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LevelHeaded2000
Posted on: Dec 4 2019, 04:12 PM


Group: Member
Posts: 536

Everything I said is true. I clearly stated it is a full agonist, but due to the implant it does not fully bind all the time despite being a full agonist, which can reduce the melanogensis effect (tanning), so in-effect it is like a partial-agonist (does not reach maximal effect). Clinuvel agrees with me which is why they increased frequency of the implant in the Vitiligo trials to once every 28 days. I clearly stated the solution to this problem. The very solution that Clinuvel itself has acknowledged.


QUOTE
let us discuss the company we have invested in.

My post was in reply to posts talking about Tanabe MT-7117 and posts giving incomplete comparisons as they failed to compare the effect of the drug delivery mechanism in the ability-over-time to bind to MC1R. As such, my post is very relevant to provide additional clarity and accuracy in this issue. My post provided further information on Scenesse. It is relevant in all ways even if you don't want to hear it.


You can personally attack me all you want, but I will continue to provide truth for those still wanting to hear the truth. I post the good, the bad, and the ugly. What I never post is misinformation unlike many on the board and if I do accidentally, then I will correct it and admit it.
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LevelHeaded2000
Posted on: Dec 4 2019, 03:31 PM


Group: Member
Posts: 536

Scenesse functions as a partial agonist in-effect at current implant frequency even if afamelanotide is a full agonist. MT-7117 we don't know if it is a full or partial agonist. Here is some answers to misconceptions:

Does Scenesse and MT-7117 cause a tan and how does it differ?
Yes, both cause a tan. Both are agonists on the MC1R receptor, which is the pathway that causes a tan. Afamelanotide is a full agonist however Scenesse does not cause maximum tanning effect as-is (without much more frequent doseage). Anecdotes aside we don't know about MT-7117 we will have to see. If MT-7117 is a full agonist, then it will have greater tanning effect than Scenesse (explained below) and if it is a partial agonist then it could have anywhere from less to greater affect depending on Scenesse doseage frequency.

Why does Scenesse not cause a full tanning effect / photoprotection if its a full agonist?

It is not due to being a full or partial agonist. It is due the pharmacokinetics of the implant. Drug delivery is as important as the drug being delivered. The implant dumps medicine in the blood in 2 days. By day 10 anyone taking Scenesse is not receiving medicine. The effect of this is that even though it is a full agonist the receptor is only being bound part of the time. The end result is that it is effectively a partial agonist. You can actually see this in the Vitiligo trials (click here) where the implant frequency had to increased to once a month to improve the binding.

Is there a solution to this problem? Yes, more frequent implantation. You can see in the Vitiligo trial they felt they needed at least monthly implantation for improved effect. Given the pharmacokinetics maximum effect would likely need to be at least bi-weekly. This could also effect side-effects though.


Is Scenesse likely to have fewer side effects?
Yes, most likely. In general small molecules (MT-7117) have a higher propensity to have more side effects than peptides (Scenesse). However, this is not guaranteed. MT-7117 has better dosing consistency than Scenesse. Remember Scenesse dumps a large amount of drugs into the body and then after 10 days there is no drug in the blood stream. This results in large changes in drug dosing. MT-7117 will have more consistent day-to-day dosing, so that may reduce some of the side effects. We will have to see what happens with the trials.
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LevelHeaded2000
Posted on: Dec 4 2019, 03:25 AM


Group: Member
Posts: 536

You have identified 4 promised actions by management that failed to materialize in any way. Very interesting post. I have not cross-checked all your info, but it does match up with my memory as I also feel like management has announced many new "products" or "initiatives" many of them have even had a timeline and then we never hear about it again (lies).

The software industry calls this vaporware. It is basically announcing things in order to maintain interest / generate buzz, but without any ability or interest to release the said product. I hope that in 2020 Clinuvel actually achieves milestones and we are not left with more vaporware. If it does, then great things are on the horizon. If Clinuvel continues to execute as in the past, the it will be more pain. I hope we do get an update soon that includes not what they will do, but what they have already done.
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LevelHeaded2000
Posted on: Dec 4 2019, 03:09 AM


Group: Member
Posts: 536

That would be fairly accurate if Tanabe disappears though I would make some minor adjustments now even if Tanabe disappeared. Tanabe finishing phase 2 trials and having apparent good results (though there may be caveats we will have to see) changes that analysis in fundamental ways as you can imagine and that occurred after that post was written. New information changes analysis.

Even if Tanabe disappeared that post was largely based on net-income improvement due to no R&D increases. Net-income is likely to go negative or at least not grow much. Improvement will instead be in revenue only. The reason for this is Clinuvel appears to want to advance it's pre-clinical work (costs $, reduces income).

Summary Changes to Analysis Based on New Information:
  1. Tanabe could if approved alter substantially all future revenue (reduction). If they split the market it would basically mean half the revenue that was the prior potential (actually less than half as margins will likely squeeze) and could even cause shareholder dilution due if Clinuvel still pursued R&D in it's pipeline.
  2. Even if Tanabe disappears all net-income references in that analysis would be different and potentially negative. The reason for this is that Clinuvel must advance it's pre-clinical programs. The advancement of these pre-clinical programs will cause large increases in costs. There of course would still be growth in revenues.

Regardless, if Tanabe failed then the future is still quite bright even if net-income goes down due to advancing R&D (hopefully that leads to more income later).
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LevelHeaded2000
Posted on: Dec 4 2019, 01:11 AM


Group: Member
Posts: 536

I posted that simply because I believe that was Clinuvel's original exit plan and not because I think an acquisition is likely to come to pass. I personally think it will be very hard to find an acquirer at current time. The advancement of Tanabe makes any acquisition too hard to evaluate from an acquirers perspective -- way too much undefined risk. If Tanabe failed due to some huge issue in their trials, then acquisition could be on the table again. Until then, I think any acquirer would require a much lower price than any of us would want in order to be interested.

Until that time Clinuvel needs to execute on every front: rollout, R&D spend, communication with investors, etc.
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LevelHeaded2000
Posted on: Dec 3 2019, 03:28 PM


Group: Member
Posts: 536

QUOTE
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?

I do not think it is too harsh and I have a personal theory. I believe Clinuvel's game plan was to get acquired after FDA approval. Hear me out for the evidence based on some events that seem hard to explain otherwise:

Evidences for this:
  1. Clinuvel stopped investing in R&D. For example CUV9900 and VLRX001 have been with the company for 5+ years and there is no trial on safety / efficacy or anything. $0 in clinical R&D investment. Why? It's better to sell the unlimited potential than invest in R&D and potentially narrow the scope
  2. Clinuvel fails to deliver any hard timelines that is because it hopes to someone else will be the one to do all this stuff after acquisition
  3. Remember "Clinuvel 2020" plan? The plan from years ago that basically talked about everyone leaving the organization and passing the torch. Stan already left. Seems very strange that everyone wants to leave after the FDA approval. Of course, PW ended up staying with a big bribe. Stan did leave. But, the entire "Clinuvel 2020" plan seemed very bizarre to me when I read it years ago and seemed to me to be a company that wants to get acquired and not delivery value on the IP themselves.
  4. Promising very "high-potential" things and then not having any action towards them looks to me like they are trying to increase perception of "potential" for their assets prior to a sell. When selling a business you always make the potential "unlimited" and then diminish the risk. That way you get highest price and hope the other party misprices the risk.
  5. Even doing everything "in-house" indicates wanting to be acquired. If they did licenses, etc, it would put limitations on their IP that a potential acquisition suitor may not like.
  6. The performance rights plan has an "acquisition" poison pill in it.

This is obviously all speculation on thin evidence. However, to me it does seem the actions of the company point to them wanting to be acquired or at least not being opposed to it. Whether it will happen and at what price they could potentially get is not for me to speculate.
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LevelHeaded2000
Posted on: Dec 3 2019, 02:42 PM


Group: Member
Posts: 536

QUOTE
I've reported his account. I ask more of you to report his account. This worked with ignoramus and shut him up for several months.

Do you not see the insanity of this? I have posted no false information yet you are trying to "shut me down" and cancel / censor me. How scared are you that investors see an alternative perspective? This is quite alarming to me.

This is the same person. Just because I am posting information you do not like does not mean my account has been "hijacked". Regardless, the administrator can easily see the IP address and password has remained the same for a year now. So, very easy for them to know if it was "hijacked".

I view your attempt at censorship downright scary and demonstrates exactly my point. This forum is turning into an echo chamber and cult. Either follow the narrative or GET OUT is the message. Scary!
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LevelHeaded2000
Posted on: Dec 3 2019, 02:27 PM


Group: Member
Posts: 536

QUOTE
Do you know approximately or factually (would be preferable) what year it was that they started and completed their phase1 clinical testing of 7117 please?

I have already provided ample information to investigate their clinical trials. Have a look: clinicaltrials.gov You can also follow along on their english version homepage I recommend to bookmark both of them as they are both very relevant to Clinuvel.

Why would you ask me a question you know I have already provided? I can only imagine it is because you want to point out that Tanabe has been developing this drug for years and as such make the point that we should not talk about it today just like we did not talk about it years ago.

As Tanabe develops MT-7117 it becomes more risky for Clinuvel. In Phase 1 it was small risk. Now completed Phase 2 with apparent success it is much more risky. Just like Clinuvel got "de-risked" at every stage of it's development so does MT-7117. And, as it becomes de-risked it becomes more and more relevant to Clinuvel. That is why we talk about it now because MT-7117 passed a huge milestone. It was not worth talking about when it was pre-clinical or Phase 1.
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LevelHeaded2000
Posted on: Dec 3 2019, 01:26 PM


Group: Member
Posts: 536

QUOTE
Yep it's an extraordinary bit of timing REALLY DOES BEG A QUESTION OR TWO regarding Levelhead.


This forum has turned into an echo chamber. No one is looking for real due diligence they are only looking to confirm their own biases. Just look how my sourced and factual "negative" posts receive almost no thanks but the most empty, devoid of facts or even false "super positive" posts receive lots of thanks. Anyone who does not "fall in line" with the cult is now some malicious shorter? It is insane think about it!

I already posted about some of this and why I have became more skeptical in this post. The amount of effort posters here put into calling out any negative and factual post is alarming. People call me a plant, but what about all of you? Thank about it. I know many of you are very insecure in your investment, so you have to "lash out" at anyone who posts any information that seems negative even if true. My personal view is that we are all better served by having accurate information -- the good, the bad, the ugly.

There are REAL ISSUES at Clinuvel. As investors we need to talk about them. People say I am not saying the positives. That is because 99% of the posts talk about the positives. There is no void or lack of information about the positives, so why would I be yet-another-cheerleader? I have said several times Clinuvel still has potential. This potential though needs to be tempered with the reality.

Seriously, there are dozens of posters who cheerlead Clinuvel on this forum. There is basically ONE poster posting factual information that may not be "positive" (me) and sometimes Johnny H and somehow all you treat this like Grade A Threat. If some truthful information that is not positive causes you this much anxiety then there is something wrong with your confidence!
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LevelHeaded2000
Posted on: Dec 3 2019, 01:44 AM


Group: Member
Posts: 536

I only keep talking about the competing drug to Clinuvel (MT-7117) it because a lot misinformation is being posted. If people stopped posting such blatantly false info then I would not have to keep posting as much. 80% of the posts I do about it are due to very misleading info posted by other people. For example:
QUOTE
Is 7117 the same drug and gets around Scenesse's protection? Read the link below. Find the bit that starts "(14) Same drugs means:" and read the detailed scientific jargon and decide for yourself.

Yes, Tanabe's MT-7117 is unequivocally NOT the same drug. It is an entirely different molecule. It is NOT even in the same class of molecules as Scenesse. There is absolutely no dispute or debate on whether it is the same drug. It is NOT.

QUOTE
If 7117 passes the "same drug" test, it has 3 more tests, and it will fail on 1) efficacy and 2) safety, but what about 3) patient care ... Patient care? = No chance (good for CUV).

See, again, misinformation. MT-7117 can pass on ANY of the three criteria. It does NOT need to pass on all. More to the point, since it is NOT the same drug it doesn't even have to pass on one of the criteria.
The one you are talking "patient care" is the most likely way MT-7117 will pass and is basically guaranteed. The FDA specifically points to moving from a non self-administered drug (implant) to a self-administered drug (oral pill) as improving patient care. I don't know if it will show improved efficacy or safety. We will have to see the results.
QUOTE
Oh my God stop talking about this, please.

The reason why it is talked about so much is because tons of misinformation. I am interested in accurate information. That is why I am quoting federal statue, etc. I want accurate data. That way I know my investment decision is optimal. If your investment model depends on inaccurate information, then it is the wrong model.
QUOTE
It's actually probably hurting the stock and even if 7117 gets approved, it'll be years anyway

We can bury our head in the sand and be in denial and believe fake information if we want like the idea that Clinuvel has some type of protection from any competition even from different drugs, but that is not reality. This board is probably 1% of Clinuvel investors. We can create an echo chamber of fake information here, but we only harm ourselves. The other 99% of investors are NOT looking at fake information. They are looking at the hard reality, which is why I am trying to bring to the board by posting information (much of it sourced in legal statute, etc).

It does not matter if MT-7117 is years away. The stock price of a company is a reflection of investor's prediction of it's future potential therefore even if Tanabe is 3 years away it affects the stock price today. THAT is why it is useful to talk about this today because it affects us all as investors, so we should all be informed about the reality.

What is the reality?
  1. Tanabe MT-7117 says they have an effective / safe drug. We don't know for sure, but if it is true, then it will devastate the stock. We will find out how true it is in early 2020.
  2. Clinuvel has no protection from competition from MT-7117 because it is NOT a "same drug" as defined by the FDA. It is a different molecule and even a different class. Even if it was the same drug (it is not) it could still be approved due to the "patient care" provision of the law.
  3. Clinuvel's pre-clinical work is 10+ years away. That's the truth.
  4. If Tanabe disappears, then the sky is the limit for Clinuvel. No doubt about that.
  5. Photoprotection is likely a pie-in-the-sky BS idea to pump the stock, btw. The liklihood of the FDA approving it for that is very slim. This is definitely more towards my opinion than fact. The real path to growing the drug IP that is likely to be understood by the FDA and allowed is through treating identifiable diseases (Vitiligo, HH, AP, etc)
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LevelHeaded2000
Posted on: Dec 3 2019, 01:20 AM


Group: Member
Posts: 536

Did you see how contentious the PW compensation vote was? There were so many "No" votes it could only have reached that number if some of the "large investors" voted No. I think many investors are reaching the tipping point: 1) pre-clinical work going to take a decade 2) rollouts are slow 3) competition quickly coming 4) horizon of patents / exclusivity not long enough to capitalize on the existing IP especially considering the slow rollouts.

To me the CEO letter was pretty desperate sounding. As FarmaZutical mentioned PW had everyone's attention at the AGM just a couple weeks ago and he could have really sold his vision to us. And, he blew it. Now, a few weeks later, we get this strange letter that is talking about "shorting action" as if he is a common poster on Sharecafe. FarmaZutical is right it is comical! Did he mention in the letter than 8% of the share price decline is explained by dilution? Of course not.


PW cares nothing about retail investors. We have seen that time and time again. So, the letter was only spurred because the large investors are showing signs they are looking for the exits. He basically admitted it himself with "profit taking by long term investors". Hopefully he can persuade them to stay for another decade!
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LevelHeaded2000
Posted on: Dec 2 2019, 07:13 PM


Group: Member
Posts: 536

I linked to the federal statue. Your report is from 2004 completely outdated with current statues. There have been many changes in the law since then. In addition, the very link you linked to talks about the necessity to be the same drug. Even in under 2004 laws the oprhan designation only protected same drugs. Different drugs will completely void the exclusivity

QUOTE
The FDA notified Baker Norton that it had determined that Paxene was safe and effective, but could not give final approval until after Taxol’s period of exclusivity. It also stated that Baker Norton could receive final approval for marketing before this date if it could show that Paxene and Taxol are not the same drug

Even in your own outdated link it states that exclusivity is only valid for the same drug. Pay particular attention to the second sentence "could receive final approval for marketing before this date [date of competitor's excluvisity] if it could show ... are not the same drug". I linked to the exact statue in federal law that define what a "same drug" is. There is only so much I can do here, but it is quite clear that Clinuvel has no protection.


Clinuvel's receives no protection from OTHER DRUGS. Tanabe can get approval. That is the law.
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LevelHeaded2000
Posted on: Dec 2 2019, 05:47 PM


Group: Member
Posts: 536

Clinuvel's orphan designation does NOT protect it from competitors and does NOT stop Tanabe. I have posted this before, but it seems these myths keep floating around the board. Accurate information is always the best information. This is not about being "negative" this is simply about being realistic.

The orphan indication only protects someone from competition using the same drug for the same use not someone using a different drug for the same indication. You can see this right in the federal statute on drugs:
QUOTE
Orphan-drug exclusive approval or exclusive approval means that, effective on the date of FDA approval as stated in the approval letter of a marketing application for a sponsor of a designated orphan drug, no approval will be given to a subsequent sponsor of the same drug for the same use or indication for 7 years, except as otherwise provided by law or in this part. A designated drug will receive orphan-drug exclusive approval only if the same drug has not already been approved for the same use or indication


The important part is "of the SAME drug for the SAME use". In addition, let's pretend that Tanabe's MT-7117 was affected by Clinuvel's orphan drug designation (it is NOT), then is it possible for it to still be approved? YES. Here is why:
QUOTE
FDARA Section 607©(2) as “a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care."

Now, one of the very improvements the FDA is looking for under "patient care" is a drug that was previously NOT self-administered (like scenesse implant) being offered as a self-administered drug (such as Tanabe's oral pill).

So, to reiterate, Clinuvel would only receive protection from Tanabe if BOTH the following are true:
  1. The drugs are the same. This is defined in code of federal regulations. You can see it is unlikely that Tanabe, being a completely different molecule would qualify as the "same drug".
  2. If somehow MT-7117 was determined to be the "same drug" it could still be granted approval because it offers an improvement to "patient care" due to it being "self-administered" which the FDA considers highly valuable.

Clinuvel's orphan drug designation does NOT protect it from OTHER DRUGS entering the market for the same indication.
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LevelHeaded2000
Posted on: Dec 2 2019, 01:05 PM


Group: Member
Posts: 536

QUOTE
Get Europe done, doubles sales. Get US Done, that doubles sales. Get some vitiligo access scheme done, 10x sales. If they only could operate in parallel...

There is a real reason why 5 years later in Europe sales are not huge and that reason is not likely to go away quickly. Europe may not be able to double sales for years. It looks like Clinuvel has received a lot of pushback due to not enough efficacy / benefit. Look at Spain, UK, etc. The benefit / cost equation is not high enough for these national healthcare systems that are looking to cut costs in any way possible. My hope is that the UK at least will finally reimburse and I think it will eventually.

US I think has a strong ability to double sales within a few years. And, the Vitiligo / off-label access seems unlikely given the company's communication. Like you I agree with the sentiment. There is possibility here if we had different management that had a more efficient execution style. Unfortunately we just signed a 3 year contract. Maybe we should start a countdown timer for when PW's contract ends?
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LevelHeaded2000
Posted on: Dec 2 2019, 12:36 PM


Group: Member
Posts: 536

QUOTE
Will the other stop loss levels be breached before increased revenues push up the company fundamentals? (and hopefully the share price)

IMO, Q4 will be much better than last years quarter. Not sure how much is priced in because it is pretty obvious Q4 will be good. However, the upcoming trials whenever they start will harm Clinuvel's fundamentals.


Realistically, if Clinuvel finally starts investing in trials / R&D then its net-income could turn negative. If you look at it's actual revenues you will see it's net-income is only positive due to neglecting any type of R&D / pipeline advancement the past 5 years. It's revenues are not huge. It is it's costs that have been cut to the bone that make it have positive net-income. I personally do not view it as bad. Clinuvel has a LOT of catchup R&D to do, so if it keeps cutting R&D then there will never been progress, but it will change it's financial fundamentals considerably when it does start spending again. The risk is no one knows if it's pre-clinical products can pass safety / efficacy.
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LevelHeaded2000
Posted on: Dec 1 2019, 03:02 AM


Group: Member
Posts: 536

QUOTE
P.S supporting your statements with random Google searches in the spur of the moment and coming up with articles from WIRED doesn’t look good. I was expecting some peer reviewed scientific paper but alas, I come across a non scientific article from a somewhat insignificant website that specialises in, electronics perhaps? Give it up shorter.

Sheesh, you really don't read the forum do you? That was not an article I found at all. That was an article posted by another board member which is what spurred this entire discussion you have entered into. At least keep up with the board discussion.
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LevelHeaded2000
Posted on: Dec 1 2019, 02:36 AM


Group: Member
Posts: 536

I have no doubt that their formulations are BS. My point is that no one knows if Clinuvel's formulation is any better as there has been 0 trials on it. Clinuvel created the topical molecule in 2015 and still has no information if the molecule does anything or meets any endpoints. It needs to do clinical work and run trials. After that maybe it will be interesting to someone.
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LevelHeaded2000
Posted on: Dec 1 2019, 02:13 AM


Group: Member
Posts: 536

QUOTE
Cosmetic companies have no actual DNA repair products whatsoever, nor any other company in the world for that matter

Yes, they do. You need to read the articles that people on the forum are posting: https://www.wired.com/story/dna-repairing-s...n-legit-or-nah/

The article clearly talks about many DNA repair enzymes and liposomes that the companies have and put in their products. They have had more clinical work done on them that Clinuvel's topical as that has had zero trials done. So, yes, Estee Lauder is further along than Clinuve in this area. I am not saying the formulations it sells actually has an effect, but the enzymes have had clinical work showing some effect. That is more than can be said for Clinuvel's current topical formulation or even Scenesse for that matter which does not have DNA repair trial yet.
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LevelHeaded2000
Posted on: Dec 1 2019, 12:44 AM


Group: Member
Posts: 536

QUOTE
Selling CUV shares now could be a major financial mistake! PW indicated that EPP is only a proof-of concept and at the same time he has a market cap of $7.5bn in his mind.

