Clinuvel

Sarahjane66

Well-known member
So just got this email… This has really really hurt my head.. I invested in a wonder drug, believing in the drug, not the team bringing it to market. I believed it to be a biotech company not an entrepreneur that’s still learning after decades.
What is going on ? We need an experienced ambitious pharma / biotech at the helm to make clinuvel a globally recognised name. It should have been years ago

IMG_1844.jpeg
 

Sarahjane66

Well-known member
Nearly 3 year on from when our chairman issued this address to the asx:


He said we were stupid to complain because CUV would be worth $7.5B in 4 years. And where are we at ….barely 750m or 10% of his target.

The ridiculous thing is, at a current sp of $15.50 we would be 20% better off, having just put our money in a bank account!
Astounding ! Cloud cuckoo la
All the more reason to focus on serious diseases,
Stroke
MS
Neurodegenerative diseases
Vitiligo

All have high unmet needs and the risk-benefit ratio will be less of a concern, vis via this one paper.

The cosmetology clan side of the company can open a clinic in Mallorca, Ibiza, Las Vegas, and Dubai wherever they want, and set up O2 bars and hangover remedies they want to sell.

Leave the serious drug development to real drug developers.

Observed firsthand the same thing at a very large pharma company years ago that wanted to take an effective BPH treatment and morph it into a prostate cancer prevention product "all men should take" even when another product that tried the same failed with the same Mechanism of action.

Spent 750M to 1 Billion on the trials. In the end, they got almost identical results as the other big pharma there was a slight potential for increased risk of high-grade prostate cancer but reduced risk for low-grade prostate cancer.

Possibly because as you shrink the prostate you find more cancers.

In the end no prostate cancer prevention label in fact label was worse off.

Years later outcomes trials from 10's of thousands of patients for 20 plus years.

No increased risk of cancer...... no one remembers that as all the products' patents expired

Now used to prevent hair loss.

This same company passed on two very effective therapies for prostate cancer that went on to be multi-billion-dollar assets. Few in senior management were clueless and eventually "moved on to other interests".


The moral of the story is don't be greedy, focus on real medical conditions, and keep the use to populations with clear positive benefits over risk.

Complete the stroke trials, get the vitiligo trials completed, explore the high-need populations, and stop diluting your efforts.

Really demonstrating a need for substantiative pharma development experience on the board and within management.
Not duty-free salesmen and the like.
I totally agree it’s time now for big guns to take this wonder drug to where it should be. It’s been painful to see the non progress since EMA & FDA
 

mrdax

Moderator
Staff member
So just got this email… This has really really hurt my head.. I invested in a wonder drug, believing in the drug, not the team bringing it to market. I believed it to be a biotech company not an entrepreneur that’s still learning after decades.
What is going on ? We need an experienced ambitious pharma / biotech at the helm to make clinuvel a globally recognised name. It should have been years ago

View attachment 5215
This guy is insane.
How can one invent such bs?
Does he use ChatGPT?
I just tried to mimic his style, pretty easy:

1695106255218.png

This could be copied 1 to 1 into the next Newsletter and voila, done deal.

You just mix it up with a generic BS description, voila, next NL already written.
@CUV team: Thank me later.

>>> Describe the current situation many companies are facing due to global pandemic, global recession, inflation, macro economics. Please be very detailed in your answer.


In the vast expanse of the global business landscape, a tempest of unprecedented challenges has befallen companies far and wide. The interplay of a global pandemic, a severe economic recession, mounting inflation, and the intricate machinations of macroeconomics has woven a intricate web of complexity, demanding an acute understanding of the intricate interconnections at play.

First and foremost, the throes of the global pandemic have cast a long, dark shadow over the business world. The rapid spread of a novel virus has unleashed a wave of uncertainty, forcing companies to grapple with the ever-present threat of disrupted supply chains, reduced consumer demand, and the need to adapt to a remote work environment. The relentless march of lockdowns and restrictions has left many enterprises struggling to navigate this uncharted territory, as they seek to safeguard the health and well-being of their employees while simultaneously striving to keep their operations afloat. Moreover, the pandemic has engendered a pervasive climate of caution among consumers, as apprehension and financial constraints have dampened their willingness to spend, resulting in a downturn in sales and revenue for countless businesses.

