and efficacy of the medicene. As part of this plan, the company will establish a registry of patients to collect safety and efficacy data.

My take on this is that EMA really wants a tight leash on Scenesse right now because they are afraid of the off-label use. I simply cannot believe there is a lack of robust efficacy data with this drug. That is a crock. If that were true, they should have denied it. But they didn't. This tells me the data was a slam dunk; however, in order to grant approval, they needed a plausible reason to put a condition on the drug that they felt would provide a reasonable hurdle (for now) to prevent runaway use. And that is this condition to establish the registry for "surveilance" and the additional paperwork that prescribers must adhere to in order to follow up on all patients given the drug. That said, I'll take the unanimous decision and couched language as a sign that what we have here is a blockbuster drug.

I'm sure they would have liked to see more data on this drug's effects with other skin disorders though ... as they know it has positive effects as an anti-oxident and anti-inflammatory and its activation of DNA repair pathways has huge potential for an advancement in medicene. But seeing as how these trails are years off, they decided to go ahead with approval ... as well they should have.
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endymion96
Posted on: Oct 25 2014, 04:39 AM


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Posts: 361

That is correct. The larger, more liquid market on the ASX will reset the tone on Monday. I expect that the ADR "market close" price on CLVLY will NOT set the real price and that CUV will push higher on the ASX (factoring in the exchange rate) in relative terms because of the bigger pool.
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endymion96
Posted on: Oct 25 2014, 03:21 AM


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Posts: 361

Hi all, not to throw water on the parade but my prediction (a few days ago) that this stock will now trade in the $4-5 range is probably accurate. Although the ADR volume is huge today, I still think this a thinly-traded stock that is open to manipulation. I haven't sold any shares in 10 years and I'm not about to with EMA approval accomplished. Now its on to FDA approval ... which will be another huge upswing. But with what I have seen, don't expect to cash in just yet. In the coming months there will be downward pressure from those with big piles of shares wanting to cash in some portion of their treasure trove ... especially when the SP hits the $10-15 dollar range which will not occur for awhile (my estimate). So, those waiting to see the $40-50 range like me have a ways to go. But I'll wait ...




On the plus side of the ledger, we have EMA approval and the potential for this drug to prevent/treat/cure many other diseases ... also now that Clinuvel has made its first big splash in the biotech world, there will be the analysts reports which will attract the attention of the big boys. So that is good for moving the ball up. As with the energy sector, this game is not easy but I hope we all make it to the finish.


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endymion96
Posted on: Oct 24 2014, 01:07 PM


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Posts: 361

One thing that will be interesting to see with this reversal of leadership from ASX to ADR will be ... just how much interest there is in this company coming from the US market. We should be able to judge how much the average US biotech investor knows about this stock by looking at the volume of the days trading in CLVLY shortly. If anybody is going to get in on the ground floor, now would be the time. I would like to see the volume smash its current average, but I am not so sure the company is widely known in US biotech circles just yet. We will see. The anticipation is killing me, but the payoff is hopefully just around the corner. Still looking forward to the day when we all meet on the beach in Oz for a few pints! Cheers!!
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endymion96
Posted on: Oct 24 2014, 06:51 AM


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Posts: 361

Let's do this!!! @Clinuvel
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endymion96
Posted on: Oct 21 2014, 04:18 PM


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One would think after 10 years or so that we would have shaken out all the riff-raff by now? What a bunch of scared little babies running for the hills ... with approval just ahead. All this time you wait to go running off now? Makes me laugh at the insanity of this herd mentality.
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endymion96
Posted on: Oct 20 2014, 03:58 PM


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Posts: 361

Ok, enough of this crap! You people who are selling you shares in Clinuvel could be making the biggest mistake of your lives. Why do I say this? Because the drugs that have been formulated by Clinuvel, which act significantly on the MC1-R receptor, will become a very big part in the prevention of melanoma and other skin cancers. I was watching a documentary called "Cracking the Genetic Code". While watching, I learned that a mutation of the BRAF gene is found in 70% of melanoma cases. But it is more complicated than that. I knew that the signaling pathways in melanocytes played a key role in this cancer and thus I knew Clinuvel's synthetic analog of a-MSH might somehow play a part as a preventative or cure because I have known for years that it not only protects the skin from UV damage, but it also has amazing anti-inflamatory properties and is known to remove free radicals. So with this, I did a little digging to find out the latest research on the causes of melanoma.
What I found was that recent research, conducted in 2012, on mouse models suggests that melanoma is caused in people with genetic mutations in the BRAF gene and who also produce mostly pheomelanin. In other words, fair-skinned people with the mutation of the MC1-R. The study suggests that UV-exposure is not necessary to cause melanoma, but it will make the situation worse. So basically, the signalling pathways that cause an increase or abundance of pheomelanin can produce melanoma in people who also have the BRAF gene mutation in almost 70% of the cases. Now, what drug do we know of ... what drug can decrease pheomelanin and switch the signalling pathways to instead produce the beneficial eumelanin? What drug can overcome the MC1-R mutation to do this and perhaps prevent melanoma? I wonder?
http://arstechnica.com/science/2012/11/for...e-in-the-genes/
http://www.massgeneral.org/cancer/advances...13melanoma.aspx
http://dermatologistsblog.com/skin-cancer/...a-in-red-heads/
This research is from 2012. The scientists are still only at the mouse model stage and yet they recognize something that we already know. I know this from personal experience. The protective properties of eumelanin and the DNA repair processes that go along with it are indeed a preventative and perhaps a cure for skin cancer.