Clinuvel has enormous potential. I have never said that Clinuvel does not have the ingredients to become very, very successful given time. If the management learns to multi-task and executes as well as the competition, then this company will soar and the sky is the limit.

At the same time, I don't think the 7.5 billion market cap figure in 3 years is something anybody had in mind and we shouldn't pretend it was a real goal of management. That was a figure created to fool shareholders into voting for that outrageous compensation plan that had the poison pill in it that completely sidesteps the market cap requirement. If management really had that figure in mind, then they would have set it as an objective without the ridiculous poison pill (in fact, two poison pills!).

I personally think Clinuvel will reach 7.5 billion one day if it executes and develops successfully it's pre-clinical IP, but contrary to the people on this board I do not think that day is anywhere close to within the next 3 years.
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LevelHeaded2000
Posted on: Dec 1 2019, 12:32 AM


Group: Member
Posts: 536

It wasn't a negative post. To the contrary, I simply think Clinuvel making the product instead of licensing will be far, far greater profits than licensing it to Estee. Not sure why you got so offended by that idea. Clinuvel should focus on roll out and capture 100% of their profits from the IP.
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LevelHeaded2000
Posted on: Nov 30 2019, 06:47 PM


Group: Member
Posts: 536

QUOTE
Sell the rights to any cosmetic applications to the likes of Esteé Lauder.

What is the value-add for Estee Lauder? According to that article Estee Lauder already has tons of "DNA repair" molecule production and expertise. A cosmetic companies primary value is in their marketing and brand perception. Clinuvel has no well-positioned product in the market. They don't even have a topically applied product that has been shown in a trial to have DNA repair or any therapeutic effect.


In addition, if Estee Lauder is only buying rights, then they would probably demand a very generous deal that would give Clinuvel not much profits considering Estee Lauder already have "dna repair" molecules in their arsenal to check those boxes to consumers. I think Clinuvel would be better off trying to do it on their own at that point so they can capture all the profits. Estee Lauder has too much bargaining power. Just my 2 cents.
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LevelHeaded2000
Posted on: Nov 30 2019, 01:50 PM


Group: Member
Posts: 536

QUOTE
They might not be severe but Scenesse side effects are negligible actually therapeutic.

I agree Scenesse is much more likely to be safer. However, Scenesse DOES have side effects. From the FDA information pamphlet these are the common side effects: implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation


Scenesse is safe. It is not like drinking water though and none of those side effects are "therapeutic". Let's have perspective.

QUOTE
Given the incredible effectiveness of Scenesse, the likelihood of 7117s efficacy even getting close to Scenesse would surely be unlikely.

Reaching Scenesse efficacy is the easy part. Scenesse has had efficacy issues which is why some are refusing to reimburse it and why it had to run so many phase 3 trials. In other words, matching Scenesse for efficacy is a low standard to meet. Meeting the end-point "time in sun" for a broader range than Scenesse's trial indicates MT-7117 may demonstrate more efficacy already.

IMO, MT-7117 will struggle in the safety area and that is a real concern, so we will wait and see on the 2020 data.
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LevelHeaded2000
Posted on: Nov 30 2019, 05:24 AM


Group: Member
Posts: 536

QUOTE
the odds of something going wrong during phase 3 are much much higher than the odds of everything going well. Which makes any obsessive discussion about this medicine completely ridiculous.

I hope this drug fails, but this statement is false in this particular case. In the normal case it could be true, but not in this case. What makes a phase 3 trial fail when phase 2s are successful is the larger patient population. Phase 2's are normally too small to see rare side effects especially. In this case the patient population is already larger than Clinuvel's phase 3 trial. I don't expect the phase 3 to be any larger and due to population size of EPP patients it would not even be possible to be much larger.

Considering Phase 2 deals with dosing it is likely to have the most serious issues in this particular case because there is a chance the Phase 3 trial will utilize the lower of the doses tested in the Phase 2.

My point is that in this case if it passes phase 2 safely then you can almost guarantee it will pass phase 3. As dosing will be same or less as in phase 2 and population will be the about the same.
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LevelHeaded2000
Posted on: Nov 30 2019, 04:12 AM


Group: Member
Posts: 536

QUOTE
The fact that a hepatic function trial is needed is a pretty big red flag in my opinion

I think any drug used for EPP would at this point need a hepatic trial considering that EPP can already lead to liver toxicity and failure. To me the hepatic function trial is not alarming given they said phase 2 had "acceptable safety". They could be lying, but I don't think ANY liver issue with EPP can be considered safe considering the liver issue with EPP patients. If there was a liver issue they would have stopped the trial given the risk IMO. I view the hepatic trial as adding to the body of growing information.

Once they release their data in 2020 if the drug causes liver issues, then it is dead.
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LevelHeaded2000
Posted on: Nov 30 2019, 02:11 AM


Group: Member
Posts: 536

As I already mentioned, there is no hard requirement to show higher efficacy than existing treatments. The FDA will approve a drug based on a placebo comparison only. If you followed my previous posts I included a source that shows 90% of approved treatments do not even perform better than existing treatments.

If the FDA believes a drug has much higher efficacy than existing treatments it can receive Breakthrough Designation and get a faster approval. Otherwise, it will go through the normal drug approval process. Tanabe's MT-7117 already has Fast Track Designation.
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LevelHeaded2000
Posted on: Nov 30 2019, 01:54 AM


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Yes, read my previous post to Johnny. The MT-7117-A01 trial is the phase 2 trial. This is completed. And that was the data I listed. The latest trial which started October and is in recruiting phase is https://clinicaltrials.gov/ct2/show/NCT0411...aw=1&rank=3

You can review all trials associated with the drug here: https://clinicaltrials.gov/ct2/results?term...p;rank=2#rowId1 By clicking the completed Phase 2 trial and looking at it's "Other ID" field you can see it is the same trial that you were referencing from Utah (which has not been updated).

You will notice the latest trial has no strange "exclusions".
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LevelHeaded2000
Posted on: Nov 30 2019, 01:52 AM


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QUOTE
You obviously didn't read the link. This is for PHASE THREE: https://healthcare.utah.edu/clinicaltrials/...p?id=FP00012322

That is incorrect. I respect you as you have made a lot of contribution and I will admit when I am wrong, but there is no phase 3. Tanabe has announced no phase 3 yet.


What you think is a phase 3 is actually the phase 2. You can see this here: https://clinicaltrials.gov/ct2/show/NCT0352...w=1&rank=5Y

You will notice it lists "Other Study ID" field which is "MT-7117-A01" the exact same study you just posted from utah's view of trials.
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LevelHeaded2000
Posted on: Nov 29 2019, 06:43 PM


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QUOTE
How valid are those MT... trials actually now, with Scenesse being approved?

Very valid. Scenesse approval does not affect Tanabe's MT-7117 at all.

QUOTE
Doesn’t a new drug for the same indication need to be proven “better” than the treatment established? Don’t they need to test their pills vs Scenesse in the trials to show better safety and efficacy?

Nope. 90% of drugs approved by the FDA are no better than existing treatments (source). You might be confused with Breakthrough Designation (info). That is for treatments that the FDA deems might be better than existing treatments and they can receive a priority review. Treatments that are not better than existing treatments can still be approved. They simply go through a non-breakthrough process.

Tanabe's MT-7117 already has Fast Track Designation (info)
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LevelHeaded2000
Posted on: Nov 29 2019, 04:58 PM


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QUOTE
From what I can gather for the upcoming trial there are much more strict exclusion criteria compared to Clinuvel's trial... In the above exclusion criteria include medications that affect the gastric pH.

Refer to previous post for detailed analysis, but there is exactly ONE upcoming trial that we know anything about: https://clinicaltrials.gov/ct2/show/NCT0411...aw=1&rank=3

This trial has none of the issues you posted about and is much LESS restrictive. The ONLY trial that lists anything that was relevant in your post was the trial done PRIOR to their bioavailability study. That is how it works. They completed their bioavailibility study and had very good data by appearance. Every trial started AFTER the bio-availability trial has not had these exlusions.
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LevelHeaded2000
Posted on: Nov 29 2019, 04:35 PM


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QUOTE
Interesting. In the last trial, MT-7117 was co-administered with a PPI (proton pump inhibitor), which significantly raises the ph of the stomach. Now, they're trying to avoid raising the ph.

Your statement is very misleading and is meant to create a causal relationship when one does not exist. Here are the actual facts and people can decide:
  1. Trial for bioavailabity under different conditions was run from September 2018 to 2019 testing. Trial is here: https://clinicaltrials.gov/ct2/show/NCT0368...aw=1&rank=2
  2. EPP trial was started May 2018 BEFORE the bioavilability trial. Of course it has strict exclusion on anything that can effect bioavailability as the bioavailability trial had not run! Here is that trial: https://clinicaltrials.gov/ct2/show/NCT0352...aw=1&rank=5
QUOTE
Now, they're trying to avoid raising the ph.

No, they aren't. The ONLY trial they tried to avoid that was a trial conducted PRIOR to their trial on bio-availability. The trial conducted AFTER the bioavailability trial started October 4th, 2019. This trial is listed here: https://clinicaltrials.gov/ct2/show/NCT0411...aw=1&rank=3

You can see that the exclusion criteria is much LESS restrictive. Why? It is the ONLY trial started after the bioavailability trial. Obviously Tanabe's bioavailability trial was a success and there is no concern regarding MT-7117 and absorption. This is what the actual trial events indicate.
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LevelHeaded2000
Posted on: Nov 29 2019, 05:11 AM


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Actually, if you look at my post history I have always been consistent the dilution was bad. I simply said to focus on the larger picture and that 3% was a small price if the larger picture was realized. I made several posts that the recession clause was a poison pill too and I even said I vote NO on it. However, the AGM seems to have included additional dilution to even the dilution that was voted on, so it has gotten worse than from when even those posts were made. And, my awareness on the company's situation has increased since then, so obviously it becomes a bigger deal when I now realize what a bad situation Clinuvel is in.

You seem to be trying to discredit information I talk about by discrediting me. Instead, you should focus on the information and discredit that. The source of who tells information does not change the truth of the information. What exactly is the information you take issue with? Do you disagree that Tanabe having what they claim a safe and effective drug that has finished Phase 2 trials and is Fast Tracked is a threat? Do you disagree that Clinuvel has wasted years puffing up pre-clinical work it actually did not invest him? Do you disagree it takes around 10 years to bring pre-clinical to an approved product?

Attack the information, not the source of the information.

QUOTE
Now you’re a broken record stuck on the MT drug who can’t seem to move on from that. Follow your own advice perhaps?

The dilution event was a one-time event with small impact (3%). Tanabe is an evolving threat with enormous evolving impact. It does not make sense to "move on" from it when it is evolving and when it's implications can make or break Clinuvel.
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LevelHeaded2000
Posted on: Nov 29 2019, 12:38 AM


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QUOTE
What changed? Where are the positives of the SWOT analysis you promised? You have been a great contributor over the years, but the sudden and unfounded apocalyptic view of this company is confounding.

I have been nothing but upfront and continue to be upfront. I declared after the AGM seeing the amatuerish presentation and illusory pie-in-the-sky goals with no action plan I was becoming more and more pessimistic. As of now, I would say it is not pessimism, but realism.

Like many on this board I was amping myself full optimism, full of blind-faith, with a lack of skepticism. Like many on this board every time something bad happened I was excusing, justifying it, closing my eyes to it. You can look at my post history to see this.

I hit a breaking point though. A point where I could no long excuse the delays, the incompetence, the downright theft that this company was committing against us shareholders. Since then, I have been skepitcal. More willing to cross check information. Asking myself more and more questions and the answers I am not liking. Investing is not throwing money at something and praying and holding faith. It is constantly analyzing, questioning, and being open to contrary opinions. I had stopped doing this and I said I will never stop again.

When I looked at Clinuvel with fresh eyes, with skeptical eyes, what I saw a lot of red flags. Many of them I have discussed and some of them I will discuss later. These are things as investors we need to confront, so that we can fully understand what we have been invested in.

Don't say what I am saying has no value. Just in the last few days I have corrected, oftentimes with sources, bad information people have. One example would be the believe that Tanabe (or Clinuvel for that matter) needs to perform 2 phase 3 trials when that is simply not true. By having better information we make better decisions. So, please do not close your mind to any information. Look at it, see if it is false, and if it is then discard it. If it is true, then accept it. If it is a matter of opinion ask yourself if you can see the other person's opinion having value.

QUOTE
One could say you are trying to get cheap shares considering the limited number of shareholders (only 4200) and the sway this board has on some retail investors

I have been called a shorter recently. Now I am called a devious long. There is no way to prove my intention, but I wll say this: No one has shown that any of the primary things I haves said are false. So, if what I am saying has truth to it, do you really think I am trying to shake the tree to get more shares? Not at all.

As for whether I am a short, you can see my post history I was pumping the stock like the rest of you when it was high. THAT was the time to short and drive down the price. If I shorted, I would already be in profit, no need to talk on the forum. And, if I am opening a short now, then I would be very dumb because as you said prices are low. No, I am not a short.

What am I? I am a battered investor. An investor that was lied about OTC launches and RTF. An investor that has seen IP dwindle with no investment or advancement for 5+ years (CUV9900). An investor that has been diluted and stolen from by a malicious management. It doesn't matter what I am as long as I am providing accurate information then I am contributing.

QUOTE
Where are the positives of the SWOT analysis you promised?

My posts have had sprinkles of positives in it. From the fact it's a peptide so likely more safe. To the analysis of the financials that hinted at Q4 being larger than Q4 last year even if Q3 was not. In addition, if Tanabe fails, then the sky is the limit for Clinuvel. No questions. Right now, every post on this forum except mine is filled with positives, so there hasn't been a need for me to stress these things as every other post does. I am more interested in providing the contrary viewpoint. With both viewpoints each investor can make a better decisino.

QUOTE
However, its time to execute and open that US piggybank.

This I fully agree with.
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LevelHeaded2000
Posted on: Nov 28 2019, 05:29 PM


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

The result of Vallaurix was already announced. The Vallaurix entity created VLRX001. This product is the "topical" Clinuvel talks about. It was developed in 2015 (source) and in the last 4 years there has been no trials conducted on this molecule to prove safety / efficacy.


We all know the trial process and how long it takes to go from animal testing to FDA approval. This "topically" applied molecule will not be seen for 10 years and is not what Clinuvel will be releasing for it's "cosmetic" line.

The "cosmetic" products Clinuvel are talking about creating cannot create a tan. It is NOT VLRX001. It will be things that like a Clinuvel branded lotion / sunblock. Products that change skin biology are regulated by the FDA/EMA, etc. This requires going through the 3 phases of trials. Products that can be released in the next year, that avoid the FDA, are limited in their action. It definitely cannot be a transdermal product that causes a hormone to penetrate into the blood stream.

Any "cosmetic" products Clinuvel releases in the next years is a completely different business. No different than someone who puts a label on chinese made lotions and sells them on Amazon. Can it add value? Yes. Is it the photoprotection most people on the forum seem to think? No. The closest to photoprotection it wil be is a sunblock lotion using the standard ingredients approved by the FDA/EMA for cosmetic sunblock lotions.
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LevelHeaded2000
Posted on: Nov 28 2019, 05:32 AM


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QUOTE
You haven’t considered vitiligo or DNA repair as bulwarks to MT’s threat. No, MT will not be able to provide therapy to vitiligo sufferers as they will need adjuvant creams to assist with patchy lesions

Tanabe's MT-7117 has the SAME mechanism of action as Scenesse and therefore will likely be applied for any indication that Scenesse works with. That means Vitiligo, EPP, AP, HH, DNA repair, you name it! Regarding Vitiligo specifically, it will also face some potential competition from reCell though much more minor.

In fact, I have stated before, Vitiligo is a non-continuous treatment and therefore an oral is undebatedly superior because there is no easy way to stop Scenesse. You must take it in multi-months intervals. Whereas an oral can be started and stopped exactly when needed and thus there is no over-medication.

Regarding your "creams" I can only assume you are alluding to Clinuvel's "topical" as that is the only cream relates to Clinuvel. The topical that has not even had animal trials, that is 10 years away from any approval. That is not really relevant. The trial Clinuvel ran on Vitiligo was with it's Scenesse implant. That is the only drug it has prepared currently for Vitiligo and as stated the Tanabe drug has the same mechanism of action.

The primary strength Clinuvel has is Scenesse is a peptide and therefore likely safer. The wildcard of Tanabe is how safe is it? Safe enough for EPP may not be safe enough for photoprotection. We will wait and see what the trial results show.

QUOTE
You haven’t considered Clinuvel’s response to the MT threat, in which all it would take is for PW to allow Scenesse to be used off label, thereby allowing saturation of the US market and providing enormous revenues before MT even get their foot in the door.


How does that even make sense? Tanabe doesn't care if people use Scenesse off-label. "Saturate the market?" Will they only charge $5 for the drug? Insurance does not necessarily cover "off-label" use. In addition, even if they gave away the drug for free it does not matter. They cannot pay people to take the drug, but Tanabe CAN give compensation for trial participation. So, people will still join the trials. All Tanabe needs is ONE indication and it can also do "off-label". In the game of price competition who you think wins? The biotech with one product and small revenues or the ones with diversified products and large revenue?
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LevelHeaded2000
Posted on: Nov 28 2019, 02:50 AM


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QUOTE
The courageous assumption that the FDA would only require one Phase III trial - normally two are needed which puts the timelines for even the possibility of it being a competitor out to 5 years


The FDA only requires one phase 3. Clinuvel did two phase 3's due to incompetence. Their phase 3 did not meet efficacy endpoints and thus it was either end the entire drug program or do another phase 3 and prove some kind of efficacy. Tanabe's trial already met efficacy endpoints (according to Tanabe), so it is unlikely they will have the same issue of incompetence. If the first phase 3 is a success they couldn't really do another phase 3 even if the FDA wanted to. There isn't enough patient population for it. It would just be the same trial with the same patients.


What would be really bad is if Tanabe's drug had higher efficacy. One issue with Scenesse is the very low reported efficacy. That is why they use secondary measures like "drug continuance rate", etc. If Tanabe's shows real efficacy in it's phase 3, then that will be very persuasive to insurance reimbursement, etc.

I am just hoping that safety is an issue. They started a new trial within a month to measure the drug's effect on people with bad livers. EPP affects the liver (3% have liver failure I believe). If this trial shows a safety concern then it could be great for Clinuvel: https://clinicaltrials.gov/ct2/show/NCT0411...aw=2&rank=3
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LevelHeaded2000
Posted on: Nov 28 2019, 01:15 AM


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Tanabe has already trialed about 25-50% of the known EPP population with the MT-7117 drug. They will do a Phase 3 likely with > 100 patients (their phase 2 had 103 patients which is larger that Clinuvel's phase 3).


The patient population already has experience with the drug. 66% of them presumably already got the drug (the trial had 3 groups, so 33% in each group). According to Tanabe's press release it met endpoints in extending time in sun. Since EPP is such a small patient population many of the people in the Phase 2 will be in the Phase 3, too.

So, the question is, why would they NOT do it? Most of them already did it. 66% of them already saw the efficacy if Tanabe's statements can be believed. The drug will be FREE and likely Tanabe will likely give them money for participating. Clinuvel's drug on the other hand will NOT be free for most people. In the US most people will still need to pay a deductible / copay. In addition, ancillary costs (gas to get there, etc) are not paid for by insurance.


Give all this it is likely that at least some of these patients will participate in the phase 3. Obviously if they do, then they cannot be Clinuvel's customers at the same time.
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LevelHeaded2000
Posted on: Nov 27 2019, 10:02 PM


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QUOTE
You’re no longer analysing, you’re jumping at shadows. Are you short?

No longer analyzing? I am perhaps one of the few who is still analyzing whereas most others have turned to sychophants who only cheerlead. I am the one who pointed out that MT-7117 was a small molecule and the implications of that in terms of safety (positive for Clinuvel). I am the one that pointed that the trials will slow down EPP rollout in the US (negative for Clinuvel). I have provided a lot of unique analysis here that is both positive and negative. That is how investment models can be improved and everyone benefits.

Your viewpoint of "analyzing" appears to be cheerleading instead of offering thoughtful perspectives based on the facts at hand. An echo chamber where only "positives" can be said is not useful for investors. If your investment thesis requires ignorance to any threat, then it is probably a weak investment thesis. The problem is other investors do not have their head buried in the sand, so whether you want to hear the "bad news" or not, other investors will be making decisions about it and you will be on the losing end.


The only "shadows" on this board is the boogeyman of the shorter and this delusional "filling the gap" hope. That is not investing. That is gambling.
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LevelHeaded2000
Posted on: Nov 27 2019, 07:05 PM


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QUOTE
The SP will grow on EPP sales now that we have expanded the market

I hope that UK NICE rules positive in favor of Clinuvel and I think it will. Q3 revenues shrunk YoY but I think Q4 will be much larger than 2018. 2019 is on-track to 20% revenue growth compared to last year.

USA rollout I think will be less than stellar though. 25-50% of the patient population will be cannibalized by the MT-7117 clinical trials. However, despite this I expect 2020 revenues to increase overall. On the other hand, I expect 2020 net-income to go negative. That sounds bad, but if it doesn't go negative, then the company is basically dead. Clinuvel has neglected R&D. It has 5+ years touting the same "pre-clinical" pills that have had no R&D advancement in 5+ years. It needs to do actual advancement in next-generation which will cost money or Clinuvel will die due to pipeline starvation.


It takes 10+ years to go from pre-clinical to approval. Clinuvel's next-gen stuff is all 10+ years away. It needs to start working on it TODAY. It's existing stuff doesn't have market exclusivity for long. I believe 7 years for EPP in USA and 5 years in the EU (5 years have already been wasted).
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LevelHeaded2000
Posted on: Nov 26 2019, 09:36 PM


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QUOTE
Why are you so into this drug thats in phase 2 of testing “out of nowhere?”