Compounding this already precarious situation, the global recession has cast its long and ominous shadow upon the corporate landscape. The contraction of economies on a global scale has ushered in a period of economic uncertainty, as businesses grapple with reduced consumer purchasing power, diminished investor confidence, and the specter of layoffs and downsizing. The ripple effects of the recession have reverberated through various sectors, ranging from retail and tourism to manufacturing and finance, leaving companies struggling to weather the storm and sustain their operations amidst shrinking profit margins and a dwindling customer base.

Adding fuel to the fire, the specter of inflation looms large over businesses, adding yet another layer of complexity to an already volatile situation. The rising costs of raw materials, energy, and labor have sent shockwaves across industries, squeezing profit margins and forcing companies to re-evaluate their pricing strategies. The relentless increase in prices erodes consumer purchasing power, further exacerbating the challenge of stimulating demand and maintaining profitability. This inflationary pressure creates a delicate balancing act for businesses, as they strive to strike a harmonious equilibrium between cost control measures and the need to preserve quality, while simultaneously seeking innovative solutions to mitigate the impact on their bottom line.

In the backdrop of these multifaceted challenges, the intricate tapestry of macroeconomics weaves its influence over the corporate realm. The delicate interplay of fiscal policies, interest rates, and global trade dynamics shapes the environment in which businesses operate, presenting both opportunities and pitfalls. The shifting tides of international trade agreements, currency fluctuations, and geopolitical tensions introduce an additional layer of uncertainty, as companies navigate uncharted waters and seek to adapt their strategies in response to these macroeconomic forces.

In conclusion, the current situation facing companies is one of unparalleled complexity and uncertainty. The convergence of a global pandemic, a severe economic recession, inflationary pressures, and macroeconomic influences has created a perfect storm, demanding a keen understanding of the intricate interplay of these factors. Companies must navigate these treacherous waters with resilience, adaptability, and strategic acumen, seeking innovative solutions, forging new alliances, and embracing transformative technologies to weather the storm and emerge stronger on the other side.
 

Attachments

mrdax

Moderator
Staff member
Hey CUV management, I got some ideas for your next non-event:
💡💡💡💡💡

Prompt >> Act and write as the CEO of CUV, namely PW, and phrase a non-event, nothing to report, in enough words to fill a whole business newsletter.


Dear Valued Stakeholders,

Greetings from CUV! As we embark upon another exciting chapter in our journey, I wanted to take a moment to connect with all of you and provide an update on the latest happenings within our esteemed organization.

In the spirit of transparency and open communication, I would like to address the fact that the current period has been relatively uneventful in terms of significant developments or noteworthy achievements. However, it is precisely during these quieter intervals that we have the opportunity to reflect, recalibrate, and prepare for the dynamic future that lies ahead.

Our dedicated teams have been diligently working behind the scenes, ensuring the smooth functioning of our operations. From our tireless research and development department to our meticulous supply chain management, every aspect of our organization remains steadfastly committed to delivering excellence in all that we do.

At CUV, our unwavering commitment to innovation and the pursuit of breakthrough medical solutions remains our guiding principle. While the absence of any major announcements may be perceived as a lull, it is important to recognize that this tranquility serves as a foundation for our future endeavors. It allows us to consolidate our resources, fine-tune our strategies, and align our objectives as we set our sights on the next phase of growth and expansion.

Moreover, this period of relative calm provides us with an invaluable opportunity to nurture our valued partnerships and engage in meaningful collaborations. Our esteemed global network of healthcare professionals, regulatory bodies, and industry influencers continues to be a cornerstone of our success. By fostering these relationships and leveraging our collective expertise, we are poised to unlock new avenues of progress in the pursuit of our lofty goals.

