Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Need....More....Powder
Just touched all time high again.
Congrats to all old timers and newcomers alike.
The next year will be eventful for sure.
Nice little bump up today. Hopefully we’ll get good news to solidify the pps soon.
What a night. Looking forward to US opening tomorrow.
The NDA is not yet submitted, it seems. But I will have to happen soon.
New products to be announced soon and increases awareness amongst investors in Germany seems to drive the sp up.
Did that NDA get submitted? Was that the jump in price around March 19th?
Since then a slow climb up even with seemingly no news. Seems good.
The next days and weeks will be eventful:
1) The NDA will (probably) be submitted within the next week or two.
2) May 20th: Launch of skin care line
3) May 23rd: NICE decision on reimbursement in GB
4) H1: Norway’s reimbursement committee decides (if within normal timeframe)
Yes, it's been moving up nicely the past year or so. Slow and steady.
Congrats to all still holding. ;)
In Reply to 'Jestiron'
Its amazing to see this move...
Yes, as expected but still very comforting.
Today will be another +4-5 % day.
If the company doesn’t confirm they submitted the NDA it will most likely fall back somewhat again until they do, but with PDUFA approaching we could easily double from here.
Its amazing to see this move...
Either Clinuvel has now completed and submitted the NDA or we are very close.
I still have November / December as potential PDUFA if we get priority review.
The next days and weeks will be eventful:
1) The NDA will (probably) be submitted within the next week or two.
2) May 20th: Launch of skin care line
3) May 23rd: NICE decision on reimbursement in GB
4) H1: Norway’s reimbursement committee decides (if within normal timeframe)
Post by ValueFox of SS:
Sphene Capital are indeed a very small and focused boutique, mainly providing IR-related services to small companies to increase awareness in the capital markets. In most of the cases, the companies are paying for the research reports - but in this case, the founder has initiated coverage on his own after discovering the company. I had a long conversation with him some weeks ago, also about the non-existing IR work and that they seem to refuse to allow contact with financial analysts to an extent where it appears to be an obsession. I guess that CUV is afraid of a large float ownership of retail investors who would happily trade in their shares at a 100% premium in a take-over offer - so they try to stay out of the spotlight of retail investor channels (that's the only way it makes sense to me in a rational manner).
I think while the reach of Sphene Capital is limited, I think we can try to multiply on it and help spread the word. I believe that this in-depth compilation is very unusual for an analyst report (because of its superior quality and research effort=, and at least for me creates far more reassurance than the back-of-the-envelope "research" we saw from Florian Homm.
Analyst coverage of Clinuvel.
Price target 12 months: AUD 31.70
http://www.more-ir.de/d/16065.pdf
I fully agrre with you, I've said hundreds time here on this Board, PW absolutely doesn' communicate in a proper way with his Loyal shareholder.
In principal PWshould be a trustwothy man. Just like me he finds his roots in Holland. Maybe living " Uotdoors" will do you more harm then good. The Dutch are very open minded. Maybe one of his parents has his roots elsewhere.
The Market hates uncertainty.my experience with him is that his presentations raises always more question then answers. Look T the history of the SP. Take a good look at the SP. Very predictable In 99% of the cases she went down. Strange that PW still hasn't find out that discommunication hearts the SP.
I personal don't expect that the numbers of patients have increased. I don't know what your thoughts are but I sell them again just a few days for the presentation and will buy them back some time later when the has bottomed. It will be business as usual in my believe.
"Buy on the rumors, sell on the news" . It works certainly in this case.
This one is aso a good one. " Never fall in love with the company"
CLVLY is easy to trade. I swingtrade this stock all the time. Buy on the lows, sell on the highs. This stock is very predictable candlestics are very precisely together with certain oscillators you find the right moments.
PW it's time you wake up!
This stock is hyped extremely. Strange, it's always happening when Clinuvel starts her downtrend. The volume speaks for itself. Somewhat over the 900! Absolutely not tradable. It' contingiously the same story. PW it' time you show yohur true face. You know what a shareholder deserves? Respect. That's what we're missing. Non communication. It 's time PW quite. Of course he has done a good job over the years but now we entered a new dimension. We need a CEO right now who understands what the word PR means. PW you harms the SP extremely, you're too conservative in your behvavior. Please step down. It will do the SP more good then harm.
No hard feelings but time has changes in the mean time!
One very important item you overlooked an I blame PW from that!
He absolutely doesn't communicate as you might expect from a CEO! He is a discommunicator. The baddest I've ever seen!
What the Market absolutely hates is "uncertainty" and we have constantly to deal with that phenomen. Behind the scenes he does absolutely a damn good job, i agree so far but he certainly neglects his Loyal Shareholders, that's also a fact!