It's not in phase 2. It has completed phase 2 and they have already announced efficacy and safety meet their targets. Every investor should be "into this drug" because this drug directly affects Clinuvel's future income, market size, and potential.


The drug is not a minor threat. It is a drug that could literally leave Clinuvel's assets stranded. It is an enormous threat. And, people are talking about it now because it completed phase 2 and has Fast Track designation. As they release full data people will talk about it more. As they start phase 3 people will talk about it even more. Every step the drug takes becomes more and more of an existential crisis for Clinuvel.

I do not think ignoring it is wise. We need to talk about it and fully understand in all ways it is a threat. That way we can analyze it's effect on Clinuvel if it progresses.
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LevelHeaded2000
Posted on: Nov 26 2019, 08:13 PM


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Assuming MT-7117 is just as safe and effective, I don't see why anyone would take an implant over a pill.
Agreed. Pills are far more preferable. This is not comparable to a birth control pill and trying to compare this is delusional IMO. An implant is preferable for birth control because even missing a dose by a few hours can result in failure for the entire month and render it completely ineffective. That is the ONLY reason why it is an implant. You will notice almost no other drug is implanted because consumers don't want it and they are dangerous (no ability to easily stop dosing without intervention).


That is not the case with this pill. Exact timing and missed doses are not mission critical. Pills offer huge advantages to consumers. For example, how would someone even go on a 2 month trip to a foreign when their implant expires in the middle? It's impossible! With pills they just throw another pill bottle in their suit case. Easy peasy!Pills also offer dosing advantages in any indication that is non-continuous (Vitiligo) and will likely be the conservative treatment option for any of those conditions.

By the time this threat drug is ready to market, Clinuvel will be streets ahead.
There is a saying in business "He who goes first takes all the arrows". That is what we are seeing here. Clinuvel trail-blazed a pathway and a competitor is following in the same path now that the regulatory body, etc, is already familiar with the concept. Thus, the competitor will have a much easier time thanks to Clinuvel's efforts.


How exactly will Clinuvel get ahead? Tanabe is larger, with more financing, and has an easier distribution / commercialization platform since it is a pill. Sure, Clinuvel can work to prove more indications and that will give them a 6-12 month lead. And then BAM, Tanabe will just apply for the same indications as their drug has the same mechanism of action. Given off-label use in the US a doctor could just give patients the Tanabe pills for indications that Clinuvel is approved for.
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LevelHeaded2000
Posted on: Nov 26 2019, 08:05 PM


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Any efficacy and safety data published? You said they were more than 100 in the trail, so would like to see data from that before any big speculation
The trial met all end points and demonstrated safety according to the press release. The actual full trial data discussion will be done in early 2020 at conference. The release can be seen here: https://www.porphyriafoundation.org/about-t...oporphyria-epp/

Something is not right here. �' The first Ive heard about this drug is in 2019
The drug has been under active development and has been fast tracked by the FDA. It is all public and it didn't come "out of nowhere". You are hearing about it more because it is being de-risked. A year ago it seemed unlikely to go anywhere. Now the new trial finished and it is a huge threat. This may be the reason for the shorts. Imagine everyone involved with the drug will know how this affects Clinuvel, so shorting may seem like easy money. You can see the clinical trials here: https://clinicaltrials.gov/ct2/results?term...aw=2&rank=3


After the conference in early 2020 you will be hearing about it a LOT more. That is how it works. As more info becomes available more people talk about it. We are just talking about it now. In a couple months even the most casual Clinuvel investor will become aware of it due to all the press releases Tanabe will do. That's why it is important we discuss it now before it becomes even more general knowledge.
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LevelHeaded2000
Posted on: Nov 26 2019, 03:58 PM


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Here are my viewpoints to the questions:

This MT drug from Mitsubishi Tanabe, can it be used to treat variagate porphyria? What about XP? I understand it’s a partial MC1 agonist
IMO, it will work for any indication Scenesse will work as it has the same mechanism of action. The drug seems to cause melanogenesis and has immunomodulatory properties. In my opinion it all comes down to safety. This is where there could be product differentiation and Scenesse has the advantage. Keep in mind their phase 2 had more patients in it than Clinuvel's phase 3. They are not lacking data and they are satisfied with both efficacy and safety. The degree to which it is an MC1R agnoist is speculation. I haven't seen data yet and it will probably be presented in early 2020, but the apearance is that "it works good enough". I am just hoping some safety issue comes up.

What am I missing here that CUV will somehow lose potential sales for the period the enrolment in the trial was happening?
Any patients enrolled in Tanabe's trial is a lost sale. It would be great if they failed to have any patients enroll in a trial, but I think it is fantasy. There are many reasons why a patient would choose to enroll in this clniical trial:
  1. Not all insurance companies will have a reimbursement plan ready. Phase 3 could realistically start early 2020. That is very soon.
  2. In the US treatment usually is not "free" even for people with born illness (I know as my brother has one!). They must first reach a certain spend a year and then they may be responsible for a certain % going forward.
  3. Even if someone had some platinum insurance plan where treatment is 100% free the ancillary costs are not free. The cost to drive 100 miles to the nearest treatment center is not free, etc. In a clinical trial the participants usually are provided compensation.
  4. Even if money is no object some people would prefer not to have an implant and get scarred. An oral drug is simply more convenient. They likely would have been implanted, but if they can help move forward a drug that requires no implantation and it only means they have a 50% chance of getting a placebo, then why not? Not everyone with EPP are the worst cases you see on TV. Many have learned to live with the disease quite well and are not in "desperate" need.
I think the results of the phase 2 will determine a lot too. If there is a safety concern, then I imagine people will say no and not participate. If efficacy is bad, then same. However, if efficacy is better then scenesse, then that will give them more motivation.

Remember, there were lots of problems running Clinuvel's trials. Now, patients, etc, are aware of that. It is possible that efficacy of Tanabe's drug will be better than Clinuvels simply due to patient awareness and better run trials.

Isn't it a long way off if it's only in phase 2 test? Thats donkeys years away even if it does succeed isn't it?

We are all too used to have slow Clinuvel does things. A real pharma company can do it quite rapidly. They are already in discussion with the FDA and have Fast Track status, so I imagine the delays between phase 3 finishing, FDA submittal and communication, and approval will be compressed. It won't be like Clinuvel that took 3 years after EMA approval to even contact the FDA.
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LevelHeaded2000
Posted on: Nov 26 2019, 03:02 PM


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Hard to say but likely late 2021 or early 2022. Tanabe have Fast Track FDA status on the drug competitor to Clinuvel. They just need to run the phase 3 trial. I think the following is more important:

When does Tanabe's MT-7117 start affecting share price and income?

This comes much sooner even if it does not get approved until 2022. Each milestone of Tanabe's drug will cause investors to de-risk it and attribute more and more risk to Clinuvel's cashflows. The presentation that Tanabe gives in early 2020 could be real bad news event for Clinuvel depending on the data presented. In addition, as pointed out by Johnny H, Tanabe's MT7117 will interfere with Clinuvel's USA rollout TODAY.

In other words, it has already reduced Clinuvel's income potential in the US for the next years. In the FDA communication with Clinuvel I believe they said there are 200 identified EPP patients and they expect "no more than 400".

Tanabe's phase 3 trial will be likely 100+ people. So, if 100 people are enrolled in Tanabe's phase 3, then that is 100 patients or 25-50% of the market that cannot take Scenesse. Their phase 2 had 102 people (more than Clinuvel's phase 3 btw), so I can only imagine the phase 3 will be even more. This will cannibalize sales from Clinuvel even though Tanabe's drug is not yet approved
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LevelHeaded2000
Posted on: Nov 26 2019, 12:53 AM


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Clinuvel requested a Type-C meeting with the FDA. I think that takes about 3 months, so there won't be any news until then. After that they will need to fully plan and execute on whatever trials the FDA recommends to them. My guess is Vitiligo trials will start in the second half of 2020 (assuming Clinuvel executes efficiently otherwise it could be 2021).
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LevelHeaded2000
Posted on: Nov 25 2019, 11:05 PM


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Yes, the reCell's method has some limitations and so does Clinuvel's, so I guess it depends on each patient case. For example, Clinuvel's drug is for darker skinned patients, so anyone who is not darker skinned will likely gravitate towards reCell's treatment.

A typical re-cell biopsy of 1 cm2 can treat an area that 80cm2 per-session. My guess is reCell would be the first choice for feet, hands, and face and for anyone with skin complexion that was lighter. These are probably the most concerning areas to people because they are the most visible. An MC1R based drug would be the first choice for larger areas, darker skinned people, and anyone that did not respond to reCell of course.


It should be noted that there are quite a lot of people that did not get fully cured by reCell's or Clinuvel's treatment. So, as noted by PunkAssDerm, someone that wants to be fully cured will ilkely have to try a combination of treatments each one (hopefully) amplifying the other.


The question is which MC1R based drug is more suitable? I am not sure Sceness will be the MC1R drug of choice for Vitiligo. Tanabe's MT-7117 drug, assuming it gets approved which is an IF, would likely be a doctors first choice. For the following reasons:
  1. No implantation / scarring
  2. Easy to stop if there is any adverse event (more conservative)
  3. Related to #2 there is no over-medicating. With scenesse the doctor has to give a drug in 3 months intervals even if it does not fit the treatment plan. With Tanabe's the patients can take it for 4 months. Exactly what they need. No need for an additional 2 months of medication.

Unless MT-7117 has some material safety concern, which is still very possible, then it seems like it would be the first choice for any non-continuous use of the drug.
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LevelHeaded2000
Posted on: Nov 25 2019, 10:49 PM


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Yes, it should tan the skin. It is an MC1R agonist just like Scenesse, so it should have similar effects as far as MC1R is concerned, which is the pathway that causes the tanning.
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LevelHeaded2000
Posted on: Nov 25 2019, 01:11 AM


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Threats / Weakness Analysis
Starting with Threats in the SWOT analysis previously mentioned here is my threat post and it will be followed up with a strength / opp post later. First the bad news, then the good news.

The primary threat facing Clinuvel is time. It's patent is running out. It has market exclusivity for EPP, but competitors are releasing medicine for EPP, so it might not matter. The other molecules have not even had animal testing done on them yet, so we cannot even know if there is safety / efficacy concerns. There has not been any R&D done and when R&D does happen it will cut into profits. Consider them 5+ years out.

Threats Clinuvel Faces on Every Indication it is Targeting (including photoprotection)

Mitsubishi Tanabe is closing in on Clinuvel with a molecule that targets the exact same receptor for the exact same effect, but it is a much more convenient delivery method. One that can be easily stopped if there is any adverse event or easily tweaked in the dosing. It is an oral once a day pill. This is a well-financed pharma company that knows how to execute. We can view the publicly registered trials here: https://clinicaltrials.gov/ct2/results?term=MT-7117

Mitsubish Tanabe has fast track with the FDA and they appear very serious about their drug. You can see they are performing a lot of general safety trials including efficacy trials for EPP. They say they will be releasing public results in very early 2020 so it is months away. They have received Fast Track designation at the FDA.

Risk: IF Tanabe is successful it will gut the market for Clinuvel. A pill is easier to distribute and commercialize and I guarantee most consumers would rather get a pill delivered to their house rather than traveling 100 miles to a treatment center to receive an implant and taking a day off work. A pillbox will be faster to commercialize for any indication. Because MT--7117 works on the same receptor as Scenesse then any indication that Scenesse can target can also be targeted by MT-7117.

It is my belief that this and patents is why Clinuvel shifted gears from Vitiligo and started talking about Photoprotection. Obviously, a short-term adjunct treatment would be better benefited by a more time-controlled doseage that a pill offers. Thus, MT-7117 would be much better suited to any non-continuous treatment plan from any doctor perspective (an implant that does not allow specific dosing will over-medicate versus a pill that can be taken only during the specific time of the UVB treatment). So, my point being, if this gets approved it would wipe out Clinuvel's Vitiligo market probably close to 100% as a pill is much more suitable to any non-continuous treatment.

Hope: There is hope that MT-7117 is not safe enough. MT-7117 is a small molecule whereas Scenesse is a peptide. Peptide's are larger which is why Scenesse cannot penetrate the skin for example (and why they use a different molecule for this). A good consequence of this is that it tends to have less undesirable interactions in the body. A small molecule is much more likely to bind to other unintended receptors in the body and thus cause more side effects. There is hope that MT-7117 won't have a good safety profile. However, considering the number of safety trials Tanabe is conducting and there statement that safety has been no issue it makes less optimistic. It's possible MT-7117 could be safe enough for some indications, but not safe enough for generalized photoprotection. That is some hope.


Continued in post below...
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LevelHeaded2000
Posted on: Nov 25 2019, 01:10 AM


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Threats Clinuvel Faces on Vitiligo

Another reason why I think Clinuvel de-emphasized Vitiligo in place of photoprotection is that a new competitor is about to enter the Vitiligo space, IMO. That would be none other than Avita Medical, a darling talked about on this forum, which just received 100M+ to conduct further R&D. It seems obvious they will be pursuing Vitiligo in the near-ish future: https://avitamedical.com/evidence-vitiligo and https://avitamedical.com/uploads/pdf/AVH-Pr...019-FINAL-B.pdf

Clinuvel's Vitiligo treatment is only an adjunct treatment for patients that would benefit from UVB treatment. It is only for patients of darker skin color and not suitable for lighter skin colors. The evidence thus far does not suggest autologous epidermal cells (reCell) is a cure. 80% of patients showed good response in repigmentation and 17% of those showed basically complete repigmentation, so there are some "tough responders" that would need another treatment. This is without any exposure to harmful UVB though so it would likely be a first-level treatment. This can target people of light or dark skin. So, there would still be room for Clinuvel's treatment however it would shrink Clinuvel's potential market size in Vitiligo and reduce the future profit expectations investors have for Clinuvel.

Threat of Management

Of course, everyone is well aware of this. Clinuvel is diluting the company at 3% it appears. In addition, they have failed to re-invest in R&D. The result of this means the income looks higher than it should be because they got it so high borrowing from the past. As soon as they invest in R&D again to try to commercialize their most recently patented molecules, then income will fall considerably. Incompetent, slow management has allowed competitors to enter the space. Clinuvel MUST be faster to capitalize completely on the time it has. If PW does not change his management style, then even if both reCell and Mitsubish Tanabe fail the company will never fully realize it's potential.

I hope others will add their own SWOT Analysis to the list so that we can all learn and be better informed. I will add the strengths / opportunities in another post. It is not all negative there is a lot great things too!
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LevelHeaded2000
Posted on: Nov 24 2019, 06:25 PM


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Strengths, Weaknesses, Opportunities, Threats Analysis (SWOT)

Overview of a SWOT Analysis and Why It's Important
I have been involved in several businesses and one of the exercises that we would perform and that which is taught to be performed is the SWOT Analysis. The purpose of the analysis is to slowdown, stop and think. Look at the business from a birds eye view because it is so easy in business to zoom in on details and lose focus of the details.

By listing this out it allows a personal to take a non-emotional view of a business situation. That way objective decisions can be made and the busniess does not get blind sided by it's failure to recognize weaknesses and theats. This same analysis is useful in an investment even a passive one. The S&O reveals the growth of the company. Where it might go if it executes correctly. The W&T indicates the risks of an investment and the business capability to achieve the opportunities identified.

My Challenge to Fellow Board Members & Investors

I think it would be a good exercise if we all perform a SWOT Analysis on Clinuvel as an investment. We can then share our SWOT analysis on the board and compare notes. Augmenting our understanding of the company and it's future potential. I think such an exercise, if people participate, will only increase the information and understanding of this investment potential for everyone.

Here is some information on a SWOT analysis. It is basically just a list of items for each category: https://en.wikipedia.org/wiki/SWOT_analysis and https://www.businessnewsdaily.com/4245-swot-analysis.html

Please "Thank" this post only if you plan to post a SWOT Analysis in the near future (I will post my SWOT later too)
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LevelHeaded2000
Posted on: Nov 22 2019, 09:55 PM


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I don't see a financial model where it is possible to reach 64AUD/44USD on EPP alone. It could be possible with growing EPP income AND future expectations of other indications. But, if we limited to to solely EPP then the PE ratio would need to come down to about an 8 as there would be no longer future expectation of new cash flows. Clinuvel has around 51M shares now, so multiple that by 44USD and we get 2.2 billion USD valuation.

Now, go backwards from there based on what multiple of income you think is reasonable. For just EPP looking at no other indication it would need to be low like a multiple of 8. That would mean income of 280M a year. Considering income is currently around 13M it seems doubtful that EPP could grow by 21x income.

If you are considering EPP + expectations of Vitiligo + other indications, then I think we could get there easily. I would love to see the financial model used by him too.
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LevelHeaded2000
Posted on: Nov 22 2019, 06:59 PM


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I will not lie since the AGM I have done a lot of soul searching and I am more bearish than I have ever been. I hope the management team can deliver and deliver on time. Clinuvel needs some positive news.
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LevelHeaded2000
Posted on: Nov 21 2019, 06:18 AM


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Saw you replied to a different post. Well if there is more dilution, then that is unfortunate.If there really is > 3% dilution, then I guess the overall market response was positive seeing as it did not drop that amount.
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LevelHeaded2000
Posted on: Nov 21 2019, 05:52 AM


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It is actually the same thing. Who needs photoprotection more than someone who is in a high-UV tanning box that causes skin damage? Every person who tans needs photoprotection. That reduces the amount of skin damage prior to them getting the result they want. That is how you prevent skin cancer.


So yes, indoor tanning industry is a proxy for minimum demand because the people that participate in indoor tanning 1) need photoprotection desperately for medical reasons 2) desire or do not mind the side effect of the drug (tanning) 3) have disposable income.
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LevelHeaded2000
Posted on: Nov 21 2019, 04:32 AM


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Indoor tanning industry revenue is around 3 billion per year in the United States alone. So, I would say at least 1.5 billion in revenue is the floor of what can be expected if the product was easy to buy.
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LevelHeaded2000
Posted on: Nov 21 2019, 03:05 AM


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Dilution is the performance rights package (3%). Only what was voted on will be the dilution. There won't be any surprise dilution (otherwise there is no reason to vote!). If someone heard a higher number during a hard hear to speech it was probably commenting on all the dilution up until this date that was related to performance rights.
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LevelHeaded2000
Posted on: Nov 21 2019, 01:53 AM


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Actually, considering the ASX 200 is down 1.35% today and considering Clinuvel traded down less than it was diluted (3%) I would say the market reacted well to the AGM and it will probably react even better over the next days as it digests the information.
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LevelHeaded2000
Posted on: Nov 21 2019, 12:36 AM


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I bought some over the last few days, but I will be accelerating my buys now. The price is way too low and the potential way too high. The price is too low even just for EPP.
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LevelHeaded2000
Posted on: Nov 20 2019, 08:44 PM


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FYI, remember today the company diluted shareholders by 3% (PW compensation package). So, it is expected the price goes down by about 3% to compensate. Considering how contentious the vote was especially.

Given that, the market responded relatively neutral to the AGM. They docked the company 3% in price for the 3% dilution. In other words, it traded flat in market cap turns.

Overall, I think there was good things in the AGM. The management appears to be thinking bigger, which is important. I think good things are coming.
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LevelHeaded2000
Posted on: Nov 20 2019, 06:48 PM


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In all liklihood it is mostly just shorters and few real sellers. I personally thought the AGM talked about heading in a good direction. I was not disappointed. We can see shorters are generating a lot of sale activity. This is creating a sellers market due to the artificial amount of sellers creating by selling.

I hoped that they would mention Nasdaq listing and I think it can still be in the cards. After all it only takes 4 weeks. One reason for that is that I think it will disrupt the shorters as it brings in new investors. According to the AGM we saw there are only 4300 investors. That is tiny and shows how few investors know about this stock. Having 1000 more investors become aware of the potential of Clinuvel would rocket the stock to new highs and break the shorters.

It is interesting to me that short position did not change much when the stock was 45AUD. That was obviously the time to short, but net shorts did not change much and even went down the few days after. Now that the stock has been around 30AUD suddenly the shorting has increased again. Bizarre to short at such low prices with the promise of new revenue coming and Europe still growing at 20% YoY.

I could completely understand shorting if the company had net losses and was running out of cash and a huge dilution was imminent (like what happened with Avita recently). However, given Clinuvel's financial stability it just does not make much sense. The shorters are literally bringing down the market themselves and they will bring up the market themselves when they rebuy. Not much profit opportunity with that.
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LevelHeaded2000
Posted on: Nov 20 2019, 06:47 PM


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... duplicate ...
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LevelHeaded2000
Posted on: Nov 20 2019, 01:09 PM


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Just eyeballing the map it looks like 80%+ of the US population is within 100 miles of a center. Seems like a pretty reasonable way to start distribution. But is that really the locations? I did not know it could be sold in Canada if so. I haven't had time to review the AGM stuff yet.