Lastly, I would like to express my gratitude to all our stakeholders for their unwavering support and trust in our vision. It is your unwavering belief in our mission that propels us forward, even during quieter times. Rest assured, we remain steadfast in our commitment to creating value, generating positive impact, and driving meaningful change in the realm of medical innovation.

As we eagerly look towards the future, I assure you that CUVis on an upward trajectory, poised to make significant strides in the days to come. We eagerly anticipate the next wave of exciting developments, breakthroughs, and milestones that will shape our collective journey.

Thank you for your continued support and dedication. Together, we will continue to redefine what is possible in the realm of medical advancements.

Warm regards,
PW
CEO, CUV


Disclaimer:
Text was generated by AI.
Hope our beloved management potentially might reuse some of the orchestrated text to gain some efficiency
 

Silentreader

Well-known member
So we still in a bad mood in here huh? But as far as i remember, we are investors…and i can say, its the time my save my investment and one stop loss triggered…if we are getting red a few more % i will sell for the first time in years…and if that happens, i WANT TO, cause „the plan“ is not working and i am not happy with the management….no matter how bright the future could be, like rvbird said, we are now in the future from years ago and it does not look good. Anyone in here who can say something positive? Please? XD
 
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Frogster

Well-known member
I'm not sure if I'm misunderstanding this, but it appears that they are linking the "current strategy" with early voting.

Are they expecting bad news prior to the AGM that would jeopardize voting in favor of the current strategy, or is this just clumsy wording?

View attachment 5212
The stock reaction seems to send a pretty powerful message.

For me, there are many questionable aspects to this letter:


Inconsistent details:
p1: "The recently released Financial Year 2023 results exceeded expectations, with increase of revenues by 23%, a surge of net profit after taxes by 34%,"

Just half a page above, in the Executive Summary, Revenue was reported as up 24% and NPAT up 47%.

FWIW the AR reported Revenue was up 24%, NPBT up 33% and NPAT up 47%. Someone within the company should be picking up these annoying errors and inconsistencies before publication. They happen far too often.


Unclear logic:
p1: "Of note is that longitudinal analyses have not shown a correlation between the strength of the Company and its market value. Therefore, just from fundamental analysis, I have much confidence that CLINUVEL’s market value will recoil."

I understand the first sentence to mean over time there has not been a correlation between the fundamentals of the company and it's market value. The second sentence seems to argue this is about to change. Why might this change? The trigger is unclear.


Unclear messaging:
p2: "Under guidance of Dr Quadbeck-Diel, a submission to treat adolescent porphyria patients is under review by the European Medicines Agency (EMA) and, in anticipation of further discussion on long term effects in younger patients, we are preparing the CUV052 study in three centres."

To me this goes someway to imply a review might be concluded without the EMA receiving data from CUV052, and that data would only be useful later on. The 05/09/23 release was pretty clear the review will not conclude positively without acceptable data from the extra trial. Which is it? Ambiguous communication is unhelpful.


Really?:
p4: "CUV’s price is a mere indication of weaker markets for biopharmaceuticals."

Since 20/11/2019, and excluding today, CUV is down around 43% and the ASX Health Care Index is up 1.3%. Are you sure it's just the market for biopharmaceuticals which is weak?


Flaws:
p4: "Appropriate self-criticism is that our teams need to accelerate R&D and marketing activities to take a definitive lead in all markets."

Yes! I think many shareholders have been saying this for years. What are you doing to address these obvious flaws? In my opinion the lack of R&D progress (I'm including clinical development) is the single biggest factor which has weighed on the shareprice in recent years.


Boastful claims:
p4: "Since we are tracking ahead of our own projections in terms of profitability and cash resources, we will shortly share five-year objectives to 2028, taking into account all new activities to expand the Group."

The company has never shared it's own projections in terms of profitability and cash resources so when they make claims they are outperforming them (as they also did in the recent webinar) it's probably worth taking them with a large pinch of salt. Our most recent Board addition, Sir Andrew, said this in his 2010 paper "Successful leadership - how would you know?"