We "hobble"from quarterly, half-year and year- report and in between Clinuvel(PW) gives us the feeling as if nothing happens, Clinuvel keeps his mouth shut as if nothing is going on between those four walls.
We're lucky that there are lots of professional Boardmembers who keeps eachother updated! But we're still keeps on guessing, we can't otherwise because we're not informed properly.
One of the reason why the SP runs up from time to time is because the CUV/CLVLY Boards are doing there homework very well.
Technical spoken CLVLY is starting dipping again.
One thing what the Market hates is Uncertainty! It hearths the SP.
Stan did mention a “hand over.” So I think it’s reasonable to assume that PW will head the company for 3 more years and then be gone.
I don’t agree with everything he does nor the huge salary. But I think he’s doing a pretty good job all in all.
PW is resigning in 2021 at the latest. I think he is motivated to move fast in the US once we have FDA approval. Until then, they will duck and stay under the radar.
Do you mean revenue numbers or what PW says about patient retention?
He certainly has said the later but the revenue numbers seem to go against that which is a concern for me. One would expect number of patients to grow over time (this early in launch at a substantial rate but given reimbursement issues at least at a modest rate) so if numbers are the same then they are losing patients (or perhaps even fewer treatments per patient then expected?).
Agree it could be just ordering patterns throwing things off with such small numbers you get a few big orders at end of one quarter and it makes it look artificially high (and hurts y over y comp and subsequent quarter).
The lack of transparency would make it hard to know for sure. I'm just saying its a caution and even though "off season" I'm very curious to see what the numbers are as I don't trust PW remarks want to see numbers.
Patient retention isn’t an issue if you look at the company’s numbers.
Seasonal differences and when the goods are actually paid for has an impact. If the clinics stock up or order close to next quarter and pay later it will cause a spill over to the next quarter.
PW is resigning in 2021 at the latest. I think he is motivated to move fast in the US once we have FDA approval. Until then, they will duck and stay under the radar.
Summer '19 sales start in US?
By company timeline its end of '19.... And when have management ever exceeded their timeline ?
I'm still curious what is happening in Y over Y sales and why we had a decline past quarter (shouldn't happen this early in a launch!) so even though "off" season curious to see if its a one-off or there are some potentially bigger issues commercialization/patient retention issues.
yes, it's clear, this stock is hyped for the moment! This stock has gone up on no news, that's to say there were no substainable updates to mention. We're all updated untill now! Oh I forgot one! Florian's Homm announcement. In my believe Florians announcement has been the Trigger. The Sentiment did the rest. Sentiment and the "Old News" is not enough anymore to keep the SP in those high regions!
It's nice to know , to hear again for many times in a row, that the Future is bright for Clinuvel. Is that a good fundament? This time it has to be translated, translated into real Figures.
It has been but Clinuvel is in a different stage right now entering a different Phase. It's changing from an Upcoming Biotech company into a Grown-Up one! The Market is waiting for the Big Event this time later next month, PW's presentation. When I'm right we've to wait untill the end of February before PW will present us the Financials. Lots can happen in the mean while!
Sales in the USA? If we're lucky the FDA opens her doors by the end of this year. Sales perhaps starting summer 2019.
UK, Switserland/Italy they are not cooperating that good. We're hearing nothing for months already.
Germany, there are Insurance companies who compensate there patients others not.
Benelux, Holland is the only one who pays the price Clinuvel is asking, already from the beginning when the EMA gave approval! France, Spain, etc.
In other words PW still has lots to negotiate here in Europe that's a fact.
Yes, Clinuvel is making money already here in Europe but it still will be very, very fragil in my believe.
Next year February will be a better timing. Hopefully the negotiations with lots of Insurers here in Europe doesn't take that long anymore, has ended at that very moment. The longer it takes, the.......!
That's why in my believe this short uptrend wasn't substainable. "The so called "Bright Future" has to be translated into Real Figures this Time!
Figures/Prove first this time. Sentiment alone, that's not substainable anymore!. Most uptrends were based on Sentiment. February, D-Day.
I'm not surpriced the SP started the downtrend again, in seacrch of a new, hopefully higher, supportlevel. Begin february I foresee a new uptrend untill the upcoming event. Personal I don't think the salefigures will surprice me. There is a big change they still will be at the low end. As long as talks go on there will be no substainable income.
I will not be surprised if we see the low $7's again for the moment.
Good buying opportunity. "Go with the Flow". It's a pity this stock isn't easily to short when she is in her downtrend. most of the time the volumes are to low.
Salesnumbers that's what counts at the very moment!
I think it’s a mix of several things.
Perhaps a mini pre-NDA filing run up.
In Germany Florian Homm is actively promoting the stock.