One thing to remember about the US is almost every one has a car. So unlike Europe the center does not need to be within 10 miles of someone.
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LevelHeaded2000
Posted on: Nov 19 2019, 08:25 PM


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Regarding the AGM I am feeling confident PW will communicate more of his action steps than he has at previous AGMs. I am hoping that Nasdaq is mentioned and I think it will be. The reasons are:
  1. The company already previous expressed interest in Nasdaq listing. The performance rights indicates the company is moving in that direction. All things point to a Nasdaq listing
  2. I want to see this at the AGM because Nasdaq listing only takes 4 weeks. It would be a good item for management to do to demonstrate that they are operating and executing efficiently. It produces a visible result that the demoralized shareholders can visibly see.
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LevelHeaded2000
Posted on: Nov 19 2019, 08:23 PM


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The "short bubble" marches on. Shorts are now at all time highs in terms of number of shares shorted. Once roll out begins then all these shorters are going to be looking dumb. Many of them accumulated at quite low prices too! When they are forced to cover, then it will provide a lot of price support.
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LevelHeaded2000
Posted on: Nov 19 2019, 01:40 AM


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I would say PW is under a lot more pressure to communicate the plans over the next year considering the controversy over his pay package. As a result, I expect him to be somewhat in a position of defending his vision and thus will likely communicate the action steps more clearly.
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LevelHeaded2000
Posted on: Nov 18 2019, 10:20 PM


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What are people's AGM expectations? I personally want to hear about Nasdaq listing as it can occur within 4 weeks and Vitiligo.
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LevelHeaded2000
Posted on: Nov 18 2019, 04:57 AM


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The AGM is just a few short days away and I suspect we will gain a bit more clarity on strategy. Certainly, we know for sure Vitiligo is on the agenda in the near-term.
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LevelHeaded2000
Posted on: Nov 18 2019, 01:15 AM


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Sounds like a shorter paid for an article to be written. They must be pretty damn scared of losing all their money again.


It is kind of interesting to me that every time the stock price goes up there is suddenly some negative analysis that gets released and eventually makes it way to this board. Seems very intentional to me and indicates the shorters are pretty nervous.
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LevelHeaded2000
Posted on: Nov 18 2019, 01:14 AM


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Yes, you are guaranteed market exclusivity based on approval date. It is around 8 years and I believe it's possible to extend it a few more years under certain circumstances.This also ignores Clinuvel's other patents some of which have been granted in the last year.
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LevelHeaded2000
Posted on: Nov 15 2019, 06:11 PM


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You would want to call the expert EPP doctors if you want to call someone that deals with EPP patients. In North Carolina there are 3 such specialized doctors. If you wanted their contact information you would have to call the APF: 866-273-3635.

Since these are the doctors that would be dealing with EPP patients on a regular basis they would be the ones know, prescribe, and inform their patients (the few patients that probably don't already know about the drug).
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LevelHeaded2000
Posted on: Nov 15 2019, 12:26 AM


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I think distribution will be ramped up faster than realized. Certainly much, much faster than europe. Clinuvel conducted CUV039 in the US in the following states: Alabama, California, Michigan, New York, North Carolina, Texas and Utah. So, you can guarantee that will be 7 of the 8 locations. The trial conducted in those states had 93 patients. The CUV30 trial also conducted in the US had 77 patients.

So, immediately we have 170 patients that already are close enough to those centers to travel, already demonstrated excitement, need, etc, to go to the treatment centers and there are already staff that are familiar with administering the drug, etc. They literally just need the medicine shipped to them and they are ready.


From that patient population alone at let's just say $85k USD per year 14.4M USD in new revenue or double the last 12 months profit of Clinuvel. Since most would be profit it would basically half the current PE ratio of Clinuvel. I think it is safe to say that we can expect at least these 170 patients to be using the drug within a year.
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LevelHeaded2000
Posted on: Nov 13 2019, 08:07 AM


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I guess I did barely miss market close by a few minutes. Hard to keep track since I am on a different time zone and the US just changed their time by an hour. Unfortunate! Hopefully I can buy some shares tomorrow before they go up.
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LevelHeaded2000
Posted on: Nov 13 2019, 07:47 AM


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The sell side disappeared as no one is offering shares for sale. I attempted to buy shares at these lows prices, but when I logged in the lowest ask price was $25.00 USD. I watched it and even that disappeared. Right now the current buy bid is $20.11 USD and the current sell ask is $29.22 USD. So, theoretically if it was possible to do a market buy of 1 share right now the price would jump up to $29.22 USD.

It is almost like most of the ask side was one person and they removed their asks and did market sells and thus crashing the price. At the same time that removed all the asks and now there are almost no asks on the sell side.

I thought maybe it was a data error at Fidelity, but multiple brokers show the same. Very bizarre that the sell side has completely disappeared. AGM is just one week away. Nasdaq listing announcement come on!
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LevelHeaded2000
Posted on: Nov 13 2019, 02:19 AM


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I suspect future cosmecueticals would be offered to asia first. That is the largest market of such products. Considering formulation was done in singapore for drugs and Clinuvel is working on additional products it might make sense to remain in Singapore. As far as US rollout I do not think PW has much "on the ground" work to do in the US. The EPP centers in the US have likely been awaiting the treatment for a number of years and have been in contact with the company over the years (many of their patients would have been in trials run by Clinuvel over the years and some of them have been receiving the drug from Europe already).

My guess is that US rollout once formally initiated will happen faster than people first suspect due to this factor. Anytime PW needs to specifically be in the US it is a cheap plane ride away. I have made the trip many times between Singapore / Los Angeles.
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LevelHeaded2000
Posted on: Nov 12 2019, 08:21 PM


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I still hold the stock because the company has a bright future. Nasdaq listing does not affect where it is headquartered or books revenues. It is exciting because it is very achievable and it will improve liquidity and broaden the investor base.

QUOTE
Again in the waiting game?


Investing is a waiting game regardless of what asset you hold and Clinuvel is not unique in that. There is no difference in waiting with Clinuvel or waiting in another asset. It just so happens that near-term (2 years) Clinuvel has very good prospects, so it makes sense to be holding it. Hindsight is always 20-20. Obviously everyone wishes they sold at 45 AUD and bought back again at 30 AUD. Trading, on average, is a suckers game though (look at Iggy!). When the stock price is 60 AUD then people will be glad they did not sell at 45 AUD. That is how it works.


QUOTE
Fda puts no hurdle, but Cuv Limits the market itself

You say yourself that 1) FDA puts no hurdle 2) Management spoken words cannot be taken literally 3) Management says they will limit distribution to EPP patients. Given this combination of facts I would say there is a good chance that #3 is not actually true in reality. The pressure / incentives to broaden distribution will likely mean it is done. Give it time and watch it unfold. Be thankful you still hold 3000 shares, so when it is 60 AUD you won't be totally regretful.
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LevelHeaded2000
Posted on: Nov 12 2019, 05:48 PM


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According to this document https://listingcenter.nasdaq.com/assets/initialguide.pdf it takes 4 to 6 weeks to process a Nasdaq listing:
QUOTE
it generally takes four to six weeks to process a listing application, this time frame is variable and may be shortened considerably, if the application raises no issues and the company responds quickly to Staff comments


It is pretty obvious that a Nasdaq listing is first-priority for Clinuvel. This is covered by PC1 in the performance compensation package and the intention is made evident in the conditions of the conditions:
QUOTE
in case of a recession in the country of the Company’s primary market exchange...outperforms either the Nasdaq Biotech Index or ASX Healthcare Index...

Obviously the "primary market exchange" is currently Australia. The only reason for that language is if it was expected to moved to another market such as the USA (Nasdaq). Considering the short timeline for Nasdaq listing I think it is very conceivable that Nasdaq listing will occur early next year (Q1). I would hate to be a shorter during that time period! Hopefully Clinuvel offers some insight on this during the AGM.
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LevelHeaded2000
Posted on: Nov 12 2019, 03:36 PM


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I am hoping for some news about a Nasdaq listing at the AGM. Clinuvel should qualify to be listed and once the process is initiated it only takes a couple months. After management gets their performance package, then I don't think they will care about opening up voting rights going forward that Nasdaq will bring. So, I think it is a strong possibility.


Regarding the shorting, it appears shorters stopped for a bit and price rose. My guess is they shorted a lot more as soon as it rose to bring the price down. The short percent is not nearing highs again. Good news is we already know what happens as soon as they stop actively shorting: price rises. It seems unlikely they will keep shorting much more.
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LevelHeaded2000
Posted on: Nov 12 2019, 07:10 AM


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For sure, it is worth watching as I stated, but right now there is a long chain of IFs that require it to affect our investment in a non-speculative way. It needs to prove safety over a period, effectiveness, and commercially viable. The company developing could shelf it and we don't hear about it for the next 10 years. Especially considering it is a pill it could cause elevated liver risks, which is especially risky in EPP where patients have toxicity of the liver. It could prove not very effective or to have a worse safety profile. Even if it is effective it may not be approved because regulatory agencies tend not to approve drugs that are equally as effective, but less safe as existing treatments. That would only put patients at unnecessary risk.


My point is simply everything is evolving. This drug is on step A. It might make it to the finish line of step Z, but a lot of drugs disappear on their way to step Z. If later trials of this drug prove less safe or have some other undesireable characteristics, then I imagine they will try to buy Clinuvel. Keep an eye on it, but don't lose sleep yet is my opinion. Until then, let's hope we get some good news at the AGM.
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LevelHeaded2000
Posted on: Nov 12 2019, 04:12 AM


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I hold my shares at Fidelity and thus far there has been no voting info:
QUOTE
There are no open proxy campaigns available at this time. You can expect to be notified prior to a company meeting.

If I get one though I will vote No even though I don't think it is the end of the world if it passes I still think the terms should be modified slightly.

Regardless, I look forward to all the activity at the AGM. Is anyone here attending so they can report back?
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LevelHeaded2000
Posted on: Nov 12 2019, 04:04 AM


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What would be interesting is if Mitsubishi Tanabe tried to buy out Clinuvel eventually. It is demonstrated they are already interested in the space.
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LevelHeaded2000
Posted on: Nov 12 2019, 03:58 AM


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Is it a threat? Sure, but there are a lot of IFs. If it proves safe, effective, something regulators will pass, and something Mitsubishi Tanabe wants to continue investing in, etc. If any of those IFs fail, then it disappears into the vapor like so many pharmacy ventures do. Even pretending all the IFs come to pass it will still be many years away. For now, I don't think it is a huge worry.
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LevelHeaded2000
Posted on: Nov 11 2019, 11:54 PM


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I for one am excited as hell to be part of this company that is really just embarking on it's commercialization plan. A biotech with no debt, profits, growing revenues, and minimal share dilution is a gem. People can complain all they want but the truth is that compared to peers Clinuvel is a tight ship, well run financially, and has treated shareholders well.


2020 is the year of Clinuvel!
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LevelHeaded2000
Posted on: Nov 9 2019, 05:10 PM


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Agreed. When I read the documents it made me realize that we need PW more than ever. I want a CEO that will manage the expectations of the stakeholders while moving the company forward. Running a company is dirty business. Anyone who has ran one knows it. There are a lot of expectations to manage from employees to shareholders to regulatory bodies, etc.

Did he bend the truth, lie, etc? Sure. He also got us over the finish line. Many people on this board would have lost faith and sold if he told the truth and it would have been to those people's loss. He lied and managed expectations due to a timing issue.


At the end of the day he did exactly what he said he would and that is get FDA approval. If he stretched timelines and fibbed about the exact point in the process and did not deliver it would have been a big issue. But, he did deliver despite the hurdles. Despite the issues with the trials and objections he got FDA approval and he got it unanimously from the committee. For that I say thank you PW and Clinuvel employees!

Anyone else ready to move on from the Evil Management Conspiracy Theories the board has been going on about for weeks and start looking at the bright future?
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LevelHeaded2000
Posted on: Nov 9 2019, 03:47 AM


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One issue of contention was the canula used to deliver the implant. The device used in Europe is not available in the US. So Clinuvel had to find an alternative in the US and prove it worked without altering safety / efficacy. In addition, Clinuvel had to submit a supply management plan in case the device was discontinued (and thus would mean drug delivery would be impacted). As part of this supply management probably includes some type of inventorying to give them time to seek an alternative device. In the response they said:

QUOTE
The American Porphryia Foundation has stated that not more than 400 patients would be expected to seek treatment with Scenesse across the 8 US states.


This indicates to me that initial rollout is focused in 8 US state (they were not listed as it was redacted). I am not sure whether the "400" is the estimated number of EPP patients in those states or whether it is a subset of EPP patients (those that could potentially seek treatment). However, if even 300 (75%) of those patients sought treatment at 6 implants a year at $18,500 per treatment would be almost $33 million USD additional revenue. Most of which would be profit. Not bad for 8 US states!

The proposed dosing is every 2 months:
QUOTE
The proposed dosing regimen is one implant administered subcutaneously every 2 months. The overall duration of treatment is at the specialist physician’s discretion.

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LevelHeaded2000
Posted on: Nov 9 2019, 03:08 AM


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I haven't come across anything serious. We already knew there were issues in the original trial designs, but that is drudging up issues from 2013 and before. All that has already been well publicized and known for 6 years now. I don't think we need to keep discussing it now 6 years later. The drug has been deemed safe and effective by the reviewers and that is what maters:

QUOTE
The clinical reviewer concluded that the Applicant provided substantial evidence of effectiveness based on the improvement in hours of direct sunlight exposure in Study CUV039.1 .... The afamelanotide implant provides an effective and safe treatment option for patients with EPP without significant hepatic involvement... The available evidence of safety and efficacy supports the approval of Scenesse (afamelanotide) implant, 16 mg to increase(b) (4) pain-free light exposure in adults with a history of phototoxic reactions from EPP. In view of a favorable overall benefit/risk assessment, the review team recommends approval of this product.


Certainly the management has made mistakes, but my guess is they (hopefully) have learned from most of them and will be sharper and more strategic going forward. New management would just mean a new set of people that now need to make a bunch of mistakes to learn from and re-do the learning curve all over again. Not even including the time it would take to get new management, the disruption to the business, etc. I am not really following your call for new management. The risk that new management could bring cannot be understated. Far less risky and profitable is to profit from this drug under current leadership, IMO.

As for me, I am just excited about US commercialization and hopefully the beginning of Vitiligo trials in the next year.
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LevelHeaded2000
Posted on: Nov 7 2019, 07:11 PM


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I would disagree the shorts are in a comfortable position. Volatility within biotechs is very large even on no news. The shareprice could easily go back to $45 AUD on very little news. The question is what is the current sentiment? In my view Clinuvel has been in a negative feedback sentiment loop. You see that on this board with the hyperfocusing on negative, but trivial things and the lack of focus on positive, but significant things. This sentiment can change very rapidly and without much cause. That is why low-liquid biotechs have huge trading ranges.

If you look at the stock price of Clinuvel we see the following things:
  1. The mid-point of it's 52 week range is $30.82. It is currently trading below this
  2. I don't have a volume-weighted based indicator, but looking at the chart the average volume-weighted share price during the last 52 weeks is around $32 AUD (eye balling it). This means most all shares traded in the past year are not "in profit" and thus unlikely to sell.

Based on this data I would say that we are near bottoms and that there is likely not going to be a huge volume of shares much lower than this. Keep in mind the shorters need to buy 2.7M shares to close their shorts. That is a lot of volume at a particular price point.

The stock has been hit with a lot of negative recent events that has created poor sentiment:
  1. Performance rights and hyper-focusing on this despite its trivialities
  2. Lots of profit taking post-FDA which is likely mostly done considering it has been a month
  3. A quarter result that did not beat last year. However, we are up 17% for the year and there is strong evidence that seasonality / account booking was the cause of the non-Q3 beat. I fully expect Q4 to beat last year's Q4 which due to the same seasonality / account booking was very small numbers last year for Q4 (because likely the business was pushed into Q3 last year)
  4. Spain not reimbursing
This confluence of factors has contributed to poor sentiment in the short term. However, things in the rear-view mirror always appear smaller as you move away from them. The same will happen with the performance package, which will be forgotten in a month just like it was forgotten in 2014. Q4 will almost guarantee beat Q4 last year which bring a lot of high-fives from investors. And news about US commercialization will make people re-focus from Europe to the US. This is how sentiment changes when investors focus on future growth and possibilities instead of focusing on negatives from the past.

So, my view is likely that LONGS not shorters are in a very comfortable position. The vast majority of the downside has already happened (probability of 30% drop from here versus 30% gain is way in favor of the gain). Sentiment is poor and likely as maximum poor sentiment. From here it can only get better.

If i was a short I would be much more worried than being a long at this point. Just like we have had days with 6% daily losses we can rapidly have 6% daily gains and it won't take many days to get to better prices.
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LevelHeaded2000
Posted on: Nov 7 2019, 04:25 AM


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I agree. Definitely vote NO. You have to follow your conscience. My point is that when remuneration is passed like it is near guaranteed to be, then remember that in the grand scheme of things it is actually inconsequential, so don't be depressed about it. Don't hyper sensationalize it in your mind. Put it in context and keep perspective.
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LevelHeaded2000
Posted on: Nov 7 2019, 02:17 AM


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I respect your contribution to the board. The compensation issue that everyone has issue with represents 1 percent of the company and the entire compensation package that will never be 100% received represents a maximum 3 percent. Focusing on this is being penny wise and dollar foolish. It is literally trivial compared to so many other aspects of the company. In fact, I bet the effects of the "shareholder revolt" has affected the company more than 1 percent.

Has Clinuvel been mismanaged as a biotech? NO. Your post makes it sound like shareholders have been a great victim under this management. Let's bring some realism to the conversation:
  1. Company has no debt
  2. There is millions of dollars in the bank
  3. The company is growing revenues and profits
  4. The company was one of the best performing ASX stocks last year
  5. The company has increased shareholder value hundreds of percent the last 5 years.
I will be very happy if "business as usual" continues! I understand some of the criticisms of management. I have them to! But, we also have to look at the context. This biotech and management has treated shareholders with far, far, far more respect than the average biotech. The pitch forks are out, but I am not sure management deserves all the ire.

Let's pretend for a second the shareholders all band together and we kick out that "greedy" PW and replace the "corrupt" board. Do you think the uncertainty and turmoil will have more or less effect than the 1% of the performance package people have issue with?
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LevelHeaded2000
Posted on: Nov 7 2019, 01:27 AM


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The remuneration package has serious flaws however it will likely be approved. I doubt they would have created the package without buy-in from the very large shareholders they appear to be in contact with.

Retail Shareholders Are Going Insane and Are Distracted

Honestly, from my perspective there has been some pretty outlandish focus on the remuneration package. Vote NO on it and move on. The amount of discussion that has been had on the remuneration package compared to actual important things like US commercialization and the doubling of the Clinuvel market size and future indications is frustrating.

Context: Assuming PW hits every single compensation incentive (he won't it's basically impossible!) the maximum effect of the PW compensation package is ~3 percent. And the specific section this board is most crazy about is only 1 percent. That's right, this board has been going crazy for weeks over 1 to 3 PERCENT. There is more than 3 percent weekly volatility in the stock. A failure to start the Vitiligo trials within the next 1 year will likely have more than a 3% effect. There are so many more important things that will have broader impacts than this performance package.

I get and agree the performance package sucks! However, the context is that 3% dilution is not much. I have given a few examples of recent biotechs that had 50% dilution during approval time. In fact, it is very, very common for biotechs to dilute far more than 3%. I personally feel grateful that 3% dilution is all the dilution.

We have literally been turning a mole hill into a mountain. If the resolution gets passed (it 99% will), then be grateful in the grand scheme of things this performance package was not meaningful and compared to the overall dilution that biotechs incur due to mismanagement this is nothing.


(sorry investek I did not mean to quote you)
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LevelHeaded2000
Posted on: Nov 6 2019, 03:46 PM


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The performance plan is bad for optics right now. But just like the 2014 performance plan that was much worse it will be forgotten about in a month and investors will be looking at the future. PW just better make sure he executes over the next months.


The spain thing is also probably depressing the mood. Investors are forgetting many countries are already reimbursing. Some will and some won't it's not the end of the world the spain announcement just came when news was already sour. If it came 1 year ago we would have already forgotten about it.. We already know US insurance companies are reimbursing because US patients have flown to Europe paid for by their insurance. So, I would not take spain as a signal that reimbursement will be denied in other important areas.


My guess is that PW is also feeling considerable pressure. No one is very popular when share price is declining and they are asking for a big pay package. As a result, if he responds like most humans he likely working in overdrive. That is probably what motivated the Australia filing. And, I am sure it is motivating more pushing for reimbursement and US rollout behind the scenes.
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LevelHeaded2000
Posted on: Nov 6 2019, 03:30 PM


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Wasn't today the last day for management to update the PW performance plan before the voting? My guess is that not responding to shareholders caused some to sell out. Brace yourself for volatility ahead.


PW never demonstrate execution the next few years.
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LevelHeaded2000
Posted on: Nov 4 2019, 11:13 PM


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Improvement in liver function should be reason enough to reimburse the medicine regardless of other things. From wikipedia:
QUOTE
Protoporphyrin accumulates to toxic levels in the liver in 5–20% of EPP patients, leading to liver failure

The primary focus of the disease seems to be light sensitivity, but the effects it has on the liver may be even worse. If scenesse can even save 25% of them from having an eventual liver failure, then the drug pays for itself 10x.
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LevelHeaded2000
Posted on: Nov 2 2019, 11:22 PM


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I think lower revs on the quarter compared to last year spooked some people. Even though the reason for the lower revs was just accounting. Q4 will likely be far, far higher than last year for the same reason. Overall, revs are still 17% higher than last year and by next quarter I expect it to be > 20% higher.

Clinuvel is in a bearish cycle, but the trend can change quickly to bullish. A lot will depend on how fast management moves. Glad to see the recent advance to submit to australia for drug approval. Hopefully Japan follows shortly.
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LevelHeaded2000
Posted on: Oct 31 2019, 07:17 PM


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Incredible. The drug has been in use for something like 15 years with patients under clinical observation. I doubt 99% of drugs can say this when they are being analyzed for reimbursement.

Eventually I think Spain will overturn this. However, this really shows the flaws in the European national healthcare systems. Countries like Spain and the UK are not actually commenting on the drug. They are creating excuses because their national healthcare system does not have the funds, so they ration medicine.

It is truly a sad thing and something people in these countries are little aware that they are receiving no treatment or outdated treatment because their government is rationing treatment. To countries like Spain / UK any new treatment just means potentially new expense for their national healthcare and thus they try to invent reasons to slow acceptance of new treatment.
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LevelHeaded2000
Posted on: Oct 31 2019, 06:41 PM


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I do not think it is plateauing. I would say the current markets are still growing significantly. Look here:
  • 2018 Q1 - Q3: 24.5M
  • 2019 Q1 - Q3: 28.6M
So far this year we have had 17% increase in revenue. However, it gets more interesting when looking at 2018Q4. Revenue was only 2.6M in 2018Q4. So, while 2019Q3 was slightly lower than last year I expect 2019Q4 to be significantly higher than last year. The difference appears to be mostly in volatility in the seasons AND when it was booked as revenue.

I think we are still on target for a 20% revenue growth in 2019. So, that is pretty good considering no new countries came online. I expect as France / UK / US come online we will see significant growth in 2020 especially the later half of 2020.
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LevelHeaded2000
Posted on: Oct 31 2019, 05:56 PM


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We want PW to be fair to shareholders. As a result, we should also be fair to PW. Part of being fair is representing the facts correctly and some posters I think are not actually representing the value of the performance package and are grossly exaggerating it for effect.

QUOTE
yet his existing stake in the company (which was gifted to him) is already worth $100mil


You cannot bring this up as if this is still compensation he is receiving. He received X shares at a certain price in time. THAT was his compensation the dollar value of those shares. From that point on he is an investor just like you and me and any gains he has are due to his investment gains just like you and me receive. He could have instead sold those shares or negotiated to receive the value in cash at that point in time, etc. Instead, he invested in the company. Same as all of us. So, it is unfair to represent that as "compensation". I don't know the exact value of the compensation right now, but maybe 15-20 million was compensation. The rest was investment gains.


In addition, as you pointed at, the total value of the compensation plan is 45M over 3 years or 15M a year. That is the cost of the company today to print up those shares. PW may not receive anything close to it. It is possible he only gets 500k shares when all said and done. At current prices that would mean 15M or 5M a year for the next 3 years. Too many people are calculating those shares as if they are already worth $200 a piece. They are not.


In addition, no one is applying any risk-adjustment. PW likely won't receive the full 1.5 million shares. There is risk to PW in how much he receives. Share based compensation is always much higher than cash-based due to risk adjustment. He also has risk that the company stock price will suddenly fall and his current shares and future shares lose a lot of value. He is making a big investment in this company too not just in money, but in his time. He could sell his shares and be done with the company if he wanted to.

The PC1 recession escape clause is egregious and should be removed. At the same time I do not think we should witch-hunt PW who has been a staunch and loyal ally of this company and shareholders. All said and done, with PC1 recession clause removed, I am very happy to have PW's continued service.
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LevelHeaded2000
Posted on: Oct 31 2019, 04:34 PM


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No, cashflow is only $300k less. 5.6M compared to 5.3M In other words it is basically the same as last quarter this year. Considering no new countries have come online it makes sense that it would fairly the same. I do not think new treatment centers came online.
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LevelHeaded2000
Posted on: Oct 31 2019, 04:31 PM


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Adding France / UK will basically double the number of treatable patients, so I expect revenue to go up a lot with those additions.
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LevelHeaded2000
Posted on: Oct 31 2019, 04:08 AM


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Blijorps letter I found very bizarre too. I think it is a little disingenuous. The primary issue most people have is in the PC1 pathway 2 poison pill (winning on recession clause). I think most people would be satisfied if this was removed or if PC1 was entirely based on some kind of annualized rate of return (7.5B would be a 70% annualized return) regardless of recession.

Instead of alleviating concerns, Blijorps letter re-focuses shareholders on the 7.5B pathway 1 and tries to ignore the pathway 2 issue entirely. I feel like he is being a bit of a magician trying to direct our attention to the left hand while the right hand is doing something else. He must realize that the 7.5B target is a bit of an illusion when there is a poison pill in the target that has 50% odds of triggering.

Blijorp has a lot of money invested in Clinuvel and unlike PW it is real money not shares given to him. He is obviously an intelligent business savvy guy or else he would not have had the life success he has had. It makes me wonder what the internal politicking is like at Clinuvel that would make him advocate for the performance plan. He must see that PC1 pathway 2 is nothing more than a PW handout for all practical purposes due to the poison pill. Has PW told him he will refuse to work without a the giveaway? Does he believe the company cannot survive without PW?

One thing is for sure the letter would not have been motivated unless some big shareholders expressed concerns. I think at this point Blijorp is not certain the measure will pass in the AGM. Truth is, at half the pay Clinuvel could attract some other very top-talent pharma exec. It would hurt the rollout and expansion short-term, but it would give the company new blood. Even at half the performance package the new CEO would be well-aligned with shareholders.


I personally think PW should remove PC1 pathway 2 (recession clause) as good faith.
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LevelHeaded2000
Posted on: Oct 30 2019, 09:14 PM


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Regarding Performance Rights I think we need to move beyond it. For the most part it sucks, but within the context of biotechs it is not bad. A lot of other companies are diluting a lot more (remember the 500 million share dilution that Avita did the past 18 months).

The PC1 performance rights has a poison pill in it. The rest of the performance rights are good. It appears there is some pushback from investors due to PC1 hence the "Renumeration Chair Letter" that was released today. I personally think the poison pill should be removed or made more difficult, but I won't call it the end of the world if it is not. At the end of the day it is worth 450k shares over 3 years. About 3 million dollars a year at current prices.

In my viewpoint Clinuvel is very, very well positioned against a biotech index 1) much better financial position than most biotechs 2) since most biotechs are still pre-approval that means clinuvel by nature of having global revenues should fair much better than a no-revenue, high-debt, pre-approval biotech that fills the index. Because of this it is basically a poison pill as Clinuvel is guaranteed due to the point it is at in it's development to outperform a broadbased biotech index.

According to the report the average biotech return in the past 5 years was 5.5% annualized. To go from 1.5B market to 7.5B market cap in 3 years it would take a 70% annualized return over 3 years.

So, we can see a huge disconnect between these figures. A non-recession meeting of PC1 requires beating the indexes by 65% lead (70%-5.5%). However, suddenly when it is a recession it only requires beating the index by a 9% lead. And it only requires this for ONE quarter! The rest of the quarters it can perform even worse than the index.

To me, that is why this is a poison pill. There is no need to change the internal rate of return between non-recession / recession. The poor performance of the biotech index during a recession compensates for the recession in the first place.

So, obviously, this is a sleight of hand (poison pill) It is designed to get investors looking at the first pathway of PC1 and ignore the possibility of the second pathway. When know that while the second pathway is not guaranteed it is statistically likely.

My Overall Point
  1. Yes, PC1 is basically a way to give PW 450k in 3 years. There is probably a 50% chance it will be triggered as-written (due to recession clause).
  2. No, this 450k share give-away is not the worst thing in the world. It does not change the future projections of the company
  3. The overall dilution of the company is actually low. This specific dilution looks jarring especially given it is given to one person. However, the overall dilution of Cilnuvel is far lower than it's peers and that is something we should be thankful about.
  4. The remuneration will likely be passed whether that is right or wrong. As investors we need to look at the overall context which I think Clinuvel is still far better than average even in this case of remuneration. And I think we should stop focusing on it and move forward looking at the business development the company does (like the new Australia priority review) as that is what is important.
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LevelHeaded2000
Posted on: Oct 30 2019, 07:12 PM


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Posts: 536

I think Australia is likely worth $15 million a year in revenue. It is awesome news, though upcoming UK and France will be considerably larger (3x, easily). It is nice though to keep adding companies to expand the income and revenue. A lot of people forget that Clinuvel still has a LOT of profits to extract from Europe.


Total profits in 2019 were 18 million. My guess is that australia revenue will mostly be profits because it's mostly marginal costs and they already have an office there, etc. So, while Clinuvel's profit % is currently about 58% of revenue the marginal revenue from Australia will likely be 80% profit. After all, things like the cost of the CEO, cost of most staff, etc, don't change just because they are shipping implants to Australia.

So, given that, Australia could add 12 million to the bottom line. That alone, excluding UK / France / USA / etc, would put Clinuvel's profit at 30 million. Clinuvel is trading at 85 P/E ratio. All things being equal once the australia income is added the PE ratio will drop to 50. Remember, that is excluding UK / France / USA and more new countries ALL of which are larger than Australia. Add in those other countries and the PE ratio could drop to < 20 very easily.

It shows you quickly the stocks fundamentals can change. My point being that Clinuvel investors are basically not counting ANY other indications in their evaluation of the company. They are solely only considering EPP.

As investors begin to account for future indications and growth the stock price will surge, IMO.
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LevelHeaded2000
Posted on: Oct 30 2019, 01:47 AM


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How I remember the good old days when Iggy pretended to be a "long" and then suddenly found a cure for every skin condition by taking the drug "Cimetidine" that was going to obsolete Clinuvel's scenesse. He implied the stock would go to $0.00 so we should all sell. Imagine if we had listened to him!

Iggy's method of operation is to pretend to be bullish / long on the company and then slowly bring up "concerns" and "doubts" that he has to convince people to sell. I wonder exactly how many other user names he has posting on the forums right now

Like you said though if Iggy is back posting it means someone is acquiring shares. For Iggy's sake I hope he buys some shares this time around and finally makes a profit.
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LevelHeaded2000
Posted on: Oct 28 2019, 05:29 PM


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What worries me about AVH/RCEL, etc, is that they look to be quite pumped. Biotechs have very broad trading ranges even when there are no changes in material facts of the company. A biotech's stock can double or half simply due to changes in investor optimism. I would call this the "hype cycle".

I personally try to avoid biotechs that are already underway in a hype cycle simply due to the large risk of the optimism imploding and the retail investors fleeing. Avita especially seems to be loved by retail investors. Rising prices generate optimism and excitement which generate more rising prices in a feedback loop. This occurs until an implosion comes and the feedback cycle works against the stock as prices decline with more and more pessimism. It is hard to predict when the trend abruptly changes. In these environments thinly traded stocks become overbought or oversold (like clinuvel is now)


I would rather invest in a biotech that is at the bottom of a hype cycle. That way I benefit both from the expansion of expectations due to increased optimism and due to any material change in the company.

Clinuvel looks like a company that will benefit greatly by changes in optimism. Given that it is trading at the same price as 6 months ago prior to FDA approval and given the very low amount of retail ownership it indicates that the general sentiment is actually fairly pessimistic. The thing about sentiment though is it usually follows a cycle, so my feeling is that Clinuvel will benefit both by sentiment changes and material changes in the company.
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LevelHeaded2000
Posted on: Oct 27 2019, 06:11 PM


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What is interesting to me is many of these companies seem to have a lot of retail investor following. For example, Avita has lower market cap than Clinuve, but look at it's yahoo discussion board. Full of retail investors. Clinuvel discussion on the other hand is the same 2-3 guys with different names that talk to each other for the past 5 years.

We have seen how few shareholders Clinuvel has. It is mostly a few large shareholders. To me, this seems like a big opportunity. Clinuvel is very far away from saturating potential retail demand for it's stocks. As it becomes more visible then I think it will attract more retail investors and that will be a big opportunity for stock price. Right now it is still an unknown company to retail investors, IMO. Imagine the share price potential of Clinuvel when it becomes as "hot" to retail investors as stocks like Avita.

In case people think I am misinterpreting the retail following of Avita versus Clinuvel here is more evidence:
  • https://www.reddit.com/r/stocks/comments/b2qfsv/avita_medical_dedicated_discussion_thread/
  • https://www.reddit.com/r/stocks/comments/d4eym5/avita_medical_dedicated_discussion_thread_vol_2/
That is stock discussions created on reddit with over 800 combined comments. Searching "Clinuvel" to see any related Clinuvel discussion and it is a ghost town -- nothing.
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LevelHeaded2000
Posted on: Oct 27 2019, 04:15 AM


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Posts: 536

The contraceptive drug is not approved in the US. They do not even expect commercialization until 2021 and that assumes it gets approved which it may not. Mayne appears to be a turnaround story. It is yet to see if it will turn around. That is why it stock has been in decline for a year and year-over-year revenues are down and it has impaired some 300M worth of assets.

Regarding whether Mayne or Mithra are more expensive I have a feeling you are equating share price to expense. The market caps are almost equal. So, spending $1000 will buy the same percent of the company regardless of how many shares it gets you. The percent of the company you own is what is important. For example, Avita $0.6 a share. Clinuvel is $32. Is Avita "cheaper" than Clinuvel? Absolutely not. Clinuvel has like 50 million shares. Avita has over a billion shares. Hell, avita created over 500 million shares in the last 18 months. 10x what Clinuvel has.

As far as which is cheaper in terms of ROI for dollar spent I would be wary of Mithra since it is in Brazil. Different regulatory environment. There are additional corporate governance risks in Brazil that do not exist in Australia, IMO. So, for that reason alone I would stay away from it though I don't see a lot compelling about it even without that issue.

Overall, I think Mayne it is not a bad bet. I would probably wait a few months though. In all honesty though I think Clinuvel will produce far more return in the next 2 years, so that is where I will put any additional money.
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LevelHeaded2000
Posted on: Oct 26 2019, 08:26 PM


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Nasdaq listing seems easy and quick. There is almost no reason why it won't be done. The process takes 6 weeks from submission. Here is the detailed listing guide: https://listingcenter.nasdaq.com/assets/initialguide.pdf

Listing fee is $80k to $235,000, so very little compared to the benefit.

Notes About Listing as Relates to Clinuvel
Nasdaq Global Select market are more stringent than Nasdaq Global Market and Nasdaq Capital Market is least stringent. So, in order of exluvisity it is Global Select Market > Global Market > Capital Market. Passing financial / liquidity requirements + board of governance requirements will make listing available.

Financial / liquidity requirements:
  1. Global Select Market - financial / liquidity requirements - Passes
  2. Global Market - financial / liquidity requirements - Passes
  3. Capital Market - financial / liquidity requirements - Passes
Based on this Clinuvel can apply for any of the corresponding markets assuming it can meet the Corporate Governance Requirements.

Governance Requirements:
  1. Distribution of Annual reports - Passes
  2. Independent board - Passes
  3. Audit Committee - Passes - This was established this year it appears. In fact, the established audit committee seems created to exactly fit the Nasdaq listing requirements: https://www.clinuvel.com/wp-content/uploads...ee-CUV-2019.pdf
  4. Compensation of Executives - Passes
  5. Nomination of Directores - Passes
  6. Code of Conduct - Passes
  7. Annual Meeting - Passes
  8. Voting Rights - Unknown but I think passes
The only one that I am not sure about is Voting Rights. I personally think it passes. I do not think the ADR situation affects Nasdaq's view of voting rights. Here is the document with more technical listing of requirements: http://nasdaq.cchwallstreet.com/NASDAQTool...Dequityrules%2F

Searching for "5640" will yield the voting rights section. It appears Nasdaq takes a very flexible view of voting rights. It even has various escape clauses like accepting any voting rights issuance that is legal in a foreign companies home country for non-US companies.

Given ADRs are quite common and may not come with the same voting rights and given ADR issue disappears once Nasdaq listing I cannot imagine that it would be a limiting or unusual factor for Nasdaq. I personally think the ADR voting issue is not something that will raise question with Nasdaq.


My personal: Nasdaq listing is guaranteed and it can happen in as little as 6 weeks!
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LevelHeaded2000
Posted on: Oct 26 2019, 07:43 PM


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I think the performance rights implies a Nasdaq listing. The performance rights are designed to maximize shareholder value. The method that is used to do this is up to management.

So, I would say the "Nasdaq listing" performance rights is the same performance rights that gives shares for a market cap of 7.5B. A nasdaq listing is just one of the expansion activities management will pursue to reach said level.
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LevelHeaded2000
Posted on: Oct 24 2019, 09:07 PM


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I don't think many posters are putting faith in it. It is more likely that they are getting hyped because they see something that corroborates what they intuitively feel right or wrong.

I personally expect the stock to be somewhat range bound with a slight upward trend. I do expect November to higher than now simply because it seems most sellers are done selling and shorters probably don't want to risk doing a lot more shorting, but I don't expect a 50% bull. That will come in probably something like January when Clinuvel fires off a press release about official roll out to the US, first product sold to the US, etc. That, IMO, will mark the real, meaningful trend reversal into a strong bull uptrend.
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LevelHeaded2000
Posted on: Oct 24 2019, 08:50 PM


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Yes, I believe Clinuvel will show similar stock chart as Avita. The PW incentive package incentivizes PW to market the company, so that will be the deciding factors. Clinuvel is mostly held by 20 large shareholders. It needs to get a few more thousand retail holders and new institutions on board. That is when stock price goes up 5x.


Looking at the Avita annual report there are some interesting findings.
  1. Since July 2018 Avita has diluted shareholders to the tune of 564 million stock shares (that is over 10x than all clinuvel shares). At current prices that is worth about 400 million dollars. This does not even include the 111 million shares that are unissued shares due to stock options. Nor does it include the executives performance incentives. For all the negatives this board has against the Clinuvel management be thankful that Clinuvel is not diluting shareholders like this. The compensation package while ultimately dilutive it also is aligned with shareholders and there is no way PW will hit every target.
  2. Avita is still suffering from huge losses. I would have no doubts they will dilute shareholders more

I would say if Avita can achieve price increases of it's stock given the above, then Clinuvel which is in a much better financial position and also a growing market will have an easy time producing similar market gains. Clinuvel is in a stronger position than Avita, IMO.

The primary difference between Avita / Clinuvel is the way each management is trying to market the company. Avita is obviously trying to gain more investors (nasdaq listing, lots of PR, etc). This is probably due to the fact that it is a state of continual dilution so it needs new shareholders. Clinuvel does not have that problem. On the other hand, PW's incentive package will encourage him to market the company to more shareholders, so I have no doubt he will over the next year.
Clinuvel's position is even stronger than Avita's. "It will pay off in the end"
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LevelHeaded2000
Posted on: Oct 23 2019, 07:04 PM


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It appears expansion to new countries in Europe was basically frozen the last months. I would be happy with 20% increase over same quarter last year. I expect it will accelerate in the coming quarters (to 50% increase, potentially even more 4 quarters from now like 100% etc). This quarter will get no boost from the US and it will not have benefitted from much business development in EU as that was stalled during the FDA, so I doubt it will be spectacular, but it will be an increase for sure.


I definitely think they can double the results within the next 12 months. They could double the results just in the EU alone. With the new US market there is an even easier way to double the results over the next year.
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LevelHeaded2000
Posted on: Oct 23 2019, 07:01 PM


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Definitely doubtful they will treat new US patients this year (only a couple months left for the year!) However Q1 next year will likely book some revenue from the US IMO
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LevelHeaded2000
Posted on: Oct 23 2019, 06:41 PM


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That's why they are developing new molecules that will utilize better methods to take it (no implants).
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LevelHeaded2000
Posted on: Oct 22 2019, 07:43 PM


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From an investor perspective this has a positive silver lining. This means the company is operationally inefficient and has low-hanging fruit to solve this to get a big ROI. PW has acknowledged this need for better execution and commercialization. His incentive packages aligns with it too. If they do have a shift towards better commercialization, then we could see revenue growth far faster than previously took place. It is better to have the barrier to revenue growth be operational inefficiency than to have the barrier be market saturation. We are far away from market saturation.


The PE ratio could easily drop from 85 it is today to 25 just on EPP alone. If they commercialize faster. That is positive for us. Let's wait and see how Clinuvel responds now that it has no more excuses (no FDA filing, no brexit, etc)
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LevelHeaded2000
Posted on: Oct 22 2019, 06:58 PM


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This is why it is important for PW to have this performance rights. If he doesn't start agressively pursuing sales, then he will lose a lot of potential money because most of the performance rights are related to sales.

My guess is that given his incentives are aligned that he will direct the organization to far more sales focused. Both in terms of selling the product and in terms of selling the company's potential to investors.

The good news is that the delay in reimbursement seems easily solved (unlike NICE which has not been easy thus far). Adding 130 million new population (UK + FR) filled with EPP patients should eventually provide a lot of revenue growth.
Hopefully it wont' take france long to decide on reimbursement especially since they already have patient feedback.
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LevelHeaded2000
Posted on: Oct 22 2019, 06:50 PM


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France and the UK are likely to be reimbursing Scenesse soon. That right there is 130 million people, so quite significant number of new patients most likely. I think people are missing how much potential remains just in the EU EPP patient population.

And of course the US will be rolled out very soon. I am not quite certain of all the post-approval steps that must be done before first-sale, but I imagine as long as that not too burdensome we could get our first press release "First Implant delievered to US EPP patient" very shortly.

Logically, considering US insurers have already flown people from the US to Europe to receive the implant it indicates there are already EPP patients being treated under a dermatologist in the US, with an insurance company willing to reimburse the drug. They already have experience with the drug via the EPP patient they are monitoring who has taken it in Europe. Thus, it would make sense for these doctors to be the first to call Clinuvel for an implant, so they can save their patient a trip to Europe.

Let's hope Clinuvel is savvy enough to make it a press release.
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LevelHeaded2000
Posted on: Oct 22 2019, 01:34 PM


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Congrats on your short of the stock. If you think you can predict broader economic crashes, then you must be the richest person in the world. Truth is, you cannot. You speculate based on what you hear, but no one has yet found a way to reliably predict crashes. People keep expecting great financial crisis. Will it happen eventually? Maybe. But, in the interim staying out of the market and eroding 8-10% of your money a year is a losers gamble.

Lot's of people were screaming recession in 2015. Never happened. Does that mean they will be wrong again? Nope, but the data shows even if they are right, on-average, recessions don't produce stock losses. So, even if they are right on average they are wrong. Now, if another Great Financial Crisis happens then yeah it would be a good call. The question is does lightning strike twice?