"A successful leader is successful in comparative, not absolute terms, and the starting point has to be against objectives. These will have to be set out beforehand (making them up afterwards is definitely not acceptable), may need to be changed over time to respond to changing circumstances and not all need to be fulfilled. But the degree to which a leader meets his or her stated objectives will be a key factor in judging success."

If the second half of the Clinuvel sentence means they will be sharing numerical targets for profitability in 2028 (and steps thereto) then great, I'll be pleased to see it. I'll also be mindful that we have zero factual evidence to judge how good they actually are at forecasting.


Catastrophising:
p5: "Each year we regard the Annual General Meeting as a democratic test of our strategies, a significant moment when members can decide the direction of the firm, whether you wish continuation of the business plan or for dramatic changes to personnel – and therefore strategy – including Board and subsequently management."

Under normal Director rotation elections, I believe only Blijdorp and Rosenfeld will be up for a mandatory election this year. Each shareholder can make up their own minds as to how to vote, but the concept that 2/7 Directors might change (this is not a prediction, advice or recommendation how to vote) does not logically equate to an automatic dramatic change in strategy. It might simply mean shareholders wish to see other individuals take responsibility for seeing that same strategy delivered.


Odd:
p5: "With full respect to shareholder rights assigned under the Australian Corporations Act (2001), if CLINUVEL’s members wish to exercise their rights and ensure the current strategy be continued in the best interest of the shareholders, it is recommended that you cast your votes prior to the AGM (to be held on 31 October)."

@Johnny H There is no requirement that shareholders cast votes before the AGM (though proxy nominations need to be made in advance of it) and even if votes, or proxy votes nominated to be cast by the Chair, are made in advance, these votes can be changed at any point (unless in the case of proxys an administrative deadline has passed). If votes are cast early then I guess it gives the company a couple of options:

1) to contact and try to "talk around" any votes not lodged in support of Resolutions
2) the opportunity to judge if they can be confident Resolutions will pass. Could they be thinking of publishing running tally of votes made in advance of the AGM? (I have no idea if this would be possible or not).
3) the opportunity to withdraw Resolutions which look set to fail. I don't think they can add new Resolutions after the AGM papers are issued and would need an EGM at a later date if Resolutions need to change to get across the line.

As ever, in all of this, do your own research and make your own decisions.
 
Last edited:

ChrizzlyAdams

Well-known member
Fair enough from Wolgen finally to admit the NOTHING before the agm. This means that part of the price decline after the AGM is already anticipated. Astonishing how smart our CEO is.

In order to improve the catastrophic image a little, I recommend the following short-term measures:
- Please refrain from sending any further obscene newsletters to shareholders.
- Stop the f*'* insider purchases of four-digit share packages (last was 1.532 in June). That's not even the opposite of convincing, that's deception and fooling.
- remove media coverage from your main page (at least this MxRodhe!)
- shut down https://lightskinscience.clinuvel.com/
- shut down the whole Cyacelle scam and give back that performance shares to the shareholder. This was not a market launch. At best it was a pilot launch, but the truth is it was deception and scam
- Pay the cash gifts to your maestro friend back to the shareholders
- Keep shifiting timelines (latest number is 2028) but in gods heaven hold on to your promise and resign in 2025
- Please no more of these fake videos of management and supposed research employees
- Please stop giving interviews to sleazepapers like mallorca magazine! (Were you at Ballermann 6 before)
- In order to prevent additional damage, it is best to say nothing more in public until you resign...
...

Everyone can feel free to add to the list
 

rvbird

Active member
The stock reaction seems to send a pretty powerful message.

For me, there are many questionable aspects to this letter:


Inconsistent details:
p1: "The recently released Financial Year 2023 results exceeded expectations, with increase of revenues by 23%, a surge of net profit after taxes by 34%,"

Just half a page above, in the Executive Summary, Revenue was reported as up 24% and NPAT up 47%.