And then the chair’s newsletter yesterday:
Whilst the Board of CLINUVEL looks back on a very successful 2017 it must now look forward to exciting times ahead. The Group will engage in many activities on several continents, and we are expecting to see the first fruits of internal research coming to the public eye.
Insurers and payors worldwide continue to restrict availability of reimbursements to patients needing “orphan drugs”. Nonetheless, as a counter-measure, we continue to broadcast the clinical successes achieved in the countries that do offer financial support for erythropoietic protoporphyria (EPP) patients1 in recognition of SCENESSE® (afamelanotide 16mg) as a treatment.
The long-awaited highlight for 2018 will be the final submission to the US Food and Drug Administration (FDA) of what has been a challenging SCENESSE® dossier as part of the new drug application (NDA). Activating pigmentation by way of a hormonal therapy in light-deprived patients – EPP – has proven a difficult task for even the most experienced scientific regulators and consultants. However, as the European and Swiss patients have shown, our concept is not only effective but also of long-term benefit, it is hoped that the FDA will not wish for North American patients to be excluded.
CLINUVEL’s clinical and regulatory team have adopted a strategy of full and open communication with regulatory bodies, and the FDA has signalled receptiveness by having first accepted the clinical data for submission, then waived carcinogenicity studies, granted Fast Track Designation, and organised three meetings with relevant patients and experts while the formal scientific review is yet to be concluded. This persistent approach taken by our management team has brought us to where we are today as a company. Those that operate in our industry will have insight as to when the theoretical diverges from what is practical and optimal and so will better understand and support the decision pathways of CLINUVEL. It has not gone amiss that the Company’s application to the FDA is to be submitted during these politically and economically sensitive times, and we continue to take technical and substantive measures to best position the Company’s application.
2018 will be my last full year as Chair of CLINUVEL and I would certainly prefer to exit my role as Chair with the knowledge that shareholders, active investors and the domestic business community view CLINUVEL as a successful Australian pharmaceutical entity, and one of the few to have withstood the test of time while taking a New Molecular Entity from concept to patients in two major global markets.
It is essential that CLINUVEL is positioned to ensure that continuity and stability of success are guaranteed long-term. Having worked with previous executive teams, and certainly at CSL one led by one of Australia’s greatest CEOs, I have come to appreciate up close the efforts and accomplishments of our current CLINUVEL management against significant odds and challenges. In golfing parlance they are certainly besting par on the biotechnology course.
As Chair of the Board I have led and participated in intense deliberation on the positioning and vision for the future of the Company to ensure they are consistent with the interests of our stakeholders. All knowledgeable consultants and key investors in our industry have made it clear that continuity under current management is preferred and mandatory for us to reach our long-term objectives. As a Board we are privy to key management decisions, and it has become obvious to us, and those with a standing in the sector, that Dr Wolgen’s intelligence, vision and forthright manner will succeed where others may well have walked away. This approach has taken CLINUVEL to the success it enjoys today.
At this critical point in time the Board considered it absolutely essential to persuade our Managing Director to sign one final employment agreement to prepare the Company for a handover by 2021. With Dr Wolgen’s commitment to guide CLINUVEL through the next three years, as Chair I believe it secures the interests of those stakeholders who have provided funding for our programmes over the past several years.
Together with the retention of the Managing Director’s services and the need to retain key personnel and have a succession plan in place for senior staff, the Company has put in place a Professional Development Program for senior managers. As part of that program Dr Emilie Rodenburger will be assisted and guided by our Acting CSO Dr Dennis Wright to become the Company’s next Chief Scientific Officer.
CLINUVEL will attract a wider audience in 2018, not the least by diversifying its product offerings to new markets. The knowledge gained as a specialty pharmaceutical company, and the confidence gained among the top academic experts worldwide, will need to be translated into a continuum benefiting a wider market. CLINUVEL will launch its premiere non-pharmaceutical product lines under private label. These dermatological products will be complementary to SCENESSE®. Fitting our 2018 strategy, CLINUVEL will exhibit its first conference display in Asia and Europe, our main targeted markets. This will be discussed by our Managing Director in more detail over coming months.
For the next twelve months Management and Board will give its best to achieve our objectives, and it gives me a sense of great pride and humility to have served as Chair over the past years. May we all look forward to an exciting 2018.
Seems like some good share price increase so far this week. Anyone know why?
VERY STRANGE BEHAVIOR!!!!!!!!!!!!!!!!!!!!
CUV's daily's SP UP on reasonable volume, more then 30..000 while CLVLY's SP goes up on the lowest volumes I've ever seen. Yesterday 325! Today trades at the very moment, 1.000!!
In other words totaly lack of interest.
