Clinuvel - innovativ + TOP

 es hat damit zu tun dass die Entscheidung der EMA ins 2. Halbjahr 2013 verlegt wurde

 

 www.clinuvel.com/en/investors/news-publications/.../2013/trading-halt

Kapitalaufstockung?

Marktzulassung?

es bleibt spannend...

 

............nachdem es seit Tagen wieder ordentlich gen Norden geht mit dem Kurs !  

"..........interessant !  

.........zumindest kurstechnisch. Woran liegst ?  

daran liegst....
Proposal to acquire all the outstanding shares in Clinuvel Pharmaceuticals Ltd  

hier ist es ganz schön mau mit news - wo gibt es gute aktuelle quellen zum nachlesen über die studien?  

...mal sehen wie es weiter geht!  

......mal sehen, was da noch so auf uns zu kommt?  

Das 100-prozentige Übernahmeangebot der Clinuvel durch Retrohin scheint kurstechnisch langsam Wirkung zu entfalten.

Scheinbar, schaut man in die einschlägigen Börsenmagazine, ist diese Aktie noch nicht entdeckt. So sind wir dann erst am Anfang der Kursralley!

Meine ganz persönliche Meinung!  

......"...beschert uns der heutige Tag!  

 

 

Aber sie zelebrieren hier schon jahrelang......."Kaufkurse, Kaufkurse.."

Interessanter wäre.......warum der Kurseinbruch von Heute ??

Gibt es Ursachen ?

Wäre irgendwie interessanter und aufschlussreicher als diese Push-Phrasen, oder ?


Gruß
Card  

......und schon steigt der Kurs rasant!  

.....wer weiß mehr? Dann würde das Papier durch die Decke gehen.  

Hier die dazu gehörende Pressemitteilung der EMA:

24/10/2014
Scenesse recommended for rare disease that causes intolerance to sunlight

Patients involved in discussions on benefits and risks of a medicine at CHMP for the first time

The European Medicines Agency has recommended granting a marketing authorisation under exceptional circumstances for Scenesse (afamelanotide) for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP), a rare genetic disease which causes intolerance to light. Scenesse is the first medicine for patients with this condition.

EPP affects fewer than 10,000 people in the European Union (EU). After exposure to sunlight, patients with EPP feel a stinging pain in sun-exposed skin. Prolonged exposure to sunlight can lead to an incapacitating pain, often followed by redness and swelling of the skin. Patients with EPP are often not able to lead normal lives, because they cannot spend time outdoors.

Scenesse acts by stimulating the production of a pigment called eumelanin, which naturally protects the skin against phototoxic reactions caused by sunlight.

During the evaluation of Scenesse, the EMA’s Committee for Medicinal Products for Human Use (CHMP) invited patients to share their experience of living with this condition. This was the first time that patients were involved in CHMP discussions on the benefits and risks of a medicine.

The CHMP decided that Scenesse should be recommended for marketing authorisation under exceptional circumstances. This type of authorisation can be granted for medicines that offer new or improved treatment options for patients with no or only limited alternatives, in cases where the applicant is not able to provide comprehensive data. In the case of Scenesse, there is a lack of robust efficacy data due to the difficulties in conducting placebo-controlled trials in this indication. Patients recruited in these studies are not willing to expose themselves to sunlight for fear of developing painful symptoms; therefore, the beneficial effect of the medicine on phototoxicity is difficult to assess.

The assessment of Scenesse was supported by data from the use of the medicine in more than 110 patients who were recruited in compassionate use programmes globally. These programmes allow the use of a medicine before it has been authorised when no satisfactory authorised therapies are available or when patients cannot enter a clinical trial. The CHMP heard from patients and healthcare professionals involved in an expert group that patients treated with Scenesse consistently reported improvements to their quality of life.

The CHMP has recommended approval for Scenesse on the condition that the applicant puts in place a robust risk managementplan that ensures close surveillance of the safety and efficacy of the medicine. As part of this plan, the company will establish a registry of patients to collect safety and efficacy data.

Scenesse has benefitted from a range of EMA tools to support innovation. The applicant for Scenesse is registered as a micro-, small- or medium-sized-enterprise (SME), and as such benefited from support and incentives offered by EMA. The Agency also provided free scientific advice to the applicant during the development of the medicine because Scenesse has an orphan designation.

The opinion adopted by the CHMP at its October 2014 meeting is an intermediary step on Scenesse’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.  

Hallo, bin absoluter Aktienneuling, habe die Aktie aber seit längerem im Auge, weil ich selbst von Scensse als Vitiligokranker profitieren könnte. Nun, da Scenesse zugelassen wurde, würde ich gerne investieren. Zur Zeit gibt es ja einen Trading Halt. Heißt das, dass ich jetzt eine Kauforder machen kann, welche dann am Montag zum Öffnungskurs ausgeführt wird? Oder ist das eher nicht zu empfehlen? Danke!  

Hier eine erste Stellungnahme von Clinuvel:
On Friday October 24, the European Medicines Agency’s (EMA’s) Committee for
Medicinal Products for Human Use (CHMP) concluded its scientific evaluation of
Clinuvel’s drug SCENESSE® (afamelanotide 16mg) for adult patients diagnosed with
erythropoietic protoporphyria (EPP). Based on its evaluation, the CHMP has issued a
positive opinion under exceptional circumstances in compliance with EC Regulation
726/2004 14(8). Clinuvel has compiled this brief Q&A document to address some of the questions anticipated
from the global EPP community as a result of the EMA decision.
What was the decision of the CHMP?
Based on its evaluation, the CHMP has issued a positive opinion, recommending that the EMA allow marketing
authorisation for SCENESSE® under exceptional circumstances in compliance with EC Regulation 726/2004
14(8).
What are ‘exceptional circumstances’?
This is a specific regulatory term applied to certain drug approvals. It means that the drug is recommended for
approval with strict conditions which Clinuvel must fulfil once the drug is being commercially distributed to
patients. The main activity will be to follow up patients for long time to ensure that safety and efficacy of the
drug is maintained.
Does this mean I can access the drug in Europe?
Not immediately. The CHMP’s decision must still be ratified by the European Commission in Brussels, a process
which will take time and may not be completed until the end of the year or early 2015. In parallel, Clinuvel
must complete the distribution requirements and logistics in various European countries. Following this
process, it is envisaged that the drug will be made available to EPP patients through the specialist treatment
centres in each country.
How much will the drug cost?
It is impossible to answer this question at present. It is Clinuvel’s intention to facilitate drug access for as many
EPP patients as is possible in a sustainable manner.
When will more information be made available about availability in Europe?
We expect to provide the community with an update before the end of 2014.
What impact does this decision have on the US FDA/SwissMedic/Australian TGA and other jurisdictions?
The main impact is that, as planned, Clinuvel will now approach and conclude discussions with other main and
leading regulatory authorities in each country to discuss what would be required to file for marketing
authorisation in their jurisdictions. No timeline can be provided for these discussions, however we will keep the
community updated on progress.

October 24, 2014

Good Job done!  

Rasanter Kurssprung in den USA, dann in Australien und dann wohl auch bei uns.....  

......bewegt sich hier ja höllisch was.

Nur eigenartig, das Clinuvel durch die deutschen Anleger noch so wenig Aufmerksamkeit erfährt.  

.....wie bei Santhera?  

Florian Homm hat sich auf Google Groups zu Wort gemeldet

Dear Uhohinc,

your research is amazingly in depth. You even quoted my book, Rogue Financier. That is thorough stuff.. I am leaving this little post with you. On November 5th I will hold a speech at a University in Erding, Bavaria, north of Munich before a few hundred students and about a dozen people from the media. Clinuvel will feature quite prominently in this speech as the investment, providing me with great emotional gratification especially after the EMA approval. I was fortunate to finance this company. Quite frankly, our funding prevented this jewel from going bust and we actively searched the market for credible, science oriented management. I leave this little commentary with you to make available to others on share scene and other boards. I have followed Clinuvel very closely for years even during my 15 months in prison fighting extradition to America. I will touch on a few issues (not just these very narrow financial concerns) that may be of interest to you and others:

Valuation:
In the absence of serious research the shares are absurdly misplaced. During my illustrious career I received numerous investment awards (european hedge fund manager of the year, top us specialty fund manager, number one germany fund, European pension fund, blah blah blah). I have written over 500 research reports for the likes of Fidelity, Merrill Lynch, tweedy Browne, VMR AG, ACMH Group etc etc... I have a reasonable idea of this business. Here we go:
Revenues of USD 40 to 70 Million for EPP is realistic. But get to the pretax or net profit figures! On EPP alone, Clinuvel may trade at only 5 times 2016 or 2017 earnings. I have not the slightest doubt that EPP alone is worth AUD 5-7 per share right now. You have to look at Vitiligo separately! This a sum of the parts evaluation. I was the original proponent to encourage CUV to consider Vitiligo, but Dr. Wolgen took it the critical step further: not as a stand-alone treatment but as a combination therapy. Here are some facts which will blow your mind: there are no less than 1.2 million vitiligo treatments per year. Some world class sources say the number may be between 1.5 and 1.8 Million. I love using lowish numbers in my models. If the low balling works and I do not have to twist the math - so much the better. It is utterly realistic that CUV may get USD 5K to 7K per vitiligo treatment. It is increasingly evident, that the combination therapy is so much more effective it will over a few years largely wipe out the traditional treatments. I would be very surprised if CUV does not reach abut half of the market in annual vitiligo treatments, certainly no less than 500,000 treatments a year as the market will quickly learn about CUV's vastly superior product. USD 3.5 Billion in sales. What do you thing the bit margins are on this product? It is not unrealistic that CUV generates USD 1 Billion or more in net profit by 2018/2019. Some of the things you say make serious sense as well. How about off-label use for extreme vitiligo cases? Or how about the hundreds of thousands who get skin cancer after organ transplants. Would CUV work there. Worth a try certainly. Always better than the risk of malignant, at times deadly skin cancer. Or how about those extreme Fitzgerald 1 types ultra prone to get skin cancer even with only modest sun exposure. What is beautiful about the modeling now is that with EMA approval and 95 percent likelihood of FDA approval the shares have basically done nothing. There is not a single first rate research report on CUV! That is incredible and difficult to fathom. It is also a once in a lifetime investment opportunity. Do not get lost in all the blah-bla micro details in these posts. Buy, put away and then cash out of your ten, twenty, thirty or forty bagger. Yes, that is possible and probable. There is no chance this undervaluation persists for more than 6 to 12 months. None. Vitiligo is progressing quite quickly, quarterly EPP profit figures will show exponential growth and patient numbers in the US and Europe may even surprise on the upside. For a proper valuation you need to strip out all R&D, OH and simply take COGS and Marketing/Sales. Vitiligo, the same but get ready for USD 50 Million to get to full FDA approval. If I use 50 million shares outstanding (conservative) CUV is worth 12 to 15 AUD per share at this very moment. 300 for EPP and 450 for Vitiligo. In an organized auction process, CUV would easily get USD 10 per share. Cash!

Florian Homm hat sich auf Google Groups zu Wort gemeldet

Dear Uhohinc,

your research is amazingly in depth. You even quoted my book, Rogue Financier. That is thorough stuff.. I am leaving this little post with you. On November 5th I will hold a speech at a University in Erding, Bavaria, north of Munich before a few hundred students and about a dozen people from the media. Clinuvel will feature quite prominently in this speech as the investment, providing me with great emotional gratification especially after the EMA approval. I was fortunate to finance this company. Quite frankly, our funding prevented this jewel from going bust and we actively searched the market for credible, science oriented management. I leave this little commentary with you to make available to others on share scene and other boards. I have followed Clinuvel very closely for years even during my 15 months in prison fighting extradition to America. I will touch on a few issues (not just these very narrow financial concerns) that may be of interest to you and others:

Valuation:
In the absence of serious research the shares are absurdly misplaced. During my illustrious career I received numerous investment awards (european hedge fund manager of the year, top us specialty fund manager, number one germany fund, European pension fund, blah blah blah). I have written over 500 research reports for the likes of Fidelity, Merrill Lynch, tweedy Browne, VMR AG, ACMH Group etc etc... I have a reasonable idea of this business. Here we go:
Revenues of USD 40 to 70 Million for EPP is realistic. But get to the pretax or net profit figures! On EPP alone, Clinuvel may trade at only 5 times 2016 or 2017 earnings. I have not the slightest doubt that EPP alone is worth AUD 5-7 per share right now. You have to look at Vitiligo separately! This a sum of the parts evaluation. I was the original proponent to encourage CUV to consider Vitiligo, but Dr. Wolgen took it the critical step further: not as a stand-alone treatment but as a combination therapy. Here are some facts which will blow your mind: there are no less than 1.2 million vitiligo treatments per year. Some world class sources say the number may be between 1.5 and 1.8 Million. I love using lowish numbers in my models. If the low balling works and I do not have to twist the math - so much the better. It is utterly realistic that CUV may get USD 5K to 7K per vitiligo treatment. It is increasingly evident, that the combination therapy is so much more effective it will over a few years largely wipe out the traditional treatments. I would be very surprised if CUV does not reach abut half of the market in annual vitiligo treatments, certainly no less than 500,000 treatments a year as the market will quickly learn about CUV's vastly superior product. USD 3.5 Billion in sales. What do you thing the bit margins are on this product? It is not unrealistic that CUV generates USD 1 Billion or more in net profit by 2018/2019. Some of the things you say make serious sense as well. How about off-label use for extreme vitiligo cases? Or how about the hundreds of thousands who get skin cancer after organ transplants. Would CUV work there. Worth a try certainly. Always better than the risk of malignant, at times deadly skin cancer. Or how about those extreme Fitzgerald 1 types ultra prone to get skin cancer even with only modest sun exposure. What is beautiful about the modeling now is that with EMA approval and 95 percent likelihood of FDA approval the shares have basically done nothing. There is not a single first rate research report on CUV! That is incredible and difficult to fathom. It is also a once in a lifetime investment opportunity. Do not get lost in all the blah-bla micro details in these posts. Buy, put away and then cash out of your ten, twenty, thirty or forty bagger. Yes, that is possible and probable. There is no chance this undervaluation persists for more than 6 to 12 months. None. Vitiligo is progressing quite quickly, quarterly EPP profit figures will show exponential growth and patient numbers in the US and Europe may even surprise on the upside. For a proper valuation you need to strip out all R&D, OH and simply take COGS and Marketing/Sales. Vitiligo, the same but get ready for USD 50 Million to get to full FDA approval. If I use 50 million shares outstanding (conservative) CUV is worth 12 to 15 AUD per share at this very moment. 300 for EPP and 450 for Vitiligo. In an organized auction process, CUV would easily get USD 10 per share. Cash!

Threats:
There are three: A takeover. CUV, at this price is a sitting duck. It needs to be on NASDAQ asap. Top senior management (mostly Dr. Wolgen) needs to stay for at least the next 5 years and he needs to upgrade his team for a rather demanding Vitiligo approval process. Unless you have been in this space for a few decades (I have) you do not appreciate obtaining regulatory approval for a treatment which simply does not fit into the classical approval methodology (placebo or double blind design was absolutely not possible). The Scenesse approval by the EMA was the first ever, which integrated patient/doctor groups in the decision making process. That is a monumental achievement. The product pricing is amazingly good and much better than I ever imagined when I got involved about a decade ago. I see shareholders moaning about compensation levels. That is beyond absurd. This company is already global, operating in Europe, Australia, Singapore and the US. Compared to those companies compensation levels are well below average and what I view as a serious risk - management only has a tiny stake in this company. Their interest are not properly aligned with shareholders. It is always the same risk. A well payed manager may sell out a company well below price if his personal stake is small. He may opt for a fat golden parachute instead. CUV top management owns about 4 percent of the company. Get real. 10 percent, some for EPP and milestones like NASDAQ and the mother of all approvals vitiligo. This is a serious risk. Of course an opportunistic takeover at AUD 7, 10, 20 or even 30 is another heavy risk. You are sitting on a potentially huge gold mine and someone literally steals it from under you. The third serious risk is execution. Dr. Wolgen is key and few very focused members of senior management. Retain, retain, retain and motivate. So simple. Upgrade that board and senior management for NSDAQ because this is no longer the Queensland Cup. There are so many clowns running around (an Australian dentist (madman on share scene), Retrophin under Shkreli, some suspect, "concert party" hedge funds) who have no idea what has been achieved and what remains to be done. This stuff is micro-management, persistence requiring the highest possible degree of credibility and operational focus. Regulators hate disruptions. Management disruptions, and all too frequent board shuffles are toxic and at best delay regulatory procedures. At worst they can derail them entirely. I have hired and fired hundreds of senior executives. Those wannabe entrepreneurs offer nothing but populistic generic hogwash. Madman has a sharp mind, but stick to the research Mr. Jones. I like what I read from you and Poontz as well, but get the big picture....grasp the complexity.

The Human Dimension:
I do not own a single share. I will not own a single share. I used to serve Mammon. I have zero motivation to pump CUV. I want millions to be treated and cured. I want people to be hopeful. My masters are God, Jesus and Mary. I am so grateful Scenesse was approved. I wish all of you great fortunes with CUV, but give some back to great causes when you cash in that CUV check. On a fifteen year viewpoint, Scenesse may even succeed to help those most likely to contract skin cancer. Vitiligo is very damaging emotionally. EPP suicide rates are very, very high. At least half of those obtaining organ transplants get skin cancer. Hundreds of thousands of lives may be saved, millions will improve. Many of these folks have been without hope. That is what pleases me most. CUV gives hope, not just superior investment returns. It gives me a kick, that between all the raids, dozens of IPOs, short sales, VC deals and so forth there is this one company which makes me happy to bee associated with: Clinuvel. How often in life can you invest and reap a serious fortune and do something really good at the same time? Well? I have done hundreds of deals in a thirty year career. Such a benign and virtuous mix is incredibly rare: once in a lifetime for me. So you intense investors.....do not forget the human dimension and consider if CUV becomes this multi-bagger as I am predicting (anybody who had bought Rogue Financier and bought CUV shares would have made more than 300 percent), give to those in need and those who are less fortunate than you.

Viel Glück

Florian

 

klingt doch viel versprechend?!?  

CUV.
4.900 30.67% 4.380 4.900 3.750 4.900 3.750 377,640

http://www.asx.com.au/asx/research/...o.do?by=asxCode&asxCode=CUV