FWIW the AR reported Revenue was up 24%, NPBT up 33% and NPAT up 47%. Someone within the company should be picking up these annoying errors and inconsistencies before publication. They happen far too often.


Unclear logic:
p1: "Of note is that longitudinal analyses have not shown a correlation between the strength of the Company and its market value. Therefore, just from fundamental analysis, I have much confidence that CLINUVEL’s market value will recoil."

I understand the first sentence to mean over time there has not been a correlation between the fundamentals of the company and it's market value. The second sentence seems to argue this is about to change. Why might this change? The trigger is unclear.


Unclear messaging:
p2: "Under guidance of Dr Quadbeck-Diel, a submission to treat adolescent porphyria patients is under review by the European Medicines Agency (EMA) and, in anticipation of further discussion on long term effects in younger patients, we are preparing the CUV052 study in three centres."

To me this goes someway to imply a review might be concluded without the EMA receiving data from CUV052, and that data would only be useful later on. The 05/09/23 release was pretty clear the review will not conclude positively without acceptable data from the extra trial. Which is it? Ambiguous communication is unhelpful.


Really?:
p4: "CUV’s price is a mere indication of weaker markets for biopharmaceuticals."

Since 20/11/2019, and excluding today, CUV is down around 43% and the ASX Health Care Index is up 1.3%. Are you sure it's just the market for biopharmaceuticals which is weak?


Flaws:
p4: "Appropriate self-criticism is that our teams need to accelerate R&D and marketing activities to take a definitive lead in all markets."

Yes! I think many shareholders have been saying this for years. What are you doing to address these obvious flaws? In my opinion the lack of R&D progress (I'm including clinical development) is the single biggest factor which has weighed on the shareprice in recent years.


Boastful claims:
p4: "Since we are tracking ahead of our own projections in terms of profitability and cash resources, we will shortly share five-year objectives to 2028, taking into account all new activities to expand the Group."

The company has never shared it's own projections in terms of profitability and cash resources so when they make claims they are outperforming them (as they also did in the recent webinar) it's probably worth taking them with a large pinch of salt. Our most recent Board addition, Sir Andrew, said this in his 2010 paper "Successful leadership - how would you know?"

"A successful leader is successful in comparative, not absolute terms, and the starting point has to be against objectives. These will have to be set out beforehand (making them up afterwards is definitely not acceptable), may need to be changed over time to respond to changing circumstances and not all need to be fulfilled. But the degree to which a leader meets his or her stated objectives will be a key factor in judging success."

If the second half of the Clinuvel sentence means they will be sharing numerical targets for profitability in 2028 (and steps thereto) then great, I'll be pleased to see it. I'll also be mindful that we have zero factual evidence to judge how good they actually are at forecasting.


Catastrophising:
p5: "Each year we regard the Annual General Meeting as a democratic test of our strategies, a significant moment when members can decide the direction of the firm, whether you wish continuation of the business plan or for dramatic changes to personnel – and therefore strategy – including Board and subsequently management."

Under normal Director rotation elections, I believe only Blijdorp and Rosenfeld will be up for a mandatory election this year. Each shareholder can make up their own minds as to how to vote, but the concept that 2/7 Directors might change (this is not a prediction, advice or recommendation how to vote) does not logically equate to an automatic dramatic change in strategy. It might simply mean shareholders wish to see other individuals take responsibility for seeing that same strategy delivered.


Odd:
p5: "With full respect to shareholder rights assigned under the Australian Corporations Act (2001), if CLINUVEL’s members wish to exercise their rights and ensure the current strategy be continued in the best interest of the shareholders, it is recommended that you cast your votes prior to the AGM (to be held on 31 October)."