Real Nasdaq Listed, that's one of the main goals of PW. One thing is sure the US retailer has absolutely no interest in this stock.
looking at the SP of CUV it tells me that this went up later in the day only because of the fact that the Clinuvel Guru, Florian Homm keeps the liquidity floating, in other words no real support. This stock is hyped!!
What goes fast up, comes hard down. It's not the first time we all experienced that phenomen!! We've still a long way to go untill the end of March before we see hard figures.
Delay in the UK, delay in Europe, ungoing talks with the Insurance companies, Italy and Swiss who absolutely reject the ASKPrice!, delay in Norway, USA unpredictable!! Australia?
TWhat's missing? Real prove. "It will pay off at the end" When? That's the question!
False breakout!!! Absolutely not supported. NO Interest in this stock, certainly not for an upward momentum. Volume only 528!! Don't let yourself been fooled! This stock is going down in the coming weeks. The SP of CUV is clearly technical spoken in her downtrend. If CUV goes down, CLVLY follows, that's a fact. Nice try but it won't work. Low $5's within a few weeks.
Hopefully PW will surprice the Market with good news in March. Hopefully he has learned his lesson right now. What we're missing is open communication. That's one of the main reasons why the SP doesn't do what it has to do. Going up instead of heading South!
Hopefully PW update the Market in the meanwhile. 3 months, no news! That will do the SP more harm then good, in my believe.
http://www.asx.com.au/asx/share-price-research/company/cuv
CUV down AUS $0.30
From Sharescene:
QUOTE:
Google translate of that page suggests that afamelanotide has been added to the Norwegian list of drugs that are not covered by central insurance. Is there a speaker of Norwegian on here that can confirm?
It appears the advice was published at the same time that NICE published it's refusal. I wonder if that is co-incidence, or if they are linked.
I suppose if it is linked to NICE then this too will be part of the ongoing NICE negotiations/litigation.
Not a helpful start to the year".
https://lovdata.no/dokument/SF/forskrift/2017-12-20-2257
Unquote
https://seekingalpha.com/article/4128951-clinuvel-turtle-race-horse-qualities
Year after year PW and his team confrontated us with delays. The outcome of the AGM on the 28th of November didn't make the difference. Delays again! It seems PW and his team has an subscription on that.
THE NEWS is pusponed again. We've to wait untill the end of March 2018 before we might expect to see "Real Figures".
March 2018 D-Day, hopefully PW is well aware of that!!
What's the new low supportlevel? That's the main question right now.
Early on it was hoped a topical or oral solution would work for tanning, but that quickly seems to have proven to be not very effective.
Here only about half a million women use implants for birth control - so that may give a hint that implants won't see more than half a million users too. Then again don't underestimate the popularity of tanning here. Millions of people dedicate many hours and much money to tanning even understanding the risks. This product seems to actually reduce risks so might be more popular.
Most of the black market users here inject the drug since implants are not available yet. That seems to be effective, but I think even fewer would go for the frequent injections and side effects seem higher when injected.
I have read blogs and reviews from people on the trials for EPP and contrary to some recent reports most seem to think this drug is life changing. But I think that if the mainstream media gets wind of the pricing and if it proves to really be life-changing, there will be a big push to force the price down.
Forgetting price for the moment there are a couple things to consider:
1-While doctors do have flexibility to prescribe off label in the US the drug will have some sort of REMS making off label use unlikely.
2-I'm not into tanning but consider the delivery method do you think a lot of people will want a subcutaneous implant not to mention some AE's that go along with Scenesse for a tan?
3-There is the issue of COGS (not sure on what it is for Scenesse) too so they couldn't make the price too low.
IMO the best opportunity in tanning would be some OTC topical form of afamelanotide or some derivative molecule.
I don't think Scenesse is happening for Vitiligo either that's just my opinion based on a few things (poor trial, limited efficacy, company delaying development). Again I think a different molecule would be better suited for this indication.
That being said I really like Scenesse for EPP and other Orphan indications just wish the company was more competent at developing in these indications not to mention dealing with regulators and payers.
I have been following SCENESSE and it's predecessors and related products for about 15 years and first got interested in it for its potential to take over the $5 Billion (US) tanning industry. It seems right now there are only a few thousand users of the drug here because they have to get it off the black market. If this was approved even if just for EPP, doctors here in the US would likely prescribe it "off label" for cosmetic purposes.
However this will not happen in big volumes at the proposed pricing. I don't think the typical tanner would spend more than a few hundred dollars per year on this drug.
If they decided to take advantage of the off label use and lower the price to say $100 instead of the currently proposed pricing they would have maybe 10 million users here and I think the net profit would be higher.
But - I understand they have to pretend that wouldn't happen to get approval and if they lowered the price too much it would raise suspicions...