Despite all the fear the economy is not bad. Let's look at some numbers. Stop the speculating and look at actual data:
  • Household debt to income ratios: https://fred.stlouisfed.org/series/TDSP Right from the fed. Look at that, we are at historical lows. Boogey man is not so scary now, right? There is still alot of fuel in the fire.
  • SP500 P/E ratios: https://www.macrotrends.net/2577/sp-500-pe-ratio-price-to-earnings-chart At around 20 it is slightly higher than the average, but it is far from bubble-ish levels
The media has been harping about a recession for 2 years. In fact, they harp about it every year because that is what gives them clicks. The problem is the market historically moves at a relentless 8-10% gain per year. Any sucker who sells expecting a recession ends up losing. Those who predicted the recession? Well, half the time they still lose because stocks go up anyways. It is going to be hard to go against the grain of 8-10% a year.

You seem like you buy into the imminent collapse of the financial system due to QE fears. I have more news for you. Japan has been doing QE for a long time. No collapse yet. You think the CBs are out of bullets? I have more news for you. We can look at Japan as an example. Once they exhaust bond the buying they will buy stocks directly. Japan already owns 6% of the Nikkei index.

Is any of that good? No way. My point is that there is still an easy ability to kick the can down the road. Once the US goes to negative rates, then central banks will start buying up stocks to keep stocks afloat. This can go on for years. Why would a sane person go to cash when cash loses 8-10% a year compared to company stock, historically. All based on some tea leaf reading that a crash is 1) imminent and 2) lead to stock price declines (both need to be true and both do not always happen together).

Once QE is finally exhausted the likely course of option will be helicopter money. That WILL drive inflation. And you know what gets KILLED in inflation? CASH. You talk about the old retirees who did not sell stocks and now they are eating dog food. Great anecdote. I will tell you another anecdote. All the people who live in countries like Argentina or any country with high inflation who DID sell stocks, went to cash, and now they are eating dog food. Their savings went POOF into nothing. Company stocks will outperform inflated currency in the general case.

So, my point is that this is complicated. Nothing is certain and there are no easy solutions. Going to cash, historically, results in almost guaranteed losses, period. That is historical fact. Staying in stocks almost always results in historical gains. Again, historical fact. This time might be different and you might have the crystal ball on timing, but I doubt it. Time in market beats timing the market.

Given this, I would rather bet in a solid winner like Clinuvel that will be winning in 95% of scenerios. That is my 2 cents.
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LevelHeaded2000
Posted on: Oct 22 2019, 03:07 AM


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I think there is a difference between what PW says will happen and what will actually happen in reality 6 months down the road. Especially with the performance rights. People normally follow their incentives and the reality is that FDA does not require any of that stuff and PW will succumb to the path of least resistance that also happens to align with his own performance rights package. The drug will be sold to anyone who has a legal right to ask for it (basically any doctor).

So, while they may make an attempt at doing those things initially the reality will end up being they sell the drug to any dermatology office that asks them. They may require the office to record the patient doses, their indication, etc (basically, "surveillance") and report back to Clinuvel to get continual access to the drug, but that is to the company's benefit as it gives them more data.

In the labeling they show how to administer the drug. I am sure a nurse could do it, but even if it requires a doctor it doesn't seem like a big deal: https://www.accessdata.fda.gov/drugsatfda_d...0797s000lbl.pdf
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LevelHeaded2000
Posted on: Oct 21 2019, 05:05 PM


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The only way PW can get close to $230M (or $110M per year) is if he grows the company 500%. As an investor, if he can achieve that, then I say give him $500M AUD. Hell, give him $5 billion AUD. Keep in mind, any investors will be trading with the knowledge of PW getting paid this, so he will have to grow the company against it's own headwind of his compensation package.

I get your sentiment. I wish we had a CEO that charged $0. Hell, I wish we had a CEO that paid the company money for the privilege of working there. Yes, PW is likely overcompensated. His last performance rights package was definitely bullshit. This performance rights package is much better in alignment of incentives. However, yes, it is too much. It probably should be 1/4 what it is, but the truth of the matter is IF PW makes anywhere close to that 230M it is only because he made us 500% more money, so I really doubt many people will be complaining if it occurs (or should I say WHEN it occurs because the stock will definitely be 500% more in 3 years)
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LevelHeaded2000
Posted on: Oct 21 2019, 02:28 AM


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FDA approval did not just mark the day that EPP patients come into the light. It also marked the day that Clinuvel comes into the light. Let the publicity keep rolling in and gain mindshare among investors.
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LevelHeaded2000
Posted on: Oct 20 2019, 11:41 PM


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What you are saying is not really true. Everything is to the boards discretion. All this clause does is enable the board to allow the exercise of grants that would have been earned or to issue the remaining grants if it deems deserved. Nothing about it is automatic. Everything requires a board decision. Look at the language:
QUOTE
The Board may determine that all or a specified number of a participant's Performance Rights automatically vest where ... If no determination is made or if the Board determines that some or all of a participant's Performance Rights do not vest, those Performance Rights will automatically and immediately lapse, unless the Board determines otherwise.

The keyword being may determine. Not should determine. This is not some back door that can be exploited.


Also, some people feel like the thresholds of PC1 (performance incentive for market capitalization) is too "easy" because it starts at a market cap of 1.7B and tiers to 7.5B. Some may think that the starting threshold of 1.7B is too low. The current market cap is 1.5B for reference. It would take a 9.6% return to even meet the first threshold within the next year. That by itself would be better than most stocks perform.

But, likely, this was negotiated prior to FDA approval. In that case, the baseline market cap was something like 1.2B. The fact that it gained approval in the interim does not have much bearing given that this was likely negotiated prior to approval. Luckily there is the 15 day trading clause so none of the thresholds have been hit due to the approval spike.

For the most part I think the compensation is minimal enough and well-aligns executive incentives with our own. I am happy with it, personally.
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LevelHeaded2000
Posted on: Oct 20 2019, 10:33 PM


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When I read this in the compensation report I had a different view point. It basically means that there is a 1.5 million share reward for successfully selling the company to an acquirer. In other words, getting acquired is a trigger condition of all share rewards.

To me, this indicates that there is interest on behalf of the board to get acquired. Otherwise, if they knew the answer to any acquisition is "no", then there would be no need for that clause. I consider it a good thing because I do not think that Clinuvel getting acquired (for a premium) is a bad thing. If PW can find a buyer for Clinuvel that pays a hefty premium, then I have no problem letting him get his performance rights.
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LevelHeaded2000
Posted on: Oct 19 2019, 02:49 PM


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Why Clinuvel Will Beat the Trend


I remember looking at some studies on biotechs post-approval share price performance. I believe some studies were posted to this forum within the last months. Interesting, it seems in about 70% (if memory serves) the year following approval is generally not good stock performance. There is an important reason why Clinuvel will be in the 30% that are successful the year following approval.

The reason being and something that I don't remember being emphasized in the study is share dilution, debt, and negative earnings. It is not that investors suddenly flee biotechs post-approval. It is that companies do share dilution and continue to have negative earnings and they have too large debt loads. THIS is the cause for the majority of biotechs to perform poorly the year following approval. Commercialization happens too slowly for them to outrun the debt / bad spending which leads to a poor financial position, dilution, etc.

For that reason, I think that Clinuvel will have a much more positive post-approval year than a typical biotech since the financial position of Clinuvel is better. It is because it does not have the debt load, negative earnings, and cavalier management most biotechs have.



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LevelHeaded2000
Posted on: Oct 19 2019, 03:43 AM


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Very true. Predicting the future is impossible either way. That is why I wanted to offer a counter viewpoint to the hysteria. Because it is not predictable one way or another (that is why half of recessions yield stock gains and half do not).


If I remember you are a very old holder from way back in the early 2000s. What percent of your share are you still holding or have you long-exited? I am glad to see someone that stood by their investment for so many years either way.
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LevelHeaded2000
Posted on: Oct 19 2019, 12:48 AM


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I agree. Shorts have declined, so much of the selling has been actual holders selling. My guess is that for some people their original plan was to sell after FDA and now they are following through. Regardless, the price has sunk so low that I would say it is "oversold". It is currently $5 USD less than what it was pre-approval ATH despite the de-risking the FDA approval brought.

That is what makes me believe the price decline is purely mechanical. There are a larger than normal amount of people profit-taking. Once they are done and exhausted the unusual selling, which hopefully will be soon, then stock price will resume it's upward trend. So, later one I think we will have news events that bring in more buyers combined with no longer the abnormal selling from profit takers.

Regardless, for any long-term holder it matters not what happens in the short-term.
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LevelHeaded2000
Posted on: Oct 18 2019, 07:27 PM


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I assume by cash flow strategy you mean invest for dividends. I personally am not a fan of dividend investing:
  1. Dividends are usually less tax-efficient
  2. Dividends remove control from the investor on when to realize cashflow
From a mechanics standpoint there is no difference in cashflow generation between a dividend or non-dividend stock. The only difference is who decides when you realize the cash flow. With a dividend stock the company management forces you to realize cash flow. With a non-dividend stock you decide when the realization of the cashflow is convenient for you (by selling a % of the shares to generate the cash flow).

In general, a stock will appreciate according it's retained cash. So, unless management is taking the cash and literally burning it on fire, then the share price will appreciate as it holds cash all things being equal. It is up to you to then sell off shares for your own cash flow needs. Mathematically it works out all the same. You hold fewer shares than if it was a dividend company, but each share is worth proportionately more. End result, the same. The only difference is as stated tax-efficiency and who controls realization of cash flow.

For these reasons I generally avoid dividend stocks at least I want as few of them as possible. However, I would probably focus on REITs if I wanted a small position in dividend yielding stocks.
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LevelHeaded2000
Posted on: Oct 18 2019, 06:34 PM


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Due to the increased media hysteria of an impending economic collapse and increased amounts of people moving to cash, etc, I wanted to make a post about recessions.

People have a serious recency bias with the Great Financial Crisis which was a once in a generation event. Half of recessions do not even result in share price declines. You can look more on recession data here: https://awealthofcommonsense.com/2015/03/st...ter-recessions/

So, for anyone who going "all cash" waiting out for some global collapse you might want to re-think it. Nothing is more of a defensive stock than a high-growth biotech with no debt, positive income, and revenues secured by gov / large insurance. Trying to time a global crash is a fool's folly. Even if you get the recession right half the time you will lose money as stock prices go up.
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LevelHeaded2000
Posted on: Oct 18 2019, 06:17 PM


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The company has quite a few large shareholders (82% of shares held) and it appears that those shares are fairly locked up in the hands of long-term holders who are not selling anytime soon. So, basically, us retail investors are trading back and forth 18% (8.7M shares) of the company. That is really where all the share churn appears to be.


I think it is apparent that Clinuvel does not have a broad investor base. It's investor base is the result of a few and very committed investors that believe in the company. Other than that the company is quite iliquid which is why a short that introduced 6% additional supply in a short time period was devastating to the stock price.

The positive news from my perspective is the company will hopefully attract more retail interest with additional press releases, commercialization, etc. Considering Clinuvel has so few investors any increase in investor interest will have a huge effect on the share price (just like the small short had a huge negative effect on the share price --- it goes both ways).
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LevelHeaded2000
Posted on: Oct 18 2019, 04:45 PM


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Agreed. I think some of the recent price decline is a result of the emphasis on a controlled distribution strategy solely to EPP patietns. I think this will relax in time. Simply due to practicality, incentives (look at CEO's new compensation incentives), and due to the FDA not having any real power (or even desire as they are not the ones that are trying to restrict access) to stop it.

I have to imagine the seemingly unnecessary language / emphasis of controlled access is simply a byproduct of the culture that developed at Clinuvel over the past 5 years with the EMA, etc. I think it will be relaxed in time going forward in the US at least.

As you said, it is unethical to try and control access. The gatekeepers of access in the US at least are the doctors. Not the pharma companies. So, if Clinuvel stands in the way of the appropriate decision-makers (the doctors), then that would be unethical, IMO. Based on that blog post by the dermatology doctor in Florida he is already moving to provide access to the drug for Vitiligo off-label. I think that once the team has more exposure to the US system, then it will soften their stance which was developed under the culture of the EMA system, which is far different.
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LevelHeaded2000
Posted on: Oct 18 2019, 04:41 PM


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I don't think he was saying the same 80k patients will be treated. It will be a new set of 80k. Prevalence of Vitiligo is 1%, so about 70 million wordwide. Of course some of those are not in the target or able to afford the drug. Regardless, the potential population is millions. I think it is reasonable that 10s of thousands of treatments will occur per year. Vitiligo is a disease that progresses over time. The treatment appears durable, but there is no way it completely stops further progression. So, I think re-treatment every 5-10 years can basically be assumed.

Given this, 10s of thousands of treatments worldwide seems like a no-brainer. Regardless, it will be BIG money.
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LevelHeaded2000
Posted on: Oct 18 2019, 03:16 AM


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It seems common with biotechs. I think it is simply supply and demand where a large supply floods the market in a short time period. As you saw on this forum where many members announced profit-taking. There are millions of shares that were locked up waiting for approval and they suddenly flood the market right when it gets approved. So, it takes a while for those shares to change hands.


Once those shares change hands, then the price starts to strongly drift upward again as the available shares for sale decline rapidly. I have to imagine we are getting close to sellers and buyers being matched for a bit and will get sideways movement and then upwards movement.


In Clinuvel's case I think that no one believes they are going to pursue Vitiligo. Once they start announcing positive action towards Vitiligo, then I think the doubt will be broken. Remember, one year+ ago they announced to start a new clinical trial Q1 2019. Never happened. So, investors doubt. Once bitten twice shy.

So, investors need to see positive action towards Vitiligo. Tto me it is great because I did not think they would pursue vitilgo so soon. I thought they would pursue a smaller orphan like HH or AG. So, if they start pursuing Vitiligo which is a huge market, then things really start changing. I am confident the Vitiligo program will advance because liteterally there is nothing else the company can do. They don't have an excuse, so unless they stare at a wall all day, then they will be advancing Vitiligo. It's not like the company is not capable of doing it. It has ran something like 19 different trails and has gone through several approvals where 2 were successful.
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LevelHeaded2000
Posted on: Oct 17 2019, 07:24 PM


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March 18th the stock rose rapidly to $29 AUD. By April 18th the stock price had collapsed to $21.8AUD. I imagine many holders felt the same. If only they had sold at $29! Well, lucky for those holders they got a chance to sell at $45 AUD just 6 months later and even today the stock price is above $29 AUD. That is the power of holding a stock with long-term good prospects is the long-term trend is up even if short-term is down.

I wonder what price the stock will be in 6 months. My guess is you will be thankful you never sold because it will probably be around $55AUD
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LevelHeaded2000
Posted on: Oct 17 2019, 07:20 PM


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And just because it takes Vitiligo 2 years before it hits market does not mean we will not get benefit of it prior that. As Clinuvel makes more announcements about it's FDA meeting, does trials, etc, investors will begin to be more optimistic and will start speculating more on the stock and it's future direction.


We could start seeing the trending upwards of the stock price due to Vitiligo expectations within months.
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LevelHeaded2000
Posted on: Oct 17 2019, 07:16 PM


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There are lots of moats. Here is a list of them
  1. Patent on the existing molecule
  2. Market exclusivity for approved indications
  3. Patents on new molecules (like the one recently issused)
Keep in mine that even when #1 runs out that does not mean there will be competition. The FDA grants exclusivity, regardless of patents, for 9 years or so. So, that is an absolute moat for 9 years. I believe there are some ways it can possibly be extended. There are also things that make it likely to have a monopoly on the market even when exclusivity run out. For example, the fact that it is an implant, harder to manufacturer, uses specialized treatment centers, etc. Sure, when the patents runs out someone can take the drug and shoot themselves up with an injection. That has been available for years for anyone that wanted to. The problem is the peptide has a very short half life, so most people don't want to have to shootup every 4 hours of their life. That is why Clinuvel developed a time-release implant.

Clinuvel has fresh patents on other molecules for topical delivery, etc, that will also eventually obsolete the Scenesse in time. They should be ready well before any market exclusivity runs out.
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LevelHeaded2000
Posted on: Oct 16 2019, 03:47 AM


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I believe it was actually a phase 3 and a trial that is a few years old. I looked into before, but I didn't bookmark it unfortunately. It was a second phase 3 in europe I believe.
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LevelHeaded2000
Posted on: Oct 16 2019, 03:06 AM


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Btw, this gives a pretty good list of various skin therapies related to scenesse: https://www.skintherapyletter.com/dermatology/afamelanotide/

I could see acne being the target of a potential OTC. It may not require too much active ingredient to penetrate the skin into the blood and as a result would be a good candidate for an OTC (which has more rules than an rx about what is allowed). No idea if it would still be effective for acne based on that, but it seems like a good chance considering acne happens at the pore level and the mechanism of action is inflammation reduction.


Lastly, I think there is a HUGE business in rx-based topical cremes. Even if an OTC topical that causes a tan is not released in the next couple years there is a LOT of skin diseases that would benefit from an rx-based anti-inflammatory based on scenesse.

It is not like getting an rx is hard. Hell, insurance even pays for the drug as an rx. So, ignoring the OTC, just getting a topical will be HUGE news period even if it requires an rx.
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LevelHeaded2000
Posted on: Oct 16 2019, 02:56 AM


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Agreed. I view the OTC as a completely separate business. Likely Clinuvel is just leveraging it's brand and the fact that it is an FDA / EMA approved dermatology company to lend credibility to it's OTC lineup and increase brand positioning in consumers minds. I do not think the 1st generation of OTC products will be related to their rx products in any way.

It will probably be products like this: https://www.dnaegfrenewal.com/collections/a...eneration-serum also high end sunscreens will of course fit. The sunscreens found in most stores are surprisingly crappy with some pretty bad chemicals in them too.

Skin damage prevention (or "sun burn prevention") will likely be pursued after Vitiligo. No reason why it wouldn't be. It doesn't need a lotion. It can use the implant. I personally would prefer the implant than a daily lotion (I hate things on my skin). High risk populations like skin type 1 would benefit from it and if it was reasonably cost an insurance company may pay for it because cancers are expensive. Though, it could be an rx product that people pay for out of pocket (look at botox. That is rx, administered by a medical facility, and people generally pay for it out of pocket).

I think Clinuvel will of course have a topical that creates a tan, but it won't be OTC within the next few years. There are various rules on OTC products in the US. About whether drugs can penetrate the skin and how much is allowed, what active ingredients, etc.
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LevelHeaded2000
Posted on: Oct 16 2019, 12:17 AM


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The lack of parallelism is a valid complaint and one I have had for years. However, in the investor relations conference call PW explained the reasons for this and to me it alleviated some of my concern. You have to understand the context the company operated in has changed and thus it's execution style will change too.

The reason for not pursuing Vitiligo / AG, etc, further was because they would be presented to the exact same committee at the FDA as EPP (dermatology committee). So, if they could not get the committee to understand and accept the drug for EPP then there would be no hope for the other indications and thus the capital would have been lost. Keep in mind, the company had 3 separate failings with the FDA in it's history, so that was the perspective it was coming from.

PW is very financially conservative. That can be great as Clinuvel didn't become indebted and have 50% dilution like let's say Palatin. However, the downside is decisions like this. He decided to forgo advancing Vitiligo, etc, until he was certain there was a regulatory pathway. If EPP was not approved, then all the investment in the other indications would have been lost capital. So, he took the conservative approach with capital to ensure the company's ongoing survival even with EPP denial.

Now, the context has changed. I do not think we can judge PW's decisions in one context and assume it will be the same in a different context. I expect that the aggressiveness in pursuing other avenues will be much different now that the context has changed now that a regulatory pathway is open at the FDA.
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LevelHeaded2000
Posted on: Oct 15 2019, 08:23 PM


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I understand you already sold the majority of your shares, so you have a particular perspective others on the board may not based on your personal interests and beliefs. I am not sure why you are painting such a dire situation (5-10 years, seriously?) though I can guess it is due to some fear your decision to sell may not have been correct.

I am not here to persuade with vague statement. I am here to present facts and others can decide whether Clinuvel fits their investment objective:

Financial Facts of Clinuvel
  • 12 months trailing profits June 2018: 12.9M
  • 12 months trailing profits June 2019: 18.1M
  • % increase in profits YoY: 40% increase in profits.
Current market cap is 1.685B. That means Clinuvel has a P/E ratio of approximately 93. This is trailing P/E which includes quarters of less income than we expect just considering the EU market. So, what about forward P/E? Let's only count Europe and assume there is $0 contribution from the US. Let's also assume instead of 40% growth we saw last year we only see 30% the next 12 months. So, I am making this as disfavorable as possible for Clinuvel.

That wuold be 23.5M profits next 12 months. That gives us a P/E ratio of 71.6. So, the forward P/E of Clinuvel today NOT counting US income growth and calculating SLOWER growth than we saw in the past 12 months yields a forward P/E of 71.6.

Biotechs are high growth. Clinuvel at this stage should have a high PE. In fact, it should be higher. Most biotechs at this stage have a infinite p/e (negative earnings).
My personal opinion is you are crazy if you think Clinuvel is risky or not doing well from a financial perspective.

How do investors make money from their investments?


Excluding dividends, etc, investors only make money if they sell their shares to someone else at a higher price. So, we must ask ourselves what are the events and context that cause share prices to rise? There are two primary drivers of this:
  1. Increase of net-profits, such as the 40% we saw last year and the likely (IMO) 40% we will see this year
  2. Expectations of future increases in profits. This is what causes the P/E to rise or fall. That's why Netflix has a P/E of 100 and Apple has one of 20. If tomorrow investors become more optimistic about Apple's future growth, then maybe it will grow to 25. That means a higher share price for the same income.
So, we must look at Clinuvel. What will the future deliver for Clinuvel in the relation of these two times? Here is my view:
  1. Profits will continue to grow. A forward P/E of 71 is amazing and this is excluding the USA. With the USA the P/E will shrink to 25 all things being equal. I expect the upcoming, nearly certain profit growth to continue and make the company look even better.
  2. Speculative profit growth is what investors are attributing to new indications, etc. IMO, Clinuvel is receiving very little speculative profits growth attribution by investors. That is why Clinuvel's PE is so low. Going forward, as more news items about Vitiligo come out, I expect speculative growth attribution to increase. This means that Clinuvel's P/E will expand even if it's profits stays the same.