@Johnny H There is no requirement that shareholders cast votes before the AGM (though proxy nominations need to be made in advance of it) and even if votes, or proxy votes nominated to be cast by the Chair, are made in advance, these votes can be changed at any point (unless in the case of proxys an administrative deadline has passed). If votes are cast early then I guess it gives the company a couple of options:

1) to contact and try to "talk around" any votes not lodged in support of Resolutions
2) the opportunity to judge if they can be confident Resolutions will pass. Could they be thinking of publishing running tally of votes made in advance of the AGM? (I have no idea if this would be possible or not).
3) the opportunity to withdraw Resolutions which look set to fail. I don't think they can add new Resolutions after the AGM papers are issued and would need an EGM at a later date if Resolutions need to change to get across the line.

As ever, in all of this, do your own research and make your own decisions.
The stock reaction seems to send a pretty powerful message.

For me, there are many questionable aspects to this letter:


Inconsistent details:
p1: "The recently released Financial Year 2023 results exceeded expectations, with increase of revenues by 23%, a surge of net profit after taxes by 34%,"

Just half a page above, in the Executive Summary, Revenue was reported as up 24% and NPAT up 47%.

FWIW the AR reported Revenue was up 24%, NPBT up 33% and NPAT up 47%. Someone within the company should be picking up these annoying errors and inconsistencies before publication. They happen far too often.


Unclear logic:
p1: "Of note is that longitudinal analyses have not shown a correlation between the strength of the Company and its market value. Therefore, just from fundamental analysis, I have much confidence that CLINUVEL’s market value will recoil."

I understand the first sentence to mean over time there has not been a correlation between the fundamentals of the company and it's market value. The second sentence seems to argue this is about to change. Why might this change? The trigger is unclear.


Unclear messaging:
p2: "Under guidance of Dr Quadbeck-Diel, a submission to treat adolescent porphyria patients is under review by the European Medicines Agency (EMA) and, in anticipation of further discussion on long term effects in younger patients, we are preparing the CUV052 study in three centres."

To me this goes someway to imply a review might be concluded without the EMA receiving data from CUV052, and that data would only be useful later on. The 05/09/23 release was pretty clear the review will not conclude positively without acceptable data from the extra trial. Which is it? Ambiguous communication is unhelpful.


Really?:
p4: "CUV’s price is a mere indication of weaker markets for biopharmaceuticals."

Since 20/11/2019, and excluding today, CUV is down around 43% and the ASX Health Care Index is up 1.3%. Are you sure it's just the market for biopharmaceuticals which is weak?


Flaws:
p4: "Appropriate self-criticism is that our teams need to accelerate R&D and marketing activities to take a definitive lead in all markets."

Yes! I think many shareholders have been saying this for years. What are you doing to address these obvious flaws? In my opinion the lack of R&D progress (I'm including clinical development) is the single biggest factor which has weighed on the shareprice in recent years.


Boastful claims:
p4: "Since we are tracking ahead of our own projections in terms of profitability and cash resources, we will shortly share five-year objectives to 2028, taking into account all new activities to expand the Group."

The company has never shared it's own projections in terms of profitability and cash resources so when they make claims they are outperforming them (as they also did in the recent webinar) it's probably worth taking them with a large pinch of salt. Our most recent Board addition, Sir Andrew, said this in his 2010 paper "Successful leadership - how would you know?"

"A successful leader is successful in comparative, not absolute terms, and the starting point has to be against objectives. These will have to be set out beforehand (making them up afterwards is definitely not acceptable), may need to be changed over time to respond to changing circumstances and not all need to be fulfilled. But the degree to which a leader meets his or her stated objectives will be a key factor in judging success."

If the second half of the Clinuvel sentence means they will be sharing numerical targets for profitability in 2028 (and steps thereto) then great, I'll be pleased to see it. I'll also be mindful that we have zero factual evidence to judge how good they actually are at forecasting.


Catastrophising:
p5: "Each year we regard the Annual General Meeting as a democratic test of our strategies, a significant moment when members can decide the direction of the firm, whether you wish continuation of the business plan or for dramatic changes to personnel – and therefore strategy – including Board and subsequently management."

Under normal Director rotation elections, I believe only Blijdorp and Rosenfeld will be up for a mandatory election this year. Each shareholder can make up their own minds as to how to vote, but the concept that 2/7 Directors might change (this is not a prediction, advice or recommendation how to vote) does not logically equate to an automatic dramatic change in strategy. It might simply mean shareholders wish to see other individuals take responsibility for seeing that same strategy delivered.


Odd:
p5: "With full respect to shareholder rights assigned under the Australian Corporations Act (2001), if CLINUVEL’s members wish to exercise their rights and ensure the current strategy be continued in the best interest of the shareholders, it is recommended that you cast your votes prior to the AGM (to be held on 31 October)."

@Johnny H There is no requirement that shareholders cast votes before the AGM (though proxy nominations need to be made in advance of it) and even if votes, or proxy votes nominated to be cast by the Chair, are made in advance, these votes can be changed at any point (unless in the case of proxys an administrative deadline has passed). If votes are cast early then I guess it gives the company a couple of options:

1) to contact and try to "talk around" any votes not lodged in support of Resolutions
2) the opportunity to judge if they can be confident Resolutions will pass. Could they be thinking of publishing running tally of votes made in advance of the AGM? (I have no idea if this would be possible or not).
3) the opportunity to withdraw Resolutions which look set to fail. I don't think they can add new Resolutions after the AGM papers are issued and would need an EGM at a later date if Resolutions need to change to get across the line.

As ever, in all of this, do your own research and make your own decisions.
Great analysis and a lot unpacked from the newsletter.
I don’t follow as closely as I used to as I took the chairman’s advice and sold out 80% of my holdings over the past couple of years.

The reasons were pretty simple - zero progress with CUV9900 and OTC’s etc after 5-10 years of promises, and an inability to execute the go-it-alone strategy.

Sure, they have $85m of EPP sales now, but it’s been how long since approval? Market penetration is dismal, but CEO and CFO keep crowing each year about exceeding expectations! How low can you set the bar!

Maybe they should have a look at the NEU strategy when benchmarking. Drug approved in April and sales running at $45m per qtr within 3-4 months.

Sure, they only get a royalty %, but they also get decent upfront payments, not waiting 7 years then worrying about patent expiry and competition.

 

Johnny H

Well-known member
Disclaimer:
Text was generated by AI.
Hope our beloved management potentially might reuse some of the orchestrated text to gain some efficiency
Eerily similar. The only things missing are:

-3 pages of text about macroeconomic conditions that are both theoretical and irrelevant
-Musings about Brexit, Ukraine, and the US elections
-Superfluous French-root words for added "sophistication"

If one were to look at Clinuvel's recent releases to market, they might conclude that Clinuvel's greatest accomplishment this year was not having deposits at Silicon Valley Bank.

It makes me want to, uh..... recoil.
 

Johnny H

Well-known member
Not to pile on, but another member drew my attention to a post on another investment forum.

On September 5th, 2023, Clinuvel announced that they were conducting a PK trial on 12 patients in order to receive a label extension from the EMA for adolescent EPP patients.

EMAEPP.jpg
Clinuvel very conspicuously uses the term "Upon scientific review", leading the reader to believe that the EMA has only recently reached this conclusion, and has just informed Clinuvel of their decision.

I recently criticized Clinuvel for not seeing this coming, and my opinion was that they should have known this a year earlier and should have already completed the trial (CUV 052)

I was wrong.

Clinuvel was actually informed of and agreed to the need for this trial 9 YEARS AGO, and in fact, it was a condition of EMA approval.

EMA2.jpg

Original here.

If that's not enough, the EMA again requested the study in January 2018, and Clinuvel deferred it.
EMA3.jpg

Original here.

So, in summary, in spite of it being a condition of approval 9 years ago, and receiving subsequent reminders from the EMA that it needed to be done, Clinuvel went ahead and applied for an adolescent extension without having conducted the trial. Unsurprisingly, the EMA said no. I suspect that the EMA said no at the outset of the application, but for whatever reason, Clinuvel waited a year to inform investors of their lack of progress.

This level of arrogance, incompetence, and deceit is just stunning.

Vote accordingly.
 
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