Time will tell whether this is a multi-billion dollar product or not. In the meantime they have to struggle through the approval processes.
Still a waiting game.
I don't agree with that. NICE is notorious for finding fault with new medicines being too expensive.
I don't agree with that. NICE is notorious for finding fault with new medicines being too expensive. Also look at what happened with PTC they got a positive recommendation but the pricing was not disclosed so reference pricing wouldn't be easily achieved. That is why its often one of the last to get reimbursement. Each government has their own policy. The Germany policy I've commented on earlier from my Intermune experience and Clinuvel did it all wrong IMO! Since there was (is) no reference drug for EPP and its an Orphan indication while still a complex process the German system is much more favorable. InterMune was the first to go through IQWIG and eventually went through arbitration but they had an initial price and sales before this! The process involved a mandatory reevaluation at set points (I believe it was 2 years or when costs to Germany system reached 50m Euro). I suspect the process was much harder being first and yet they started sales there immediately with one of the highest prices in the EU. Clinuvel would have been wise to hire/contract someone who new the process instead of wait what was it ~ 2 years to go there!
Many European countries look to NICE when establishing a price for reimbursement. So I do appreciate why Clinuvel went after NICE first. And I don’t think the battle is lost yet. Germany went through arbitration and I think NICE coukd eventually go through a similar process.
KRD posted on the CUV board in Australia that the SP of CLVLY went up $0,45! What he forgot to mention that it wasn't supported by good volume, only support by a very, very low volume, somewhat over the 3300!!!
Very tricky.
Technical spoken this is called "a False Break-out" Be warned. This upward momentum is not supported. I think it's only ment to give you the idea that CUV is in the uptrend again, which she isn't. The outcome of NICE in the UK gonna hearth this stock next year. At least it will take another year before Scenesse will be on the Market in the UK.
Pricing is one of the discussionpoints in the UK. Furthermore NICE isn't convinced that Afamelanotide is a Life-Changer for the EPP Patient.
About pricing. PW clearly stated Uniforming pricing is one of his goals. He has to keep this under control. If not he will get in big problems. Then it's payback time for all those countries who paid already the full some, like Holland!!!!!
In other words the talks in the UK perhaps will take more then one year from now! Let's say beginning 2019 Clinuvel gets green light in the UK. Then Scenesse isn't still on the Market in the UK!!
It will take at least 3 months, by the end of March when I'm right before we will hear any substainable news from PW. That's 3 months, sitting in The Waiting Room. Technical spoken the SP still is in the downtrend.
Technical spoken the first real supportlevel is in the low $4's.
Let's be clear. this is my personal view.
Here is a link to the NICE report (note there are some detailed PDF's available from this page)
https://www.nice.org.uk/guidance/indevelopment/gid-hst10009/consultation/html-content
Don't know why anyone is surprised if NICE didn't initially recommend Vertex's CF drugs there was no way they would recommend Scenesse especially if the company is sticking to the "uniform pricing" nonsense. Since they apparently have limited bandwidth to pursue concurrent reimbursements this should have been (very) low on the priority unless they were open to price negotiations (the main objective of NICE). Just another dumb decision by management no surprise here.
The downtrend of CUV still is in tact. AUS $7,28 at the very moment.
Yesterdays "green day" was a false break-out.
$7,00 comes insight. I think before the end of this year we're in the $6 range.
CLVLY should have stayed at $5,50 yesterday. Now she has to follow the same route back again, to the lowest point.
The downtrend of CUV still is in tact. AUS $7,28 at the very moment.
Yesterdays "green day" was a false break-out.
$7,00 comes insight. I think before the end of this year we're in the $6 range.
Sorry closingprice AUS $7,26. 15 min delay, I was to hasty.
Closingprice CUV AUS $ 7,27 - US $ 5,5775 (minus $0,17)
The bottom still not visible!
It feels as if the downtrend just started in Australia. Fasten your seatbelts.
What does the history of the SP tells us? (Candlesticks)
I personal focus myself on the chart of CUV. She is Leading! UR9 and CLVLY are followers, nothing more, nothing less! If Clinuvel Australia is in the up- or downtrend. Then Clinuvel (Europe) and Clinuvel USA follow automatically. Sometimes CLVLY still tries to move the other way(most of the time in cases when CUV starts her downtrend) but that's temporary, she knows that finaly she has to do what her big brother does, going down!
If you take a good look at the historical chart of CUV you ALWAYS see, most of the time, about a month before the official Data are released by PW, that the SP starts rising, the Market believes/hopes that "The Outcome" this time, will be good this time, better then last time, that PW finally has convinced the Market!