Further Commentary

People who are saying Clinuvel is "overbought" or in a bad financial shape have either no understanding of biopharma or they have an agenda or they are not really financially literate. Clinuvel's financial position is doing very well. It is not in some crazy "investor bubble" as it is not trading at some crazy sky high valuation based on it's category, growth potential, and current incomes. The future is bright in Clinuvel. AND, the present is bright with Clinuvel. Don't forget that.
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LevelHeaded2000
Posted on: Oct 15 2019, 05:12 PM


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I know you are frustrated, but calm down and seek inner peace. If you are invested in this stock for the next year+, then there is no worries. I know in your case you are an older gentleman and want to pass the share winnings to your kids. You own quite a bit of shares. You can just pass the shares themselves to your kids instead of selling. That may give you some peace of mind.

Clinuvel is a solid company. Shorters have ZERO impact on the operations of a company. The only ones shorters impact are people who wanted to sell in the short-term as they will get lower prices. No big deal. Anyone holding long is not impacted other than the self-inflicted anxiety they create for themselves.

Here are some facts:
  1. Clinuvel is operationally efficient, zero debt, low overhead, etc
  2. Clinuvel had a horrible European rollout. This was mostly caused by poor efficacy of their phase 3 trial. This problem has gone away with the new phase IV trial that shows 6 hours benefit versus 0.75 placebo. So, expect European rollout to accelerate, which means the already hefty revenue in Europe will likely double in the next 18 months.
  3. The issues that affected the European rollout won't affect the US rollout. A) US already has updated efficacy information B) Many US insurers are already familiar and are already reimbursing the drug C) The company has experience with rollouts, developing treatment centers, etc D) Much fewer patients need to be educated. The patients already heard about the drug the last 5 years. They are already asking their doctor.
  4. Clinuvel will likely be doing more promotion as a company to broaden it's investor base.

Many people on this board have anxiety because they see a long-road ahead that they are basing on the european rollout. I do not expect a repeat of the EU rollout for the reasons mentioned. In the next year the company will be growing it's revenues and income substantially. We will have more information on Vitiligo which should expand the future revenue growth investors calculate in their models and thus the PE expands.

Why is share price decreasing after the HUGE runup?
It's easy. A lot of people are fatigued holders. They are miscalculating how quickly the company can ramp-up and thus they took profits. You saw many people on this forum itself announce to profit-taking. That's okay. That is the life-cycle of an investor. However, they sell those shares to new, energetic investors that have higher cost-basis and full patience. The runup / FDA approval was an event for many people that triggered them to finally sell.

Once their selling is exhausted, then we will have new long-term holders that are prepared for the next 5 years. The unusual supply of shares in a short time period the FDA event caused will dry up and shares will be scarce again. Price will go up at that point.

Don't worry about these day-to-day stock price movements. Worry about where the price will be in 1 year, 2 year, 5 year from now. And, I can unequivocally say the price will be much higher at these points in time.
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LevelHeaded2000
Posted on: Oct 14 2019, 03:18 PM


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I think the SP is doing good. It looks like most of the slide is likely behind us. It is expected after a huge runup to have some downdrift. Existing long-time holders take some profits to give room for new energetic holders. That is the nature of the market. Give it some time to consolidate around this range.

I expect it to be over $40s AUD in a month or so.
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LevelHeaded2000
Posted on: Oct 14 2019, 04:37 AM


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I mean, they aren't being too secret really. They have laid out their primary plans pretty transparently and to me it looks good:
  1. Establish and penetrate the USA business for EPP
  2. Expand EU business. They have only a very partial rollout in the EU, so there is still a lot of revenue growth potential just from the EU
  3. Get approval / expand in australia / japan (maybe through licensing as hinted in CEO comp package).
  4. Get Vitiligo approved which is the furthest indication in their pipeline. Seeking meeting with FDA to finalize the clinical trial protocols, endpoints, and ethics to bring Vitiligo to market. Vitiligo already having a phase 2 and it is a HUGE market. And, as pointed out in the IR, the same team reviewing Vitiligo will be the same team that reviewed the EPP at the FDA and they unanimously approved it. And, this time around, no manufacturing issues because that has been taken care of.
  5. Pursue other indications further down in the pipeline. Likely will be something like AP, but I guess we will learn more at AGM. In all honesty Vitiligo is the large markets so the others are just add-ons in comparison.
  6. Move to clinic the other molecules that have fresh patents and don't require an implant.
  7. Move forward on OTC products
To me it seems logical that they are wanting to be branded as an advanced, high-end dermatology company. Ultimately their goal is to use their reputation on these rare skin diseases to lend credibility to their OTC products and give better brand positioning of said products in consumer minds. Eventually, the idea would be to blur the lines between the OTC and rx product lines (over the counter tanning / skin cancer prevention)

Given that Singapore seems to be pretty important to them my guess is that the OTC line will targeted towards asia first. Who, btw, spend an enormous amount of money on things like cosmetics and many asians are more brand-conscious than westerners as that is a consequence of a less-regulated market (contaminated baby food, remember that?). Any skincare brands that are OTC to these countries will be greatly propelled by the fact that Clinuvel is an international, FDA / EMA approved dermatology specialist. Asians are much larger consumers of luxury brands.


I think people are missing the potential of the OTC line leveraging Clinuvel's upcoming dermatology brand. It is relatively low-risk, low-startup, fast to market, easy to add-ons and can scale to billions of revenue if it is a hit. It is all about brand positioning in consumers minds. Most companies offering OTC skin offerings are not even real pharmaceutical companies.


Did people already forget why Willem Blijodorp is part of the board and a huge investor:
QUOTE
Blijodorp known for wholesale and international trading of luxury and fast moving consumer goods and pharmaceutical products


I think people are thinking too narrowly about the type of company Clinuvel is wanting to become. The rx products will make Clinuvel billions. The OTC will make them even more billions.
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LevelHeaded2000
Posted on: Oct 14 2019, 02:16 AM


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The price is lower than it was on June 19th before approval. And, shares shorted was just 0.6% at that time. Currently, with a lower share price and FDA approval the shorts are close to 5.5-6% of the company (approaching 3 million shares). Obviously the price is not higher due to continued shorting.


Bringing the shareprice down from June 19th took shorting 5%+ of the company. The last few months has been dominated by ever-increasing shorts that resulted in artificial sell pressure to the tune of 3 million shares. To put that into context based on the activity on this forum and the reported share counts it would be as-if everyone on the forum sold their shares (or even more than that). That is how much that short represents. And, when the short is closed it will be like everyone on the forum doubling their shares in impact.

It is possible the shorts remain open however more likely over the next couple months they will close creating additional buy-pressure. What is extremely unlikely is that shorts outstanding increase from 6% -> 12%. So, we can say for sure that sell pressure going forward will be much less than it has been the last few months. And, buy pressure is likely to increase from more exposure + shorts closing.

This context and given the upcoming news flow is a good indication the share price will rise over the next 3 months.
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LevelHeaded2000
Posted on: Oct 14 2019, 12:24 AM


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Honestly, I feel opposite of you. If I sold my shares I would never be able to sleep. Not only would I be holding something with guaranteed losses (cash), but even if I tried to invest it elsewhere all the other options are worse than Clinuvel. Clinuvel has just been de-risked. Yes, that is partially reflected in the higher stock price that it has now versus 1 week ago. However, I do not think for a second that returning to the same price Clinuvel was a few months ago means it's potential is being fully priced in right now considering it's potential.

Truth is, Clinuvel is a very safe bet on any time horizon that is 2+ years out. Consistent revenue growth will be coming. New indications will be coming. No debt. Good management that is not too dilutive. Source of revenue that is government / large insurance companies. Standard pricing in Europe / USA (so no unexpected getting whacked by some price normalization legislation between US / Europe), monopoly on a product with a captive customer base, so it can raise price with any future inflation, etc.

I think it is great you took some profits. I am even more happy for you that you still have some money invested. That is the best money you will ever invest. I hope you don't regret it when the price is $80 AUD and you see all the missed gains. Lots of people took profits at the EMA approval. They missed out on 10x gains when they did that. Others have taken some off on the first FDA approval. It's not like this is the end of the story. There will be Australian / Japanese approvals. Japan especially is a large market. There will be new indications and new EMA / FDA approvals for those indications.
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LevelHeaded2000
Posted on: Oct 12 2019, 03:55 AM


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3000 shareholders is an accurate number as far as number of people who made a conscious decision to hold Clinuvel. Anyone who bought Clinuvel shares as an individual (not buying a mutual fund) using their broker are part of that list.

So, I do think it is pretty incredible. It really shows you how little publicity Clinuvel needs to really increase investment demand. If Clinuvel through marketing / presentations / etc convince just 300 people this is a solid company that just expanded the investor base 10%. Pretty incredible and achievable.

This is mostly for shareholdres of ASX. I imagine that ADR holders are not part of that list because that is basically like buying a fund (indirect ownership). I think I read somewhere that the ADR was somewhere around 30%, so maybe we can extrapolate the shareholder count at 5000.
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LevelHeaded2000
Posted on: Oct 11 2019, 06:47 PM


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The US does not have a fragmented regulatory / reimbursement issue like the EU. So, once it is rolled out in the US it should be basically nationwide.
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LevelHeaded2000
Posted on: Oct 11 2019, 03:25 PM


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Agreed. Clinuvel has so much of it's own IP that it still left to develop there is no reason to acquire more until they have developed more of what they got. It doesn't seem like management is looking to acquire anything, so that is good news.
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LevelHeaded2000
Posted on: Oct 11 2019, 12:14 AM


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Not really anything unusual. Look at any drug and there is post marketing work. Heck, look at the recently approved Vyleesi: https://www.accessdata.fda.gov/drugsatfda_d...rig1s000ltr.pdf
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LevelHeaded2000
Posted on: Oct 9 2019, 11:49 PM


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Generally stocks trade a bit down after approval highs, so given the US is now trading the next day after approval it makes sense that it trades a bit lower.

Don't worry, the highs met in australia (30 USD equivalent) will be seen again. I expect in 1-2 months as news items come out we will be moved solidly past 30 USD. Expect some down trading, consolidation for a month or so, and then an upward bull market again to blast through 30 USD.
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LevelHeaded2000
Posted on: Oct 9 2019, 11:01 PM


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It is doubtful that it is accurate that so many shorts closed. Likely it is a data error like occurred on August 13th. Evidence of this would be that if it were accurate it would mean that over 100% of every share traded was the result of short action. That there was less than 0% trades that were normal buyers and sellers.
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LevelHeaded2000
Posted on: Oct 9 2019, 05:51 PM


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Weeks Summary and Analysis

I have compiled a summary and observations of the last week because so much has happened it is hard to keep track of it all. After reading this I think everyone can agree we are just at the beginning. This company still has the potential to 10x from here.

  1. Phase IV trial indicates benefit is 6 hours versus 0.75 hours. Huge quality of benefit and much more justification for drug price
  2. In light of Phase IV trial the UK and other european countries will likely catipulate. Expect European revenues to double. Clinuvel offered to UK soon.
  3. Drug was approved unanimously by the FDA committee indicates strong support for the molecule going forward. Value is recognized unequivocally
  4. Drug is approved for 6 doses annually. This is generally more than in Europe. Europe will likely move to this too which means additional revenue expansion in Europe (50% more per patient in some cases)
  5. Given the phase IV trial there should be no problem with US insurance acceptance and reimbursement of the drug
  6. Company has foot in the door for EU / US markets. Additional indications are much easier to get approved than an original molecule. Expect add-on indications to go much more rapidly.
  7. CEO compensation package details companies priorities: A) clinical trials for new indications B) launch of OTC products C) new molecules (likely skin penetrating) moved to human stage D) commercial licenses for products in other regions
  8. Based on implied strategy revealed in CEO compensation we can conclude that A) Clinuvel plans to be a global dermatology company both in rx and OTC markets and likely eventually blurring the lines between the two B) they attempt to utilize partnerships / licenses to more rapidly develop their intellectual property.
  9. Vitiligo program will restart in the US. US seems like a more friendly regulatory market than EU going forward (personal observation). Type-C meeting requested with FDA to explore the ethics and clearance of said program.
  10. Company commits to keeping costs under control. Indicates it won't dilute like some biopharma companies. Indicates loyalty to shareholders IMO. Also indicates why partnerships / licenses will be a strategy to leverage to utilize other companies area of expertise more effectively
  11. Topical ready for clinic in 1 year.
  12. Company plans to move quick without educating competitors so it gains first to market.

From a "fundamental analysis" viewpoint. Clinuvel is trading at a PE of 122. For a biotech this is actually very good. Many of them trade higher and many trade at infinite PEs (continual losses). Hell, Netflix trades at 106 and it has far less growth potential than Clinuvel, IMO.

However, looking at Clinuvel's PE. That only includes revenue from a partial European rollout. Consider that in the EU most people are only getting 4 doses. When it moves to 6 that is a 50% increase in patient revenue right there. In addition, very few EPP patients are being treated. Look at the UK which has been denying the rollout. All of these things will disappear now with the new trial showing efficacy, IMO.

I expect EU revenue to double just from new patients. And, I expect revenue per patient to go up 25%. These changes alone would put the PE just from EU at 50x. Now, consider the US which is an on-average much wealthier market. It's revenue potential will be at least what the EU is. So, if nothing else changed and market cap stayed the same as today and income grew just due to EPP I expect in 2 years that the PE ratio would be 25x. That is not including any other indication.

Now, add in the fact this is a growth company, it will have new indications in the pipeline, and no early stage biotech trades at a small 25x and you will conclude that the market cap / share price will continue to increase over the next 2 years due to both 1) increased revenues from both markets + japan / Australia eventually 2) increase indications which will increase future expected revenue and thus cause PE expansion.

It is my viewpoint that the company can easily double in value from this price within one year.
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LevelHeaded2000
Posted on: Oct 9 2019, 06:19 AM


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For the people who thought it was a good idea to short 6% of the company I know you must be in a horrible place right now thinking very dark thoughts. You may want to consider this: https://suicidepreventionlifeline.org/


God bless
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LevelHeaded2000
Posted on: Oct 9 2019, 05:46 AM


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The FDA approval with the utilization of updated trial data is very important in terms of ability to get insurance to pay for it. This approval has gone better than expected.

For some people we are at a finish line. I say we are at the starting line with much success to come. This is right when Clinuvel really begins to shine and when it will start to gain mindshare with investors. This is when the real potential of Clinuvel and it's miracle drug will being to become apparent to everyone.

I am so excited to see what Clinuvel will be doing over the next 6-12 months and I will continue to hold and acquire. I have not held for so long just to end it when the race is just starting to get interesting. This approval will be rocket fuel for Clinuvel and it's drug platform development, IMO.


Shorters can eat shit!
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LevelHeaded2000
Posted on: Oct 9 2019, 02:28 AM


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Clinuvel moves slow. The trading halt was done until the 11th. Maybe that was foreshadowing on how long it would take clinuvel to release the info?
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LevelHeaded2000
Posted on: Oct 9 2019, 12:52 AM


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If the decision gets delayed a couple days there will be a lot of pissed off people on this forum who are staying up late. The trade halt was up to October 11th. I wonder if they suspected it could be delayed.
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LevelHeaded2000
Posted on: Oct 9 2019, 12:26 AM


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Smart trade !== inside information. Inside information is what I was disputing. And, we will see how smart the trade is considering the number of shorts are still open.
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LevelHeaded2000
Posted on: Oct 9 2019, 12:07 AM


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If they had inside information why let the stock go green for the last 3 days? They could have shorted another million shares at 28 bucks for some guaranteed profits.
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LevelHeaded2000
Posted on: Oct 8 2019, 03:26 PM


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What are people's expectations as far as the FDA approval bump? I personally am expected 10-20% price bump and not more. I believe investors mostly consider approval mostly priced-in considering it is approved in Europe for 5 years.

As a result, I expect the larger event for investors are things like the initiation of clinical trials for other indications. And, of course, continued revenue growth in Europe and US rollout. I think these events are moreso the bottlenecks to new investments at this point, so I expect larger share price increases in 4-6 months.
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LevelHeaded2000
Posted on: Oct 8 2019, 03:24 PM


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Not really. That is best case scenario for the shorters if everything is perfect. Remember, people who shorted at 37 likely long ago closed at 28. New shorts then opened at 28. There could be zero shorts still existing from the 33+ price. They could all be < 33. The short data does not really tell us.

You could add up all the gross short volume since shorts started. This would likely give you a huge number like 10-15 million. Then compare it to total shares shorted. That would give you an idea of the churn among the shorts.
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LevelHeaded2000
Posted on: Oct 7 2019, 04:29 PM


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I like the performance metrics of the compensation package. I expect Clinuvel to finally be pursuing multiple avenues in parallel. Luckily getting add-on indications approved for an existing drug is much easier than the first approval and Clinuvel will be much more experienced in the regulatory process. So, the company should get some additional indications under it's belt over the next couple years.

Good thing Clinuvel has no debt and a 40 million dollar war chest to fund some new trials and expand it's offering. The next year will be exciting times for investors!
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LevelHeaded2000
Posted on: Oct 7 2019, 04:23 PM


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Agreed. This demonstrates the company is very confident about an approval. So the approval announcement is expected Wednesday after the close of the US stock market?
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LevelHeaded2000
Posted on: Oct 3 2019, 05:57 PM


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Many of you have been with this company for a decade. What is a few more days? Nothing. For me, it does not matter. I am not selling. I want to see this company develop it's product lines and I think that will occur after FDA approval. I think this company has a long way to go both in developing it's drugs and in gaining investor mind share.

Remember the worst case scenerio is a delay, which is not the end of the world. It's not like Clinuvel has impending debt that is due. There is no way the FDA will reject the drugs absolutely. The FDA has become more patient-driven over the years. The drug is absolutely safe. There is no conflict of interest between a national healthcare system looking to avoid treating new patients and the approving body because the US has a mostly private-driven healthcare system. The drug has been in-use for something like 10 years in Europe (remember it started years before approval as a special access drug).

So, there is really no way the drug will be denied. Is it possible Clinuvel messed something up and it's delayed? Yeah, it's possible. However, even that worst case scenerio will resolve itself in a couple months. And, the much more probable outcome is that we get approved by October 9th and we can finally put the FDA behind us and begin looking at new indications, new trials, and new opportunities. Not to mention getting the drug into the hands of the needy as fast as possible so they can have a better quality of life.
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LevelHeaded2000
Posted on: Oct 2 2019, 09:50 PM


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Not sure why there is so much anxiety over the PDUFA correction. For anyone that still has cash on the side lines you have been gifted with a few more days to buy. Lucky you!
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LevelHeaded2000
Posted on: Sep 28 2019, 07:35 PM


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The last few days look to be driven by sellers more than shorters. My guess is some people are avoiding holding the stock during the decision event to avoid risk.

Regardless, I have made my bet and that is to be holding this company for a couple more years (certainly through the US rollout). The future of the companies market size will be determined within a few days. Don't forget that the company isn't dead if it loses the US. It still has Europe and other countries and it still has other indications.

The first Danish patient to receive the drug reported a few days ago shows that European product acceptance keeps expanding and that means EU revenues will keep growing.
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LevelHeaded2000
Posted on: Sep 25 2019, 05:27 PM


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Interesting that short volume was only 9% yesterday and we had a 5% green day. It shows how quickly the price can go up in the absence of short manipulation. My guess is that they simply slowed shorting for a day and that caused the price to rise a whopping 5%. Even if they net-closed shorts it indicates a big positive share price for a minimal short closing.

Pretty solid. It is safe to say the price is only being kept down by shorting. It all depends on approval. If it is approved the shorts will probably double the gain that would have happened otherwise. If it is delayed / not approved, then the shorts will likely half the loss that would have been otherwise.

I am 100% confident it will be approved. I just hope it doesn't get delayed / require an appeal.
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LevelHeaded2000
Posted on: Sep 19 2019, 05:29 PM


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While down 1.5% I am glad to see the increase in volume in both the US and Australia. Good day overall. Shorts better start getting nervous.
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LevelHeaded2000
Posted on: Sep 18 2019, 01:34 PM


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Of course Clinuvel will reach highs and beyond again. Shorting has no long-term relevance for a stock. It is a tool that only has effect once over a short time-horizon. Once the shares are shorted they stop causing further negative impacts. At that point shorted shares can only provide positive impact as they must be re-bought.
The shorts will break once the stock price rises. There is unlimited risk while shorting, so any shorter must be fairly conservative. No one wants to short the next stop that goes up 10x. That will be a lot of money lost.
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LevelHeaded2000
Posted on: Sep 14 2019, 08:32 PM


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It is a reminder that Clinuvel is doing good work and creating a positive change on people's lives. No matter what the company does I am proud to be part of this company. Here is a quote from the French page for EPP that touched me:
QUOTE
I am affected by the EPP, I am followed in the hospital of porphyria. The Scenesse is our great hope to have a pretty normal life and finally be able to enjoy finally with our 3 family life daughters outside the walls.

Sad that even with this great treatment some people are living in the dark due to the selfishness of government. Hopefully France stops it's cruelty and let's these people bathe in the light for the first time in their life.
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LevelHeaded2000
Posted on: Sep 13 2019, 02:04 AM


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The issue with Clinuvel is that the market does not perceive it all because it has been trying to fly under the radar for 10+ years. I have no doubts that when the market is finally made aware of Clinuvel that it will view Clinuvel and it's barbie drug very positively.
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LevelHeaded2000
Posted on: Sep 13 2019, 12:16 AM


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I agree with you. It seems some posters are not seeing the big picture. Approval is not the finish line or some event to sell. In my view, for this company, approval is the starting line not the finish line. It is when the company finally gets interesting again. This entire exercise up until approval has just been the warmup. The real magic of the company will occur after approval.