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endymion96
Posted on: Oct 19 2014, 06:33 AM


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Posts: 361

I would like to add a ray of sunshine to what has become an otherwise dreary forecast of late. I am unshaken in my belief that this drug will be approved. Why? Because this is a first in class treatment/cure/preventative for what is a brand new frontier in medicine (i.e. the Melanocortins).

"The melanocortin group of hormones acts as part of what is termed the melanocortin system, which affects many processes in the body, including the urge to eat, pigment formation, inflammation, energy levels and the sex drive."

I think this is partly the reason why it has taken so long for EMA to come to a decision. They would be opening up new ground upon approval. Afemelanotide is the corner stone of this house. Its a landmark decision. I am excited about the future possibilities ...


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endymion96
Posted on: Oct 17 2014, 04:39 AM


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Posts: 361

An educated guess here ... I think I eluded to this a couple posts ago. I do not think the SP will vary that much even if we receive approval because I don't think the wider investment community knows about this drug yet. What I expect to see after approval is that the SP stabilizes and rises slightly (maybe back up to $4-5). But unfortunately, I think it may take another year before word gets out about this needle-in-the-haystack that was finally found after 12+ long years. I will elucidate my marketing strategy for this drug after we hear about approval. Until then, let's cross our fingers and hope this fairytale turns out they way it should.


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endymion96
Posted on: Oct 10 2014, 01:17 PM


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Posts: 361

I don't understand how this company's stock is being bid down just days away from a final opinion. It does not make any rational sense. How many companies in the biotech space have a drug that even gets close to this point ... as they are more likely to fail before arriving at the final destination? I believe this is a shrewd trader attempting to manipulate our secret little market. I am not buying into it. You would have to be stupid to sell any shares below current value at this point ... assuming you have no insider information of what the decision will be. Nobody needs the money that badly, especially considering the small parcels being sold ... because the upside upon approval is so much more appealing. The reward to hold course at this point is the "rational" behavior I would expect. To do otherwise is an obvious attempt at playing with the stock price.
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endymion96
Posted on: Oct 10 2014, 03:53 AM


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Posts: 361

From the patent info ...

"In this study, we demonstrate for the first time that topical application of full-length .alpha.-MSH formulated with a particular vehicle and enhancer in water is effective in treating skin inflammation when .alpha.-MSH is first applied only after inflammatory presentation. We utilize a mouse model that is widely accepted to closely mimic the inflammatory response of allergic contact dermatitis in humans to demonstrate the anti-inflammatory effects of topical .alpha.-MSH treatment in a clinically-relevant timeline.

Allergic contact dermatitis (ACD) is one of the most common cutaneous inflammatory disorders and can be caused by hundreds of different substances that a host recognizes as an allergen (27). These are encountered both in occupational or private settings. ACD results in spongiosis in the epidermis, dilation of the papillary vessels, perivascular lymphocytic infiltrate, and edema in the upper dermis (28). These histological observations were made in the ACD-induced tissue analyzed in this study, and these responses were noticeably alleviated following treatment with corticosteroids and .alpha.-MSH. ACD shares the histologic pattern of spongiotic dermatitis with other forms of contact dermatitis and atopic dermatitis and exhibits similar therapeutic responses to anti-inflammatory agents. The most common therapy currently used is topical application of corticosteroids. The anti-inflammatory and immunosuppressive effects of corticosteroids include changing migration patterns of leukocytes as well as inhibiting lymphokine synthesis and monocyte function (29). There are also pronounced harmful metabolic and toxic side effects, which may include skin atrophy, striae, perioral dermatitis, acne rosacea, and the potential for systemic absorption that could lead to adrenal atrophy, Cushing's syndrome, growth inhibition, hypertension, vascultits, and a host of other damaging effects on various systems (11, 29). Adverse side effects are more likely to arise from long-term application of corticosteroids.

In the last decade calcinurin inhibitors have become clinically available for the treatment of different forms of dermatitis, with tacrolimus and pimecrolimus gaining US FDA approval for the treatment of atopic dermatitis in 2000 and 2001, respectively. Tacrolimus and pimecrolimus are the most widely used calcinurin inhibitors, and each exhibits fewer adverse side effects than most corticosteroids (30, 31). However, burning, pruritis, and allergy in certain circumstances may limit their use (30-32). In 2005, the FDA issued a black box warning about the potential carcinogenic properties of tacrolimus and pimecrolimus (33). This warning significantly warrants further investigation into the safety of these drugs. In this study topical treatment with a specific .alpha.-MSH formulation had a similar clinical efficacy in the treatment of ACD with a better histological outcome as compared to commercially available tacrolimus ointment (PROTOPIC) in a mouse contact hypersensitivity model. Significant reduction of ACD-induced perivascular lymphocytic infiltrate and dermal edema achieved by betamethasone and .alpha.-MSH was only moderately achieved by PROTOPIC. In 2003 Nishimuta and Ito topically applied PROTOPIC ointment as a clinically-relevant control in a similar mouse contact hypersensitivity model and demonstrated that it moderately suppressed immediate and late phase ear edema reactions in ovalbumin-sensitized mice (34). In 2005 Bhol and Schechter also topically applied PROTOPIC ointment as a control along with the potent steroid halobetasol in a DNFB-induced contact hypersensitivity mouse model demonstrating an intermediate anti-inflammatory effect of PROTOPIC compared to that of the steroid, substantiating the findings of our current study (35). Since PROTOPIC is a widely used commercial topical therapy for dermatitis, our findings suggest that .alpha.-MSH could have similar or better clinical effectiveness and would be a valuable alternative therapeutic choice in some clinical settings.

This study provides evidence that .alpha.-MSH can be formulated with vehicles and skin-penetration enhancers commonly used in commercial preparations of topical medications to be utilized as an effective topical therapy for inflammatory skin reactions such as allergic contact dermatitis. We demonstrate that a highly effective formulation (0.25% .alpha.-MSH with 50% TRANSCUTOL and 10% NMP in water) performs at least as well as PROTOPIC in a widely accepted murine contact hypersensitivity model when applied topically after inflammation has already begun. We suggest that .alpha.-MSH is also a suitable peptide for penetrating the skin barrier in humans to deliver local anti-inflammatory effects when prepared with an ideal combination of excipients. This study is the first to employ topical treatment of full-length .alpha.-MSH in a clinically-relevant timeline to demonstrate effectiveness in the treatment of skin inflammation with the initiation of application following symptomatic presentation."


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endymion96
Posted on: Oct 10 2014, 03:06 AM


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Posts: 361

I found some interesting results after doing a patent search today ... here is a US patent that was granted on 30 SEP 2014. Any thoughts from the peanut gallery?

US 8,846,616 B1
Alpha-melanocyte stimulating hormone as topical anti-inflammatory agent for the treatment of allergic contact dermatitis and eczema


www.uspto.gov/web/patents/patog/week39/OG/html/1406-5/US08846616-20140930.html
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endymion96
Posted on: Oct 1 2014, 05:44 AM


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Posts: 361

Did anybody see the picture of Rocco Falchetto in the article that he wrote? Although he says he participated in the trial in Switzerland, I would assume with a name like Falchetto, he is of Italian decent, no? At any rate ... if that is so, he has a darker skin than I would have imagined for somebody with EPP? In the picture, he looks very tan. I wonder if this is his normal skin tone? My point is that ... I find it amazing (i.e. wonderful) that somebody who has a dark skin tone already can benefit from a drug like Scenesse! This revelation implies that the drug is having an affect beyond that of the tanning aspect. This of course is something we already knew, but it is great to have concrete affirmation. It should bolster the proponents, investors, and patients that this drug is the real deal.


http://www.novartis.com/newsroom/feature-s...g-in-fear.shtml
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endymion96
Posted on: Sep 30 2014, 12:00 PM


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Yes, but my today starts tomorrow when the Bank of New York opens ...
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endymion96
Posted on: Sep 30 2014, 11:48 AM


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Posts: 361

Small request mates ... can you all stop buying until tomorrow? My brokerage check just cleared. Thanks! sad.gif
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endymion96
Posted on: Sep 26 2014, 12:19 PM


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Posts: 361

What do you think of the sellers at this point? Would you sell so close to a final opinion with all signs looking good? After 10 long years of waiting? This is not the longs doing this. Makes me wonder what kind of ride we all will take after approval? I think it will be similar to what we have just witnessed. Until our little secret gets out to a wider base, we are open to the vagaries of the quick hitters.
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endymion96
Posted on: Aug 19 2014, 04:22 AM


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Posts: 361

I agree. In time, these regulators will realize that the protection this drug affords the fair-skinned people of the world is not just a novelty, but a true life-saving treatment. To ask them to avoid the sun as a defense is akin to asking them not to breathe so hard. Its a stupid thing to say. Avoiding the sun is a similarly stupid request.
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endymion96
Posted on: Aug 15 2014, 02:15 PM


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Posts: 361

I said back in 2006 that I'm going down with the ship if it comes to that. No way would any of us long-term holders sell out now. Who cares about balance. I've always invested in this company because of the product. I proved it to myself years ago when I got my hands on it and experimented with it. After an appropriate course .. full sun, noon to 4pm, mid-summer, no SPF lotion, no burn! Winner. That was it. And that's all new investors need to know, unless you want to play roulette with no zero .. but what is the fun in that?
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endymion96
Posted on: Mar 29 2014, 05:50 AM


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Posts: 361

I wonder .. if this drug ever gets approved and the shareprice needle moves straight north .. how many of us will sell immediately and be done with this long slog .. and how many of us will wait for the leveling-out and a potential steady move upward as word gets out? I couldn't tell you what I will do if we ever get to that point. I would be shocked that it even happened .. I've been waiting so long for anything to happen .. deer in the headlights.
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endymion96
Posted on: Oct 29 2012, 03:41 PM


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Is it time to wake up from my slumber yet? Months to go before approval, eh? OK, going back under. Sheesh.
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endymion96
Posted on: Jun 7 2011, 06:30 AM


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Posts: 361

Note that these new drugs are "after-the-fact" treatments. Scenesse still reigns supreme as a "preventative" drug for high-risk individuals.
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endymion96
Posted on: Jun 7 2011, 06:28 AM


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Posts: 361

The news on the two new melanoma drugs are exploding in the media right now .. I just heard an ABC news report on the radio. Yervoy to me, does not seem that great. Vemurafenib seems very promising as it cuts off the melanoma from uncontrolled-tumor growth. Here are some more links.

http://www.abc.net.au/news/stories/2011/06/06/3236836.htm

http://pharmastrategyblog.com/tag/vemurafenib/

http://www.pharmaceutical-networking.com/v...ed-skin-cancer/

http://www.nasdaq.com/aspx/stock-market-ne...reated-patients
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endymion96
Posted on: Jan 20 2010, 02:23 AM


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Posts: 361

There are millions of people who are fair-skinned. The act of walking around town or driving in a car for a few hours with the window rolled down in summer sun is enough to give the face, arms, chest, and neck a good burn. In the winter, just being out in the cold will red up the face and cause hot flashes. For those of you lucky enough not to have fair-skin, you cannot know what it is like to go through life like this. This drug is a god-send for these people. And for those with the rare skin conditions which this drug addresses, I'd say life-altering.

Dr. Wally is no doctor. If he is then he is completely ignorant of the research that has gone into this drug .. not somebody I would trust with my health. But, I tend to agree with the rest of you. That had to be one of the old-timers posting for effect and a laugh.
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endymion96
Posted on: Dec 12 2008, 06:48 AM


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Posts: 361

In reply to: vandango on Tuesday 09/12/08 12:28pm

That article is upsetting because the people they used for their man-on-the-street interviews are not credible. This in turn is mis-representing the product .. they are also blurring both MT-II and afemelanotide which is confusing to somebody who does not know any better.

For certain, you will NOT develop a tan in a week as one girl claimed. At least not from MT-II derived melanosomes. They take at least 3 weeks to develop from point zero. The other thing is - when you are dealing with injections you MUST use very small doses or you will develop these side-effects they speak of. That is why the slow-dose injectable implants were developed.

At any rate, its articles like these and people like the ones mentioned in them that could give afemelanotide a bad and undeserving rap.
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endymion96
Posted on: Dec 9 2008, 09:58 AM


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Posts: 361

In reply to: lfalona on Monday 08/12/08 09:16pm

I was extremely skeptical of what this drug could do years ago .. that was my prime motivation for becoming educated in Biochemistry, Dermatology, and Immunology. While I do not hold PhDs on the subjects, I have focused all of my research into this one drug and its effects inside the body and out. To me its just facinating. I went so far as to order the stuff from a bonified US lab and test it out. Since that time I have been monitoring others and gathering experimental data.

The reason why I am still here after all these years is because I know the drug works and it know it can work safely. I'm just waiting for the dominos to fall and hope nobody screws it up from here on out. But it has been a long wait ... and we still carry that risk.

As for the monkey analogy, I'd swap out monkeys for gold bars. I know what I'm holding .. so I'll just keep patiently waiting for the man to return.
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endymion96
Posted on: Dec 4 2008, 08:51 AM


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In reply to: uhohinc on Tuesday 02/12/08 09:30pm

In my opinion, the trial was not as successful as it could have been for two reasons .. first, it takes time for the drug to actually create an effect in the melanosomes produced. This drug stimulates melanocytes as if the body were actually creating the proper hormone itself - hence it works in a natural progression. Eumelanin takes somewhere around 3-4 weeks to develop. So the first month of test data would be useless. The second month is where you will see some real differences. However, in my experience, 20mg in 10 days is too short of a a time period and too small of a dose to get a really good effect. That dose is barely on the cusp of what is needed for the average person to create a good protection barrier and have the proper internal effect. I would lengthen the amount of time the drug is dispersed and increase the dose .. perhaps have two injections one at the start of each month .. and then record data at say day 40-45.
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endymion96
Posted on: Dec 1 2008, 01:53 PM


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In reply to: Lompid on Wednesday 26/11/08 05:00am

I wonder if the reason why it is so important to tie afamelanotide in with organ transplant patients is because .. if Clinuvel can get this indication passed then it would be a short hop to getting it approved for Fitzpatrick Type-I's .. whom basically have about as much protection as any transplant patient from melanoma. And from there .. hmmm? Commercial market?
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endymion96
Posted on: Nov 21 2008, 04:08 AM


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In reply to: Lompid on Thursday 20/11/08 01:22pm

Well, obviously unless the substance has been approved and regulated by the governing medical organizations - they will pan it harshly. They do not want the public using any substance that has not been tested and approved through proper channels and review boards .. especially the injectable kind.

Although technically, what the guy said is not true - jounalists don't have the background to report the accurate picture. Melanotan (a.k.a. MT-II) did go through at least Phase I trials and was proved to be non-toxic to humans. However, if taken in large doses over a short period of time, the user will suffer some unpleasant side-effects .. if you really go overboard, even anaphalactic shock is possible in some body chemistries. So if experimentation is going on - it must be approached with extreme forethought and knowledge of what you are doing.

However, Afemelanotide (a.k.a. MT-I) is a completely different peptide which is much less broad in its systemic effects. Its action on the one receptor that stimulates eumelanin is very specifically targeted which means side-effects are very muted compared to MT-II. And as we all know - Clinuvel is Phase-III with this drug.
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endymion96
Posted on: Nov 14 2008, 07:22 AM


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QUOTE (rabbitrun @ Friday 14/11/08 06:27am)

Don't get me wrong - I am very frustrated. Its just at what point does my frustration overcome my belief that the product will eventually succeed? The way I'm coming at this is matter-of-fact .. not trying to state opinion one way or the other, but just pointing out what could be happening behind the scenes.

My philosphy is truly fair but very harsh for foolhardy mistakes. I believe if you play this game of not filling us shareholders in on what is really happening and then you fail because of it - you should pay a very significant price .. and that means going to jail. If you did fill us in on progress and let us make an informed decision of how our money should be invested - then you are clear of any responsibility in the case of failure. Since they seem to want to play it out like the former model - let the chips fall brother.
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endymion96
Posted on: Nov 14 2008, 06:14 AM


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In reply to: rabbitrun on Friday 14/11/08 05:54am

They seem to want to make the public read into what is not being said, than fess up about current progress. The fact that they are keeping mum and swtiching strategies is either a very smart decision or a lack of understanding or dismissal of, about, and for their shareholders. I tend to think they would rather not reveal their stategy than the latter .. you know the old saying .. it is better to do now and ask for forgiveness later.
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endymion96
Posted on: Nov 14 2008, 05:45 AM


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From what I've been reading .. Gall Bladder cancer is a Carcinoma meaning it develops in tissues of the skin (epithelial cells), specifically in the inner-most layers of tissue of the Gall Bladder (bile duct epithelium).

A major cause of the cancer seems to be chronic inflammation caused by gallstone formation. Since we know afamelanotide is an anti-inflammatory .. it appears there could be a real chance that this new indication has merit.
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endymion96
Posted on: Nov 11 2008, 03:10 AM


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In reply to: panguna on Sunday 09/11/08 10:07am

That article was frightening. Wow ... I'm really hopeful that in 15 years time after Afamelanotide comes out they would take another a census of skin cancer diagnoses .. and find that the total has significantly declined. I believe it will despite the approved future indications, but unfortunately "sunburn" is not a medical indication, right? I think the FDA needs to rethink their position on this drug in terms of long-term skin cancer prevention.
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endymion96
Posted on: Oct 28 2008, 06:12 PM


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In reply to: lfalona on Monday 27/10/08 12:18pm

Good post lfalona ...

This article is a reaffirmation of what Clinuvel reported awhile back. Obviously the slow-release implant is superior to the injection. Clinuvel has a lock on that delivery mechanism so competitors are not a threat. Really, the only way to take the drug without worrisome side-effects is to go slow and easy on the dosage. This is why I hold long-term .. the technology is solid. Its a shame that sunburn (protection) is not considered a medical condition worthy of preventing because to those Type I/II's out there, it simply is life-changing.
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endymion96
Posted on: Jun 18 2008, 02:15 AM


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Posts: 361

QUOTE (ad0304s @ Tuesday 17/06/08 02:09pm)

This is not a slam on you but just a general response as to why there's so much frustration built into this stock .. and that is .. for those of us who have been in the stock since years before it was promised to be on the shelves in 2006 (yes, 2006 was promised) .. well we're a little pissed that the information has not been more forthcoming so that we investors might try and shuffle our money around elsewhere to get some kind of ROI instead of having it stagnate for years on false promises.

I'm still in for the long hual, but that is basically where the frustration is coming from.
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endymion96
Posted on: Jan 25 2008, 08:35 AM


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Posts: 361

In reply to: polyphemus on Wednesday 23/01/08 10:15am

Good research Poly ... seems to indicate what I have always believed and that is the company has not attracted many new investors. The ones that have been around have seen 6+ years of time slip by are simply waiting until the product hits the shelves. Mature investors have too much frustration built up in this stock/company. Don't expect much movement until big news comes out.

If anybody has year to year data on the number of investors in this stock, I think that would be really interesting to know. Is this data publically available? I don't know how to get it. We always talk about the top 20 investors, but I think that info would be just as telling.
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endymion96
Posted on: Jan 19 2008, 04:34 AM


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In reply to: Rosewood on Saturday 19/01/08 03:33am

Nope - haven't lost confidence. I was trying to point out that PTN vs. CUV formulations are different; however, based on the same melanocortin peptide core. Its just good to track both companies as the one is going US trials first whereas the other is going Europe trials. But technically speaking, I still don't see a problem with the FDA for CUV based on the delivery mechanism used and the melanocortin receptors affected. Was just floating out the idea that Palatin's trouble might be the cause for the delay at Clinuvel or at least give pause to make sure all the T's are crossed and I's dotted for the IND.
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endymion96
Posted on: Jan 19 2008, 02:01 AM


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Posts: 361

Hi all,

Its been awhile since I posted anything worth reading, but just today I was looking at the share price of Palatin (PTN), Clinuvel's half brother if you will. A few years ago, the SP for that company was up around $3-$4. Now its sitting at $0.30. The drug is "delayed" getting into Phase III due to FDA concerns about risk/benefit.

Palatin's formualtion affects the MC-4R in the brain as well as MC-1R. They need to use a delivery dose that must be administered all-at-once as opposed to a slow-release mechanism of CUV (MC-1R only) and as a result, their trials show mild reactions ... and hence FDA is balking.

As somebody who has investigated this drug, it baffles me why they don't go the small dose, slow delivery route as it will work fairly well that way. But be that as it may, we Clinuvel investors should be very happy to have our drug in Phase III trials in Europe. It is a MAJOR accomplishment. However, Palatin's woes may explain the delay of Clinuvel to apply for the FDA IND. They may be waiting to see what happens to Palatin and hence change their strategy if need be. Of course, this is not something they would want to publically vocalize to their investors.

Here's a blurb from Palatin's website on Bremelanotide ...

Bremelanotide in Men

Bremelanotide has been evaluated in four Phase 2 efficacy studies enrolling more than 1,300 men. Plans to initiate Phase 3 clinical trials have been delayed following responses from the FDA raising serious concerns about the acceptable benefit/risk ratio to support progression into Phase 3 studies. Palatin is reviewing the FDA comments in the overall context of the program in order to determine next steps related to the further development of bremelanotide.

Key Clinical Findings from Phase 2 Studies:

effective in a broad range of patients, including those with severe ED and those non-responsive to sildenafil efficacy in at-home studies is comparable to PDE-5 inhibitors up to 50% of ED patients were restored to a normal level of function co-administration with sildenafil shows superior efficacy.

side effects included:
facial flushing
nausea
aftertaste
post-nasal drip
blood pressure increases


Bremelanotide in Women

Palatin has conducted a Phase 1 study in 32 pre-menopausal women without sexual dysfunction, in which the drug was shown to be safe and well tolerated. A secondary endpoint in this study was the assessment of bremelanotide’s effect on vaginal blood flow. Results showed a significant difference in the increase in vaginal blood flow in subjects treated with bremelanotide versus placebo.

A Phase 2A pilot clinical study evaluating bremelanotide in 18 pre-menopausal women diagnosed with FSD has also been completed with favorable results.

Key Clinical Findings from Phase 2A Study:

patients receiving Bremelanotide reported increases in their levels of sexual desire and genital arousal compared to placebo correlation found between sexual desire and genital arousal in patients receiving Bremelanotide.

side effects were mild, including:
nausea
headache
nasal congestion
A Phase 2 at-home study of bremelanotide in FSD patients has been completed, and the results are being analyzed.
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endymion96
Posted on: Jan 5 2008, 03:18 AM


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Posts: 361

In reply to: Rosewood on Saturday 05/01/08 01:08am

I've come to the conclusion that the SP will not rise significantly until the product is on the market ... so I'm guessing 2 years before I see some ROI ... that is if the current investment base stays put. Only expansion to newbies would push this thing out of 1st gear.

I think the long-time investors are too frsutrated to get excited when future milestones are met that unless we get a wider investment audience, you'll see some selling on good news and traction to high levels will be slow.
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endymion96
Posted on: Aug 31 2007, 02:56 PM


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Posts: 361

Palatin's drug, Bremelanotide is a different synthetic hormone from Clinuvel's synthetic drug, CUV1647. Based not only on shape (one is a linear peptide, the other is cyclic), but also on the number of Amino Acids (one has double the AA's compared to the other) and the binding sites of the drugs (CUV1647 binds mostly to MC-1R, where Bremelanotide is less specific and binds to all of the MC receptors, MC-4R in particular).

The similarity lies in the fact that both synthetic hormones contain the same core set of Amino Acids and both interact with the MC-1R which is the trigger for tanning. Also, both are systemic drugs. But since Bremelanotide interacts with the other MC receptors as well, the user is likely to experience more side effects ... especially at the doses used in the trials for ED.

CUV1647 applied with slow-release delivery methods is far superior and far safer for use. It does not cross the Blood-Brain Barrier very easily and thus it is basically limited to interacting with the MC-1R receptors on the melanocyte cells.

Nasal delivery is an easy way to get Bremelanotide into the blood stream without the use of a needle; however, it is not as efficient as using a needle or implant and so this method of delivery requires more of a dose than would otherwise be necessary. Its also a quick way to get the drug into the brain where it can interact with the MC-4R to cause the libido effects.

So in conclusion, we're really dealing with 2 different drugs. I am not the least bit worried about CUV1647 making it to market. I have been researching this thing since 2002 and would have been the first to pull out my money if I ever thought it would be less than spectacular.
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endymion96
Posted on: Aug 18 2007, 05:41 AM


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Posts: 361

QUOTE (Benjammin @ Saturday 18/08/07 01:36am)

If you compare that to what some people actually pay at a tanning saloon year-round ... its probably cheaper or about the same. But you'll also gain the added benefit of preventing skin cancer, serious burns, and being red-faced during the summer months. I'd take that trade any day and for higher costs.

I think moles are a problem for those who are prone to them. I could look at a person and tell if they are going to get them or not on this stuff. But, with those cases being reported I often wonder how much time those people spend in tanning booths and then sun as well ... and if that isn't more of the cause than the drug.

You really don't need to spend every day getting some sort of UV for this stuff to work ... actually very little to light-moderate exposure is all you need. But many people go extreme ... I read about one guy not even using protective eye-goggles while tanning in the saloon! WTF?

Therefore, take what you read with a grain of salt as some of these reports are not very methodical/scientific. But I agree with Benjammin and his experiences. My experience was no moles at all and freckling was NOT more pronounced at all. In fact, the tan blended my existing freckles to almost hidden.
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endymion96
Posted on: Aug 17 2007, 03:03 PM


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Posts: 361

Don't worry ... the slow-release will be (is) great and actually is the key to getting this drug to the market. Without it, the drug would cause some side-effects. Clinuvel was very smart to grab up all the slow-release patents. Thus it will be KEY when these patents are granted.

I've been holding since 2003 I think ... so what's another 2-3 years? I see no reason why this drug will not pass regulatory approval. Its always been only a matter of time. In theory, I don't care what the day to day SP price is doing because I'm a long holder ... but because from time to time I toy with the idea of selling some percentage of my holdings to make a little profit - I get a bit disheartened to see the SP slip so far down. But oh well ... guess I'll put those thoughts away and wait for salvation to come.
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endymion96
Posted on: Aug 16 2007, 02:13 PM


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My mind is numb from this stock, but I will continue to hold. As I have been saying for years ... this stock will never take off in the Autralian market until the drug hits the shelves. We need new investors who are excited about this company ... if they can establish their buying in a foreign stock market - so much the better. Aussie investors are just toying around at this point. 3 years wait ... oh joy!
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endymion96
Posted on: Jul 26 2007, 12:00 AM


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Posts: 361

In reply to: KRD on Tuesday 24/07/07 02:31am

My opinion, but ... history of CUV says that the SP will not rise rapidly as long-time investors will sell (take-profits) rather than let the SP run to far ahead. Too many false starts have conditioned CUV investors this way. But new investors could change that. I'm keeping my eye on volume. When that changes significantly - we'll see a change in pattern. At that point, its anybody's guess.
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endymion96
Posted on: Jul 13 2007, 12:53 AM


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Why such a high volume yesterday?
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endymion96
Posted on: Jul 10 2007, 07:09 AM


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And yes, this is more than just profit taking ... the reason we're in extreme compression when we should have been expanding is because of the combination of profit taking and dilution of the stock with the recent cash injection to fund more trials. However, in the long run this move will bring the SP up.
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endymion96
Posted on: Jul 10 2007, 07:02 AM


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Posts: 361

My thinking is ... unless we get NEW investors interested in this stock, we will never get a quick, large movement upward. And this is because ... assuming the pool of investors is the same ... we have all become conditioned to setbacks in SP and most will go into profit taking mode on any waft of a run.

I don't think Clinuvel has any particular interest in the SP at this time because they believe they will eventually hit gold with this drug. They are making decisions based on what's best for long-term success and not the SP.

Anybody who's in this stock better be prepared to be in for 2-3 years more at least. As far as predicting goes, my belief is that the SP is behaving like a spring ... pull to hard in the upward direction and it will compress backwards. Push to hard in the negative direction and it will want to expand. The guess is figuring out where the stationary point is ... that is the true market value of the stock.

The hard-core investors in this stock will keep the spring from compressing or expanding to far. The only thing changing this will be NEW investors. When you start seeing signs of new investors joining the fray, you'll see things change.

I think we're in a period of extreme compression and do not see the SP falling too much further, barring any bad news.
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endymion96
Posted on: Jun 30 2007, 01:59 AM


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Posts: 361

QUOTE (traveler @ Friday 29/06/07 11:59pm)

I'd say the market is happy with the latest Wolgen interview and that's why things are on the up, but don't see that kind of rise yet.
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endymion96
Posted on: Jun 27 2007, 04:35 AM


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Posts: 361

In reply to: tanman on Tuesday 26/06/07 03:13pm

maybe in another year or so ... I read it takes 3-5 years sad.gif
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endymion96
Posted on: Jun 26 2007, 04:18 AM


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Posts: 361

Yeah, the problem is that Epitan/Clinuvel is taking so long to get this to market that the original patent on the peptide sequence has run out ... meaning that anybody can manufacture it. But, the only delivery method open to users of a dry peptide is to mix it with solution and inject. The general public will not be open to using needles or keeping up with a schedule of injections. But the fact that there is a certain segment of the population willing to do this does show that this drug will be highly sought after when it gets to market.

The "Ace" that Clinuvel holds is that they have applied for ALL slow-release patents of the drug by every conceivable method possible. This is why it will be a red-letter day when these patents are granted as exclusivity was thru what, 2020?
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endymion96
Posted on: Jun 22 2007, 03:19 AM


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Posts: 361

The last dilution killed forward momentum and with that I think we saw new investors who bought in at the higher levels selling off after the small shockwave ... at a loss probably. So we're back down to the level of the die-hard investors who know the science and are not afraid to be patient.

I don't know about everybody else, but the amount of research piling up on what happens when the MC-1R is activated is truly amazing and beneficial in so many ways ... that its almost a foregone conclusion this drug will be HUGE in the future. I have no doubt about regulatory approval and Clinuvel has locked up the slow-release delivery such that when these patents are granted, we investors and believers in this company will be rewarded with dividends well into the future.

In my five years of researching this drug and the process of melanogenesis, I have not come across anything that would give me any doubt about its usefulness. The only two things negative I have seen were the original cases of reported side-effects with the injection delivery method ... and that is no longer an avenue of pursuit for the company due to the biodegradable implant. The other was the tendency of individuals who have a propensity for moles and lentigines to darken.

The SP will rise when the news spreads about the safety and reliability of the technology. It is my current belief that its mostly Aussie investors that are familiar enough with the company to make an informed investment and stay put. But that view is changing as more dermatologists and regular folks become aware of the drug elsewhere in the world. The tipping point is still a guessing game though.
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