That "Move Up" is supported by high volumes and I agree with you partly hyped but also thinking that this time the outcome will be the Best! The day the news is printed the SP start easing and the same day or 1 or 2 days later the SP goes down again, seeking her old or if we're lucky a new higher supportlevel. With candlesticks you can most of the time easily pick out that moment. For me T.A. is a very helpful tool.
Why?
a. PW disappoints again as usual and;
b. the SP has risen much too fast, much too high, not in line with
the outcome!!
Conclusion: The SP has to go down, there is absolutely no reason to keep
the so called uptrend in tact.
AGM, The Quarter figures or whatever, it's alwaysthe same story, over and over again. Up on rumors and down on the news. Peace of cake.
All you have to do is sit and wait till the news is out. Does the SP goes down then that's a clear signal, sell on the news, the Market tells me "I'm disappointed".
The candlestick graphic unveils the truth. The sentiment is also priced in in every candle. For me she is leading.
I sell directly at that moment. The same I did after the AGM of the 28th of november. PW disappointed again. If we're lucky we'll see green lights from the FDA 6 months later then planned. PW still doesn't understand how to communicate with the Market. He loves "Hide and seek games". You can't go on keeping fooling the Market.
Of course finaly it will pay of, I agree with PW. The fundamentals are improving little by little, not enough, still no hard prove that from now on the only way is up. The Market hates uncertainty!!!
Let's be clear green light by the EMA doesn't automatically mean that the FDA will follow soon! How long ago did the EMA gave green light and where do we stand right now in the USA? There is still a possibilty that Scenesse is not allowed being brought in the US-Market.
What do you think the SP will do in the meanwhile untill The Next Presentation somewhere in March next year when I'm right?
My vieuw. First of all the SP will go further down, searching for a (new higher) or old supportlevel. That's what she is doing right now. When she finally has reached that point and in the meanwhile PW keeps his mouth shut, there is a "No News Show"untill the end of february next year, I can asure you that the SP starts drifting untill about the end of february, in other words she will be a death fish in the meanwhile and there is even a big change that she starts seeking for another low level on low, very low volumes.The waiting period in between is too long! The downtrend mostly of the time takes place on low volumes.
Buy on the rumors, sell on the news. That certainly goes up with the SP of Clinuvel. That's peace of cake. For years now that's the way it works.
In my believe the outcome in March, PW's presentation will be crucial for the rest of 2018. D-Day!
I warn you if then again, PW doesn't take the Market serious,doesn't give a clear statement I can asure you that the SP after the presentation will fall very deeply this time. Let's be clear that's my vision.
Technical Analyse works that's a fact. It gives me good advice.
I wait for the moment the chart tells me the SP has clearly bottomed out. Then I buy the same amount of shares back or somewhat more and I will wait for the next Hype.
Look at the chart of the last 5 years, what do you see?
The SP goes up everytime (good) news is expected and.......
yes, goes down after the presentation. Is that coincidence? Absolutely not. It unveils a clear picture of the sentiment in the Market.
End March 2018, D-Day! Clear answers, clear vue, hard figures this time if not then in my vieuw it's very wise to abandon the ship for a longer period of time.
Let's keep it clear, it's just a vision, my vision.
What's yours
They grossly under estimated the challenge of getting this approved. We are weeks away from 2018 and still not FDA approved, WTF, incomprehensible.
Cut PW's obscene salary and hire some talent, they should have done this years ago.
I have been long for many years and will see this through till the end, the end for me being FDA approval and with any luck a decent buyout shortly after.
What I’m not happy about is the fact that they don’t have a professional PR person.
I lean towards your second scenario. They probably offered the EMA data hoping that real life data would make up for trial data (that was not representative because of the difficulties getting patients to expose themselves to sunlight). Because of the extremely slow rollout partly due to the NICE fcukup they didn’t have enough patients online to offer the FDA sufficient data. I’m not really concerned about FDA approval. If I were, I would reduce my holding and I’m not. What I’m not happy about is the fact that they don’t have a professional PR person.
The company is notoriously misleading the market with unrealistic timelines and delays. But the risk of failure is very limited IMO. It’s just a matter of time.
I’m not expecting any bad news. Only possible delays before good news.
I don’t think there is much risk the FDA will reject the NDA. The patients meeting, acceptance of the data package and the carcinogenic waiver bodes well. The FDA wants to approve but needs more solid proof of efficacy to do so. The EMA post approval data will be the last piece in the puzzle and I expect Clinuvel will be finished analyzing by February.
My expectation is that they will file the full NDA in April, 2018. 2 months of validation and the formal review can begin by July, 2018. That brings is to H1 2019 for possible PDUFA.
In the meantime look out for possible NICE approval (reimbursement) in GB and new European countries online.