For that reason I will not sell after approval. I don't care about stats about how on average pharma companies trade a bit down for a while on post-approval highs. This company is still a multi-bagger. It has huge potential. I don't want to risk that chasing 10%.
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LevelHeaded2000
Posted on: Sep 12 2019, 01:54 AM


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The short are going up again. Basically, the stock has little liquidity right now. Holders are holding. Buyers are on the sideline. So, it is gets moved very easily based on whether shorts are increasing or decreasing. Small changes in shorts can make the stock go up or down quite a lot.

The good news is that if you believe the stock will be approved, then those shorts will be like throwing gasoline on a fire fueling the ascent ever higher. And, if by chance it does not get approved those shorts will reduce the downward trend as they re-buy their shares.

I am in the camp that believes in approval. Johnny indicated he thinks the stock could rise 75% on approval. I think so too. Contrary to how most biotechs perform though I suspect a large rise after approval. That is because the lips of clinuvel will finally be unsealed and they will be able to market this drugs future potential without fear.
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LevelHeaded2000
Posted on: Aug 30 2019, 03:25 AM


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I take a much less cynnical view than everyone on the board. I want the executives interest aligned with the shareholders. The performance metrics are for specific actions that will help the company. If they are succeeded we all benefit. One thing to consider is that Clinuvel is paying shares in place of money. If they did not offer the shares, then they would be forced to offer more money-in-hand whether to PW or to another CEO. It's not like the performance rights share come freely.

So, given that, the fact that PW and executives are taking shares in place of money compensation indicates they feel confident about the company's future.

Blijdorp owns 1.7 million shares and he is head of renumeration. He isn't selling. He doesn't get any performance rights, so he is not benefiting from this plan directly. He was not given his shares, but bought them on the market. So, he has real skin in the game. I am pretty sure that he is fully analyzing the options and doing what he thinks will make his investment 10x from here.

I can only hope the executives meet all the various performance goals. If they do, then Clinuvel will be executing well and that is worth a few %.
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LevelHeaded2000
Posted on: Aug 29 2019, 04:16 PM


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Short decline was short-lived. Shorts back at ATH. It does appear that it is taking more and more shorts to get less and less price decline. In general the amount of shorting has slowed recently. I hope they keep piling up at these low prices. It will make the short-squeeze all the more beautiful.
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LevelHeaded2000
Posted on: Aug 29 2019, 04:13 PM


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6 hours is a pretty big deal and it is not just 6 hours. It is 6 hours + reduced pain + dressing more normally. It is not a cure, but no one ever thought it was. The important thing is if it has value to the patients and it appears to have value considering the 95% continuance rate.


That is pretty significant considering that it is not just getting pills delivered to the house and taking them to continue it. It requires the patient to make a day-trip to a hospital that likely isn't close to them, take time off work, and then get minor surgery performed that can leave a scar. So, if it was not improving Quality of Life for the patient they would definitely quit taking it.
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LevelHeaded2000
Posted on: Aug 23 2019, 05:51 PM


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4 green days in a row. If I was a shorter I would begin to get very nervous. My guess is that once it is >= $20 USD that the shorters will begin to feel a bit of a panic.

Regarding any change in dividend, I hope that they do not raise the dividend much if any. I would actually prefer them to get rid of the dividend. Here are my reasons:
  1. Clinuvel will be transitioning to a growth strategy. They will need money to fund trials, so they have areas where dividend money can be spent for ROI. Unless they can get cheap debt financing there is no point to issue big dividends only to have to dilute later or severely limit the number of indications they can tackle in parallel due to lack of funds.
  2. A large portion of Clinuvel holders are holding the ADR (I believe it is 25% or so, but don't quote me). Any dividend provides negative shareholders value for ADR holders. So, the higher the dividend becomes the less sense it makes to hold the stock. The reason is because a substantial portion of the dividend gets eaten by the ADR administrator.
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LevelHeaded2000
Posted on: Aug 20 2019, 10:08 PM


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You may want to check out bitcoin or gold forums. That is usually where there is lots of cash activism.
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LevelHeaded2000
Posted on: Aug 20 2019, 06:42 PM


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Very glad to see the short decline was a data error. It was disappointing for those shorts to not have to cover on the open market. Hopefully the trend has now reversed and those shorts will have to make some very serious decisions about their investment soon.
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LevelHeaded2000
Posted on: Aug 19 2019, 06:18 PM


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Parallel fronts will begin after FDA approval. Clinuvel first needs to know exactly where it can sell it's drug before it can prioritize what fronts to pursue. If it is to be a Europe-only drug, then the fronts it pursues could be different than if it is a US/EU drug.
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LevelHeaded2000
Posted on: Aug 19 2019, 06:15 PM


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To me it seems like a turning point in sentiment among big players. No matter how it happened it required a big shorter to think "not much more downward pressure, so better close" and it required a big buyer somewhere to think "it's a good price probably going up from here".

Hopefully we get more positive sentiment change.
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LevelHeaded2000
Posted on: Aug 19 2019, 06:14 PM


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Posts: 536

The positive news is that a huge shorter now things most of the drop is gone. Hopefully it will start reversing. As to why there is no comparable volume the only thing I can think of is that volume is not reported if it occurs at the same brokerage.

As to why it would occur within 1 brokerage it could be either than the shorter had 1 million shares and covered their short with their own shares. In this case the short would have been a hedge. Though, it does not make much sense. If you are to cover the short with your own shares, then why not just sell the shares and avoid all the shorting fees? The only plausible reason would be to avoid any disclosures of changed shares for significant holders. However, that seems like a pretty big loophole in the disclosure law if true, so I doubt it is that.

A better possibility is that the shorter realized it is too illiquid to close the short on the open market. And, the broker knew someone that wanted to buy a lot of shares. So, the broker matched them together, so that they could both get what they wanted with minimal slippage.
Both of these theories depend on the idea that transactions within a broker can be off-market and not reported as public volume.
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LevelHeaded2000
Posted on: Aug 15 2019, 03:28 PM


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Posts: 536

At this point I think there is irrational shorting / selling exuberance. Let me explain: Shorting thesis has been reinforced with the declining price, so they keep shorting causing more price decline (self-reinforcing). Normal retails investors who are not smart enough to be on this board likely have been watching the declines and now see the whole market declining. At various price points along the way they get duped into panic selling some shares.

Buyers are sitting on the side lines. They are salivating, but they are all saying "Wait a bit more and maybe I can get a better price" thus they are not buying. These psychological mechanisms are reinforcing the price declines.

The good news is these mechanisms will all be quickly reversed as soon as the trend changes. All the buyers will be panic buying as soon as the trend reverses. So, the question becomes how long will the trend continue? Hard to say mostly due to the global stock context going on now (asx 200 down 3% as I type). However, my guess is that we are near bottoms. Today we also hit the mid point of the 52-week range. (11 to 39, current price 25).

I do believe that sideline buyers will be feeling more urgent to buy and sellers will become less willing to sell very soon. Simply because the stock looks very, very over-sold.
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LevelHeaded2000
Posted on: Aug 15 2019, 02:13 AM


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Posts: 536

Mainly because stock markets in general have been taking a beating. Clinuvel was one of the best performing stocks in the last year. Thus, I believe traders viewed it as extra high risk in these uncertain times (that which rises high must fall far).

The fall has largely happened. The stock is down over 30%. It likely will get caught up in the global stock sell off a bit more, but I think largely the bulk of the fall is in. There is, what, 7 weeks until the approval date? Assuming the short is done by various people at least some of them will want to take some risk off the table before approval date. Otherwise, they are at pretty big risk, especially the ones that are shorting even at today's low price.

So, my guess is within the next week or so that shorting will plateau. And, within a few weeks the shorts will begin to unwind and reverse. I have to imagine at least half will close prior to approval with the other half being closed in the approval pump.
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LevelHeaded2000
Posted on: Aug 10 2019, 02:13 AM


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Posts: 536

There were some attack articles talking about a Clinuvel bubble. They got the story wrong. The only bubble with regard to Clinuvel is the "short bubble". The number of shorts taken out and at the prices many of them were taken out just won't lead to a positive outcome for the shorters.

The shorters tried the same thing March - June at a smaller scale they lost millions. This time around they will lose even more millions.

The short squeeze will be beautiful.
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LevelHeaded2000
Posted on: Aug 7 2019, 05:00 PM


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Buying Clinuvel now is easy money if you believe the FDA will approve (I do). The approval bump seems likely to bring the stock back to ATH quite easily (40% gain). The rollout gains over the year to year and a half after approval I think will double the gains again. That is some easy money.
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LevelHeaded2000
Posted on: Aug 6 2019, 06:53 PM


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Posts: 536

The global stock backdrop is not doing favors for Clinuvel. The shorts on Clinuvel were likely a hedge against market-wide stock bear market. The logic being to short the best performing stocks with the assumption they have the most to fall.

Clinuvel is already significantly off it's high. It would have to increase nearly 50% in order to reach it's high from these prices. That is a pretty big increase!

When markets become bearish growth stocks are the first to get crushed. That is basically what is happening with Clinuvel now. Luckily, Clinuvel's upcoming growth over the next 1-2 years will likely be higher than the bearishness in that time period. Also, luckily Clinuvel income is government / insurance backed and resistant to inflation and since it has no debt the company is resistant to deflation.

I personally plan to hold for years. Even if someone planned to sell i think it would be wise to re-evaluate that plan. The stock move already happened. Significantly off the highs. Investors are de-valuing growth stocks currently. Now is not the time period to even think about selling, IMO.

If someone gets anxiety looking at volatile prices, then they may way want to step away for a few months because I am sure the ride will continue to be wild in both directions.



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LevelHeaded2000
Posted on: Aug 6 2019, 04:33 AM


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I expect Clinuvel's post-approval gains to be much larger than a normal biotech post-approval (I am referring to the 6-9 months post-approval not the approval-day bump). We can refer to this as the "roll-out gains" to differentiate it from the approval gains.

Clinuvel has had a huge marketing deficiency which will make it different than other biotechs. My guess is that this was strategy to not drive too much hype pre-approval. This is opposite of most companies. Most companies are hawking and marketing their shares / drug pre-approval because they are always in desperate need to sell more shares / acquire debt for funding. Since Clinuvel has not utilized any debt or much of any dilution, it was insulated from the need to whore itself out.

As a result, it has been flying very low under the radar and thus avoided any news articles of it being a "barbie drug". My guess is that post-authorization that it will ramp up marketing a LOT. Both to reach it's patient population (marketing direct to patient is legal in the US), but also to market it's shares to investors. It will no longer be scared of barbie drugs news articles, but will instead embrace it. Thus, due to this build up in marketing I expect the roll-out gains to be larger than a normal biotech.

In addition, in a few short months Clinuvel's 52 week rolling stock price window will look way better. Instead of investors performing technical analysis thinking "holy shit, it's up 300% in the last year that is scary!" they will see a much more normal looking increase as those early low prices disappear from the 52 week rolling window.
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LevelHeaded2000
Posted on: Aug 2 2019, 09:28 PM


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Posts: 536

Let me give you some clarity and context and hopefully I will save you from the worst decision of your life:
Clarity:
  • The company is profitable
  • The company has no debt
  • The management has shown it cares about creating shareholder value (unlike Palatin, for example).
  • The potential market size is enormous
  • The current market size is about to more than double.
  • It's forward PE is not actually bad for a biotech with no debt, profit, and upcoming indications.
  • New indications will be forthcoming
Context:
You would only think about selling if you think the share price is currently overvalued. You probably believe this because you have bought into the recent short-attack articles calling Clinuvel a bubble. The Clarity above should tell you why it is not a bubble. But, let's put it's share decline in context.
  • History: This looks very similar to previous runups and declines. For example, look at March 19th, 2019. Share price surged to $29.98 with 0.5% of the company shorted. It subsequently cratered to $21.80. Now, that was a brutal drop! And, it was actual sellers not artificial sellers (shorters). Scary! Well,we know what happened, by June 18th the stock price surged all the way to $38.55. Imagine if you had sold? It looked pretty bleak. You would still have lost 30% even at today's low price.
  • Today: The stock price surged to $38.55. It has dropped to to $30.84. However, to accomplish this smaller drop than we have seen even in the recent price it took a staggering 4.00%+ short of the company. That means to accomplish a smaller decline than in March 19th, it required an 8x increase in shorts. No one selling. All shorters. Now, imagine if you sell today and you miss the surge to $50.00. Sad!
We already know the FDA has no issue with safety and efficacy. Their only concern is manufacturing. Thus, we know this company's miracle drug will hit the markets and it's dreams will be realized. I would say this is 95% probable. The PE of the company is < 100. It's forward PE is much lower than this.

This was accomplished with only a partial roll out in Europe due to regulatory differences between each of the miniscule countries that inhabit europe. The US market is equal to Europe's. And, it does not suffer from the same regulatory rollout bariers as from Day 1 it is approved everywhere in the US (no secondary approvals necessary).

My point is that the rampup of income in Europe will continue. The rampup of income from the US, once approved, will be on a much shorter time scale than it took in Europe. Clinuvel's 100PE is actually pretty typical for a small biotech. Even one with massive debt. Clinuvel is not overvalued. It has no debt. It has good management. It has a miracle drug. It has growing revenues that will accelerate in their growth. It has small probability of any big dilution event. It is a safe bet. These prices are nowhere near too high.


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LevelHeaded2000
Posted on: Jul 31 2019, 12:13 AM


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Posts: 536

Anyone have earnings projections? Will it be flat or show growth? Hard to say. A small team distracted by this FDA process likely dropped the ball in new patient acquisition. Hopefully we see decent growth or at least flat. There does seem to be upcoming new treatment centers, so going forward we should get some new growth.


If we get good earnings, it will definitely be bad for the shorters who have shorted 3.5% of the company the last month. Fingers crossed.
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LevelHeaded2000
Posted on: Jul 22 2019, 01:10 PM


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Posts: 536

Last week the delayed short data showed a spike down in shorts. Some people may have assumed that last weeks trading was not short driven since shorts appeared to be closing.

That idea can be dispelled. Shorting is now officially, based on latest data, > 3% of the company: https://www.shortman.com.au/stock?q=cuv

Despite the huge amount of artificial sell pressure the stock price is holding up nicely. It was interesting how on Friday the big down day the next day the US barely had volume and didn't follow australia. It showed the artificial selling in australia reached a price where there were no willing sellers in the US.
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LevelHeaded2000
Posted on: Jul 19 2019, 01:10 PM


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Posts: 536

Today's trading day looks like the culmination of the short attack. It was a good effort between the coordinated articles that have recently come out that try to analyze Clinuvel as if it was Ford instead of a company that in October will more than double it's market size.


My only comment is: Not Selling. I will continue to hold even until after approval where I suspect the company will be reinvigorated now that they see regulatory acceptance. The doubling of the market size will see a doubling of profits and new indications will be incoming, IMO.
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LevelHeaded2000
Posted on: Jul 18 2019, 12:10 PM


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Posts: 536

There is no big seller. There is a big shorter: https://www.shortman.com.au/stock?q=cuv The fundamental difference being every shorter turns into a guarnteed buyer. This is not the same for a seller. They are fundamentally different market participants.

You are right. The fact the share price is as high it is despite this artificial sell pressure is a testament to how strong this stock is. Right now close to 3% of the entire company is shorted. This is not a selling. A sell is permanent. A short is neutral because the shorter MUST re-buy the the stock. Thus, every time a share is shorted a buyer is created (the shorter themselves) just at a different date in the future.

Here is what we know: It took a shorter shorting 3% of the company to bring the stock down below 35. Given that all shares shorted must be rebought we can be guaranteed stock price will back above 35.
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LevelHeaded2000
Posted on: Jul 12 2019, 02:27 PM


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Posts: 536

Just shorting. several months ago when we were about this same time away from the PDUFA date the exact same thing happened. There were a couple 10% drops. In fact, there was I believe a 22% one day drop. All short driven. The shorters eventually lost millions and the price recovered relatively quickly.

This time around, the shorters have already committed more than last time. I estimate around 2.5% of all shares are shorted almost all within the last 15 days. That is a LOT of short-term sell pressure. They will need to rebuy. Considering the high amount of artificual sell pressure in a short time period I would say the stock price is doing well.

Let me ask you this? Will they continue to be able to short 2.5% percent of the company every 15 days up to October? Probably not. I would guess in a couple weeks that shorts start to close. And we will get prices rising again. Slowly drifting towards October.


Don't check the price for a while. Don't give the shorters your shares. In a couple weeks this storm will pass. Happy holding.
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LevelHeaded2000
Posted on: Jul 10 2019, 12:07 PM


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Posts: 536

It's safe to say that shorts are at an all-time-high: https://www.shortman.com.au/stock?q=cuv

The shorting mirrors the previous shorting that was done in April the same time away from the PDUFA date. Seems to me that is algorithmic. Like last time they will lose millions. Here are some takeways:

1. Every shorter is also a buyer. These shorts create artificial short pressure in the near-term. Later-on it creates increased buy pressure.

2.The short pressure is unsustainable mathematically. From mid-june to July (2 weeks) 1.5% of the company was shorted. This amounts to about 30% of all share traded. That is a LOT of additional sell pressure in a short time-period. However, we know, this level of shorting is not sustainable. It has created enormous short-term sell pressure. But, to continue this same rate of shorting (1.5% of company every 2 weeks) likely cannot go on much further. They will simply run out of shares to short.

So, what happens when the short momentum stops? Well, suddenly, 30% of the sellers in the market disappear. As that is what the shorters are contributing. Not only that, but as they begin to close the shorts it will translate into 30% more buyers.

Happy holding people.
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LevelHeaded2000
Posted on: Jul 10 2019, 09:28 AM


Group: Member
Posts: 536

I was not meaning to implicate you in some grand conspiracy. I think you are doing good. I was putting people's minds at ease that there will be some market-relevant information gleaned. As you said, the consequences have already been revealed and paid. All the new information will do is provide more clarity into what has already occurred. There is not a downside to it.
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LevelHeaded2000
Posted on: Jul 10 2019, 03:51 AM


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Posts: 536

The good news is that I don't really see anything bad that can come from the plant inspection. A problem or not, it is solvable. It might delay the timeline, but that is the worst case scenerio.

There is lots of chatter on the board about Palatin. I do not see the relationship between Palatin and Clinuvel at all. The fact they both use a molecule that works on receptors that we classify as in the same family only makes it tangentially relevant in a superficial way.
Palatin is like a C category company where Clinuvel is an A category. Palatin's drug has a worse safety profile. The indications it is treating given the limitations of the drug really make one question the real market size. And, most importantly. the company is run very, very differently. Unlike Clinuvel which has been financially responsible and has returned value to shareholders Palatin has poor financials, dilutes, and has given up most of their profits via licensing.

The latter point is a real important thing. Palatin's poor licensing and dilution show just how important management is. We can complain about clinuvel being too quiet blah blah like children. But, the truth is, management has shown to be far more ethical in it's treatment to shareholders and cares about returning value to shareholders much more than comparable companies. For that the management should be applauded.
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LevelHeaded2000
Posted on: Jul 9 2019, 11:31 AM


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Posts: 536

Not down, but they are serving a bad certificate which makes your browser reject the site as a security risk. Definitely not a good look
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LevelHeaded2000
Posted on: Jul 9 2019, 10:58 AM


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Posts: 536

I have never requested public info from the FDA before. For education can you explain the process about how to do it?
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LevelHeaded2000
Posted on: Jun 25 2019, 04:27 PM


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Posts: 536

700,000 shares have been shorted the last two days. Expect to see more and more concern trolls and "I'm selling, getting out!" posts over the next few days. Shorters already lost a bunch the last time they shorted. Now it looks like they will try astroturfing.

Not falling for it. Holding until past $100.
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LevelHeaded2000
Posted on: Jun 11 2019, 01:05 PM


Group: Member
Posts: 536

The shorters look like they have disappeared. The week old data shows shorts down by 50%. Likely many more have been closed. Anyone who was convincing themselves that shorters must have some inside knoweldge should rest easy now. Not only did the vast majority of shorters lose big money, but they got so wrecked they are all disappearing.

It just goes to show you it is not always conspiracy theories. Oftentimes it is just fools. After all, anyone who would short a winner like Clinuvel is a fool.
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LevelHeaded2000
Posted on: Jun 8 2019, 11:04 AM


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Posts: 536

For the most part bail-in's are for funds that are less than the insured amount provided by the country. In the US for example that amount is $250,000 per person per institution. Other places might be lot lower such as hong kong it is < $50k.

To ensure you are bail-in resistant just ensure you qualify for the country's banking guarantees. It is unlikely a country would go back on their guarantee because if they did that it would likely cause a multiple generation distrust of banks which is bad for the country. Some countries have had this happen such as argentina.
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LevelHeaded2000
Posted on: Jun 4 2019, 03:29 PM


Group: Member
Posts: 536

People are being way too emotional IMO. Here is a rundown of the facts:
  1. Sharelooker posted many drugs that received 3 month delays. Almost all of them get approved. The 3 month delay is positive. It means the FDA is more likely to approve than reject IMO. otherwise, they would just reject.
  2. The safety / efficacy has been well understood. No issue there most likely. The FDA has raised issue about manufacturing. Thus, it is logical to assume the issue that caused the delay is manufacturing related. That is great news because unlike safety / efficacy manufacturing is 100% in the control of Clinuvel. Thus, it is just a matter of time.
  3. The FDA is not doing an advisory committee. This is more evidence there is no issue with safety / efficacy.
3 months delays suck, but in the grand scheme of things it matters little. This rocket ship will be going for years. For anyone who is not fully invested be grateful you have been given an additional 3 months to accumulate.
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LevelHeaded2000
Posted on: Jun 3 2019, 04:39 PM


Group: Member
Posts: 536

The stock is up 300% in a year and is I believe the best performer on the asx or at least one of them. I don't know what the complaints are about. All holders have been profiting nicely. This stock is golden and it's future is bright.
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