The company is notoriously misleading the market with unrealistic timelines and delays. But the risk of failure is very limited IMO. It’s just a matter of time.
CUV Australia, $0,16 down again
CUV Australia, $0,16 down again, closingprice $7,44 high volume!
Clinuvel continues here downtrend. Personal I believe this could go on for a longer period of time this time!
Why? No news show in the coming months. Not earlier then March before we hear anything from PW. The outcome of the AGM last november disappointed. That's the main reason why Clinuvel picked up the downtrend.
If that's all the news we get for the moment untill March '18 (3 months from now!!!) I can asure you that this stock won't see much upward momentum. Personal I will not be surprised if the SP ends up at his lows again, somewhere between the $3,50 and $4,00. That's to say if we're lucky!!
Followers
|
17
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
733
|
Created
|
05/27/10
|
Type
|
Free
|
Moderators |
CLINUVEL PHARMACEUTICALS LTD today announced plans to launch its novel drug SCENESSE® (afamelanotide) in the USA, with the first patient to be treated after 15 April 2020. SCENESSE® was approved by the US Food and Drug Administration in October 2019 to increase pain free light exposure in adult patients with a history of phototoxic reactions from the rare metabolic disorder erythropoietic protoporphyria (EPP).
USA DISTRIBUTION SCENESSE®
The distribution of SCENESSE® is planned in three phases. During Phase I, three selected hospitals and medical centers will be able to provide treatment to EPP patients. For Phase II, Medicare-Medicaid will need to complete its review of the SCENESSE® dossier and provide an opinion on National and Local Coverage for the treatment, as to be confirmed by the Centers for Medicare & Medicaid Services. The last phase will consist of direct distribution of the drug to a target maximum of 30 centers who will be trained and accredited by CLINUVEL.
INSURANCE COVERAGE SCENESSE®
During the first phase of distribution commencing 15 April 2020, patients will be able to receive treatment under Prior Authorization [PA]. PA is a decision by a payor that a healthcare service, treatment plan, prescription drug, or durable medical equipment is medically necessary and is included in a member’s (patient’s) coverage.
===================================================================
The technology behind Clinuvel’s lead drug, SCENESSE® (afamelanotide 16mg), has been in research and development since the 1980s when a small team of scientists set out to investigate methods of preventing skin cancer in humans. Clinuvel licensed this technology and has spent over A$20million optimising the chemistry of afamelanotide (the active ingredient in SCENESSE®) and developing a proprietary, controlled-release implant formulation.
Since late 2005, Clinuvel has focused on developing SCENESSE® as a dermatological drug for individuals at greatest risk from visible and ultraviolet (UV) light and as a repigmentation therapy. The company has a particular focus on diseases where no existing preventative treatment exists.
Clinuvel commenced a clinical program in 2006 which focused on the rare disease erythropoietic protoporphyria (EPP), a metabolic disorder which causes painful burning reactions under the skin after even brief exposure to sunlight. The goal of Clinuvel’s EPP program is to prove that SCENESSE® can provide patients with EPP protection from sunlight by reducing the incidence and severity of EPP reactions. The ultimate objective is to provide a better quality of life for patients. Since the start of the EPP program, the company has involved more than 250 individuals with EPP in its global clinical trials. Between 2005 and today, clinical programs have also been conducted for individuals diagnosed with a range of disorders, including polymorphous light eruption, solar urticaria and organ transplant recipients who are susceptible to an extremely high rate of skin cancers.
In late 2009, Clinuvel announced that it had expanded its pipeline to include a second drug candidate, named CUV9900. Based on the same technology as SCENESSE®, CUV9900 is still in early stage development.
2010 was a pivotal year for Clinuvel. In May 2010, SCENESSE® became the first dermatological drug listed under the Italian 648/96 law, prior to its formal approval anywhere in the world. This listing allows Italian physicians to prescribe SCENESSE® to individuals with EPP with the cost of the drug reimbursed by the Italian National Health System (Sistema Sanitario Nazionale, SSN).
Later in 2010, Clinuvel also announced that it would expand its program for SCENESSE® to investigate the drug’s ability to repigment skin in the common pigmentation disorder vitiligo. Following regulatory and ethical approvals, Clinuvel’s International SCENESSE® Pilot Repigmentation Evaluation (INSPIRE) program commenced patient recruitment in 2011. A Phase II study was completed in the USA in 2013, showing that the drug had a good safety profile in vitiligo and may assist in faster repigmentation in patients when used in combination with narrowband UVB phototherapy. A Phase IIb study of the drug in vitiligo commenced in 2014 in Singapore.
In February 2012 Clinuvel lodged its first marketing authorisation application for SCENESSE® for EPP with the European Medicines Agency. In December 2014 the European Commission approved SCENESSE® for the prevention of phototoxicity in adult EPP patients.
As of December 2014, more than 900 individuals have been administered afamelanotide in Clinuvel’s clinical trials program and through compassionate use and special access schemes. To date, the drug has maintained a good safety profile in clinical trials.
European Medicines Agency CHMP approves novel drug for erythropoietic protoporphyria patients under exceptional circumstances (ART 14 (8) OF REGULATION (EC) NO 726/2004)
EXECUTIVE SUMMARY
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is proud to announce that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has voted in favour of marketing authorisation (MA) of Clinuvel’s drug SCENESSE® (afamelanotide 16mg) for adult patients with erythropoietic protoporphyria (EPP).
SCENESSE® is a first-in-class drug (belonging to a new drug category). EPP is a debilitating, rare genetic disorder clinically regarded as extreme intolerance to light and UV (phototoxicity). An estimated 10,000 EPP patients are affected worldwide, 45% of whom live within Europe.
Clinuvel conducted five trials testing SCENESSE® in approximately 350 adult EPP patients across Australia, Europe and the USA. The first EPP patient received the drug in 2006. Clinuvel submitted its dossier for EMA evaluation on 6 February 2012.
In September 2014, it was announced that the EMA - for the first time in its history - was incorporating patients’ and physicians’ clinical experiences with SCENESSE® in the CHMP’s decision process.
EMA Decision
On 23 October 2014 in its plenary session the CHMP voted in favour of marketing authorisation of SCENESSE®. This decision takes into account the challenges and limitations of conducting clinical trials in rare and severe disorders and allows access to treatment for patients without alternative medcine.1 Marketing authorisation is given for distribution of SCENESSE® across 31 European states.2 The CHMP’s decision will now be sent to the European Commission for formal ratification, expected within 67 days.
Clinuvel and the EMA have agreed to a comprehensive post-authorisation pharmacovigilance plan to monitor patients’ safety long term. SCENESSE® will be distributed through academic and specialised centres.
Comment
“On behalf of the Board, I congratulate shareholders and patients, experts in the field and Clinuvel’s teams around the world,” Clinuvel’s Chair, Stan McLiesh said. “I have witnessed from our staff a decade long dedication and an enormous zeal which has come together for patients and all stakeholders in a marvellous outcome, one rarely accomplished in pharmaceutical development and which is now unique to Australia.”
“Medical innovation requires an exceptional focus with a consistent strategy, passionate team and long term trust from patients, expert physicians and regulatory authorities worldwide,” Clinuvel’s CEO, Dr Philippe Wolgen said.
“Today I am excited but mostly proud that Clinuvel overcame a number of hurdles from having identified an unmet clinical need and taken a molecule from discovery to final commercial product. I congratulate our Acting Chief Scientific Officer Dr Wright and his entire team for the extraordinary achievement.”
“This outcome greatly impacts Clinuvel, our further operations and intrinsic value. The immediate goal is to distribute the drug to European patients in the coming months, while we owe it to our American and Asia-Pacific patient community to accelerate the regulatory process for them to gain access to SCENESSE®,” Dr Wolgen said.
PIPELINE
Following the approval of Clinuvel’s lead product SCENESSE® (afamelanotide 16mg), the Company is actively pursuing an expanded pipeline of products from the melanocortin family, a class of drugs that includes afamelanotide. Two novel molecules have been announced: CUV9900 and VLRX001.
CUV9900 is an alpha-Melanocyte Stimulating Hormone (alpha-MSH) analogue. Initial research has shown that CUV9900 is a potent skin protectant. Clinuvel intends to launch CUV9900 in various new formulations. Formulation work has commenced and Clinuvel expects the first formulations to be available for clinical testing after the commercialisation of SCENESSE® in Europe.
VLRX001 is an addition to the family of melanocortin analogues which provoke increased and prolonged cellular activity. It contains a specific peptide sequence, designed to make it less susceptible to degradation than physiologic (natural) alpha-melanocyte stimulating hormone (α-MSH).
The VLRX001 development work was undertaken through Clinuvel’s majority owned Singaporean subsidiary, VALLAURIX and has leveraged the knowledge gained from long term experience with the clinical use of SCENESSE®.
Formulation work will focus on the development of VLRX001 for topical self-administration by patients. The transdermal product will initially be evaluated as adjuvant maintenance therapy in the depigmentation disorder vitiligo.
Overall, the development of VLRX001 is part of Clinuvel’s life cycle management of its portfolio of products to ensure long term use and value of its technology and assets. Clinuvel will hold all rights to the final product and indications through VALLAURIX.
UPDATED: NOV. 2017
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |